Orrin Hatch

Mr. HATCH

Mr. HATCH. Mr. President, I rise today in support of the nomination of Timothy J. Savage to the U.S. District Court in the Eastern District of Pennsylvania. My review of Mr. Savage's career as a litigator and public servant has convinced me that he will make a fine Federal judge. Following graduation from Temple University School of Law, Mr. Savage joined the Philadelphia firm of MacCoy, Evans & Lewis as a civil litigator. In 1974 he and a partner started the firm of Savage and Ciccone, where he turned to criminal defense work. Since 1976 Mr. Savage has worked as a sole practitioner in Philadelphia, moving in the last two decades to civil litigation and white collar crime specialties. Mr. Savage knows his way around the Eastern District, serving as a mediator in the Eastern District of Pennsylvania and as judge pro tem in the Court of Commons Pleas in Philadelphia County. Since 1977 he has served in a quasi-judicial role on the Pennsylvania Liquor Control Board, making evidentiary rulings, overseeing interrogation of witnesses, and authoring findings of fact and recommendations for Board decisions. Outside his law practice, Mr. Savage has served as counsel for a local civil association and for the local Boys and Girls Clubs for the last 20 years. He has also provided pro bono services to community groups, his church, senior citizens and served on the Philadelphia Bar Association's Volunteers for Indigent Persons panel. I am confident Mr. Savage will serve well on the Federal bench in the Eastern District of Pennsylvania. nomination of amy st. eve

Mr. HATCH. Mr. President, I am pleased today to rise in support of David S. Cercone, who has been nominated to the U.S. District Court for the Western District of Pennsylvania. Judge Cercone graduated from Duquesne University School of Law. Judge Cercone then clerked for Hon. Paul R. Zavarella on the Allegheny County Court of Common from 1978 to 1979. Judge Cercone has also been a sole legal practitioner in Pennsylvania. From 1979 to 1981, Judge Cercone served as the Assistant District Attorney for Allegheny County Court of Common Pleas and specialized in the prosecution of narcotics and violent crime cases. From 1982 to 1985, Judge Cercone served as the Pennsylvania district justice magistrate. In 1986 to the present, Judge Cercone was the youngest person ever elected, at 32, to the Court of Common Pleas for Allegheny County Pennsylvania. In 1993, Judge Cercone was appointed administrative judge for the criminal division by the Supreme Court of Pennsylvania. Judge Cercone implemented an accelerated plea docket to prevent jail overcrowding and to reduce case backlogs. He also established the first ``drug court'' in western Pennsylvania for the rehabilitation of drug offenders. In his capacity as Judge of the Court of Common Pleas for Allegheny County, Judge Cercone has ruled on many issues including medical malpractice, auto accidents, criminal homicide, murder, arson, insurance fraud, drugs, vehicular homicide, defamation, intoxication of minors and criminal conspiracy of an escape of six inmates from the Western State Correctional Institute. Judge Cercone has also prepared annual reports for the Allegheny County Court of Common Pleas, Criminal Division from 1994 to 1998. Judge Cercone has been rated ``unanimous qualified'' by the American Bar Association. I am confident Judge Cercone will serve on the bench with integrity, intelligence, and fairness. nomination of morrison england

Mr. HATCH. Mr. President, I rise today to support the nomination of Morrison C. England to be U.S. District Judge for the Eastern District of California. I have enjoyed reviewing Judge England's distinguished legal career, and I have concluded that he will make an excellent Federal judge in California. Judge Morrison C. England is a native of St. Louis and a graduate of McGeorge School of Law at the University of the Pacific. He has had more than a decade of private practice experience as a litigator and transactional attorney and has served for the past six years as a California state judge in Sacramento presiding over criminal and civil cases. In 1996 Governor Pete Wilson appointed him as Sacramento Municipal Court Judge and elevated him to Superior Court Judge on the Sacramento Superior Court a year later. He currently serves in a General Trial Court, presiding over both civil and criminal cases. Previous to his judicial service, Judge England acted as Referee and Judge Pro Tem in the Sacramento County Juvenile Court from 1991-96. Clearly he has the experience a Federal judge needs. Judge England also serves this country as a member of the U.S. Army Reserve, JAG Corps, holding the rank of Major. Judge England's nomination has been praised by his colleagues and Sacramento attorneys alike. He has home state support and my support as well. He will make an excellent Federal judge in California. Thank you, Mr. President. I yield the floor.

Mr. HATCH. Mr. President, I rise to support the nomination of David Godbey to be U.S. District Judge for the Northern District of Texas. I have had the pleasure of reviewing Mr. Godbey's distinguished legal career, and I have concluded, as did President Bush, that he is a fine jurist who will add a great deal to the Federal bench in Texas. Mr. Godbey has a terrific record as a civil litigator and as a highly effective state court judge. Following graduation from Harvard Law School, where he graduated magna cum laude, Judge Godbey clerked for Judge Goldberg of the Fifth Circuit Court of Appeals for a year, then accepted a job with Hughes & Luce, a Dallas firm, in 1983. For the next 11 years, he handled civil and commercial litigation in Federal trial and appellate courts in Texas and elsewhere. He accepted criminal appointments and represented clients in commercial arbitration cases. He specialized in technology litigation, appeals, public-law litigation, and oil and gas matters. In 1994 Mr. Godbey was elected to a judgeship on the 160th Judicial District Court in Texas. Judge Godbey has handled over 6,500 cases on the bench, including approximately 230 jury trials, and his reversal rate is well below 1 percent. It is clear that Judge Godbey is well prepared for the Federal district court bench. I know he will make a great judge in the Northern District of Texas. nomination of henry hudson

Mr. HATCH. Mr. President, I rise in support of the nomination of Richard Everett Dorr to the U.S. District Court for the Western District of Missouri. He is a man who has dedicated large portions of his career to public service, one of the qualities I most admire in a nominee to the bench. Mr. Dorr attended the University of Illinois at Champaign on a football scholarship. He graduated with a B.S. in Marketing in 1965. In 1968, he graduated with a J.D. from the University of Missouri at Columbia. During the next five years as a Judge Advocate, the nominee regularly appeared as either a prosecutor or defense counsel in criminal cases before Courts-Martial and Administrative Boards. During this period, Mr. Dorr also served as a legal advisor to Administrative Boards and as a Military Judge. He was also appointed to the Human Relations Council, an Air Force program designed to educate service members on appropriate behavior regarding racial diversity. Upon returning to private life, Mr. Dorr was an associate at the firm of Mann, Walter, Burkart, Weathers & Walter for 5 years. In this position he practiced general civil law, including real estate, business, domestic relations and general litigation cases. In 1978, he started his own firm, Harrison, Tucker and Dorr and continued his general civil practice. In 1996, Mr. Dorr became the Managing Partner of the Springfield office of Blackwell Sanders Peper Martin, a major law firm based out of Kansas City, Missouri. In this new position, he has concentrated on business and commercial litigation. Mr. Dorr was very active in the establishment of the Southwest Missouri Legal Aid Corporation. He served on its first Board of Directors from 1976 to 1982 and was the Corporation's President from 1978 to 1982. This organization provides legal aid to the poor who normally could not afford for their cases to be heard in a court of law. Unfortunately, this is Mr. Dorr's second nomination to the federal court. He was nominated by the first President Bush, but he did not receive a hearing. Throughout his life Mr. Dorr has given back to his community, first in the Air Force, where he championed the cause of human rights, and then by forming an organization that helped those who could not afford access to the courts. Clearly, Mr. Dorr has the character and temperament to be a fair and balanced federal court judge. I urge my colleagues to confirm this most deserving attorney. nomination of david godbey

Mr. HATCH

Mr. HATCH. Mr. President, I wanted to take a moment to note the passing of Timothy White, who was the editor-in-chief of Billboard magazine until he died unexpectedly a few weeks ago, leaving a wife and two young sons. He has been honored by many throughout the music industry, particularly for his trumpeting of new, not yet famous artists, working to give them space in a medium generally reserved for the already successful. We worked with Tim on artists' rights issues, such as work-for-hire, during my tenure as chairman of the Judiciary Committee. His efforts on behalf of all artists will be remembered. Looking to boost artists whom he felt deserved more attention, he wrote, ``At its high end, rock `n' roll can periodically fill in the hollows of this faithless era--especially when the music espouses values that carry the ring of emotional candor.'' I share the hope that true artists who offer a lift to their listeners from the weight of the world will be found by those seeking the joy and inspiration music can offer, and note with sadness the passing of a friend of that cause, as I also join my friends in the music industry in extending our condolences and best wishes at this difficult time to Tim's wife and sons. I trust they will find Tim's legacy a source of pride and solace in the coming months and years.

Mr. HATCH

Mr. HATCH. Mr. President, today, Senators Rockefeller, Chafee, Kennedy, and I are introducing legislation to make certain that States have adequate funding for the Children's Health Insurance Program, otherwise known as CHIP. I cosponsor this legislation to reflect my concern that, unless the Congress addresses this issue, thousands of children may risk losing their health insurance coverage. CHIP has proven to be an enormously popular program, which has provided much needed health insurance to literally millions of low-income children. It helps the poorest of the poor families who are not Medicaid-eligible. We cannot afford to stand back now and watch those efforts be undermined because of funding problems that Congress should correct. That is the intent, as I understand it, of the Rockefeller-Chafee bill. As most of my colleagues are aware, when CHIP was established in 1997, Congress committed $20 billion over five years and a total of $40 billion over 10 years for the program. For each fiscal year 1999 through 2001, Congress allocated $4.3 billion; yet for the fiscal years 2002 through 2004, Congress allocated $3 billion per year for CHIP programs. This so-called ``CHIP'' dip may reduce funding levels in States that are just beginning to ramp up their programs. I am concerned that while States will have some unspent CHIP moneys available to them, that those funds still might not be enough to address the ``CHIP dip'' and the expanding CHIP population. We need to deal with this issue and we need to deal with the nearly $3 billion in federal CHIP moneys scheduled to revert back to the Treasury in fiscal year 2002 and 2003. My cosponsorship of this legislation reflects my commitment to address these issues, although I recognize that there are a number of issues associated with this legislation that will need to be worked out. I accept the assurances of my fellow cosponsors that they will work with me to address those issues as the bill moves forward in the Finance Committee. Let me also add that I am aware that many of my colleagues have additional policy issues regarding the CHIP program that they feel should be addressed. Know I do. I am particularly concerned by recent legislation, approved by the Finance Committee, which would extend coverage under the CHIP program to pregnant women. Now, I wholeheartedly support providing expectant mothers health care assistance. But, I believe that before we extend coverage under CHIP to any adult, States need to demonstrate that they are covering, to the greatest extend possible, all eligible children. The CHIP program is one of my proudest accomplishments. I want to continue to maintain the integrity of this program. The only purpose of CHIP was to extend access to health insurance to poor kids. As one of the prime authors of the legislation, I can assure my colleagues that it was not our intent that the program be expanded to address the entire problem of health care for the uninsured a piece at a time. Covering the uninsured is a worthy goal and one which we need to address, but that was not the purpose of CHIP. We were dealing with a special problem: the up to 10 million children who did not have access to health insurance. We ought not lose sight of this. I am confident we can come to an agreement on measures to ensure that needy children receive the health care they deserve and thus I am pleased to join with my colleagues today.

Mr. HATCH

Mr. HATCH. Mr. President, I rise to speak on a subject related to the debate that we concluded yesterday--at least for the time-being--and that subject is pharmaceutical research and development. Yesterday, the Senate was unable to reach consensus on the appropriate structure and scope of the much-needed Medicare prescription drug benefit. This was unfortunate for millions of senior citizens across America, including thousands of Utahns. It is my hope that after the August recess it will be possible for the Senate to match the success of the House of Representatives and pass a Medicare drug bill. I know that we sponsors of the tripartisan proposal will not give up. Senators Breaux, Jeffords, Grassley, Snowe, and I will redouble our efforts to build support for our plan. It was also unfortunate yesterday that the Senate adopted S. 812, the Greater Access to Pharmaceuticals Act. This is the legislation that was originally introduced by Senators McCain and Schumer and virtually re-written in the HELP Committee in the form of an amendment sponsored by Senators Edwards and Collins. Let me be clear. I am supportive of reasonable changes to the Drug Price Competition and Patent Term Restoration Act, commonly referred to as Waxman-Hatch, or Hatch-Waxman. I do not oppose amending the Act. However, I do oppose the way in which it was amended, both in the HELP Committee and here on the floor. I have spoken at some length about the deficiencies of this bill-- that appeared only the day before the mark-up on July 10th, and was rocketed straight to the Senate floor the next week. While it was pending for over 2 weeks, it is accurate to say that the central matter under consideration was the Medicare drug benefit issues and that there was relatively little focus on the specifics of the underlying bill. Despite the lopsided vote yesterday, I have explained why I thought, and still think, that it would have been preferable to hold hearings on this potentially important but largely un-vetted bill. As ranking Republican member of the Senate Judiciary Committee, I have made known my objections to the manner in which the HELP Committee has acted to usurp the jurisdiction of the Judiciary Committee. When all is said and done, S. 812 is fundamentally an antitrust bill colored by civil justice reform and patent law considerations. We all know that S. 812 became the floor vehicle for the Medicare drug debate for one major reason the Democratic leadership recognized that if the regular order were observed and a mark-up were held in the Finance Committee, it was almost certain that the tripartisan bill would have been reported to the floor. I would point out to my colleagues that have just secured final passage of the conference report to accompany the omnibus bipartisan trade package. This bipartisan bill--perhaps the most important economic legislation of this Congress and a bill that will have lasting impact for years to come--came out of the Finance Committee. I think most would agree that the Finance Committee has a long track record of reaching bipartisan consensus on major issues facing our country. Perhaps if the Democratic leadership had given the Finance Committee the opportunity to do its job, the great success of the trade legislation would have been duplicated with respect to the Medicare drug benefit. Instead, we come to the August recess without a Senate Medicare drug benefit bill to conference with the House. We also come to August, almost as punishment for failing on the Medicare drug benefit issue, with the flawed HELP Committee substitute to S. 812 now adopted by the full Senate. We could have held hearings on the actual language of the substitute. We could have taken time to study the facts and recommendations of the major Federal Trade Commission report of the very provisions of law that S. 812 amends. We could have learned why the Patent and Trademark Office opposes the language of the bill. We could have learned what the Food and Drug Administration and Department of Justice, and the Office of the United States Trade Representative had to say about the bill. But we did not. Instead of taking the time for a careful evaluation of a potentially important change in the law, for the sake of short-term political tactics in an election year, we brought this bill to the floor in a poisonous atmosphere designed in part to vilify one segment of the pharmaceutical industry. While S. 812 completely revised most of the McCain-Schumer language and made several significant steps in the right direction, there are significant problems in several of the new features that so mysteriously found their way into the bill on the day before the mark- up. Since I have done so in some detail previously, I will not catalog these problems again today. And even though I still oppose various aspects of key provisions of the bill that passed the Senate in the denouement of the Medicare debate yesterday, I want to congratulate Senators McCain, Schumer, Kennedy, Edwards, and Collins for the substantial vote yesterday. Nevertheless, I hope that our colleagues in the House will study the Senate legislation, and consult with experts in the Administration, including the FTC, PTO, DOJ, FDA, and USTR, and other affected parties as they decide how best to address the matters taken up by the still barely three weeks' old language of the HELP Committee substitute to S. 812. Again, let me reiterate that I do not oppose legislation in this area. I concur with the majority of the HELP Committee and the Senate that changes need to be made. They just need to be made in a more measured fashion, taking into account the latest recommendations of the Federal Trade Commission. I plan to continue to participate in this debate as action moves to the House. I will work with the House, the administration, and others with a stake in the outcome of this legislation. Frankly, my first impression is that the FTC report provides some critical information and thoughtful recommendations for legislation. I was, of course, pleased that the FTC's first major recommendation-- allowing only one 30-month stay for all patents listed with FDA at the time that each particular generic drug application is filed with the agency--was precisely what I have advocated. The Senate-adopted version of S. 812 goes way beyond this policy. Why? I am also supportive of the FTC's second, and final, major recommendation, to require that any potentially anti-competitive brand name-generic agreements be submitted for FTC review. This is consistent with the suggestions I made to Chairman Leahy in connection with his bill, the Drug Competition Act, S. 754. I am still studying the three minor FTC recommendations that aim to promote price competition and hinder the type of collusive arrangements that on a few but very unfortunate occasions have grown out of the 180- day marketing exclusivity provisions of the law. Taken together these three recommendations appear to promote a very aggressive version of the use-it-or-lose-it policy I have advocated. Not that I pretend to understand the very complicated exclusivity, forfeiture, and transfer provisions of section 5 of the Edwards-Collins Amendment--and a review of the transcript of the mark-up suggests that I am not alone in my confusion--the HELP Committee adopted quasi- rolling exclusivity policy triggered only by an appellate court decision appears to be significantly at odds with where the FTC and I come out on this issue. It is very unfortunate that the rushed timing brought about by the tactically convenient decision to mesh S. 812 with the volatile politics of Medicare acted to minimize the value of this over-a-year- in-the-making, but still only 2 days' old, FTC study. As was demonstrated over the past two-and-a-half weeks, the charged atmosphere of election year Medicare debates on the Senate floor is not conducive to fine-tuning of complex and nuanced matters of antitrust and patent law. As co-author, with my House colleague, Henry Waxman, of the statute that S. 812 seeks to amend--the Drug Price Competition and Patent Term Restoration Act of 1984--I have a longstanding interest in legislation affecting pharmaceutical research and development and the continued growth of the generic drug sector. A key principle of the 1984 Hatch-Waxman Act is balance between the interests of developing the next generation of new medicines and making available generic copies of existing drugs. For reasons I have spelled out over the last two weeks, I am unable to conclude that this principle of balance has been observed in the bill the Senate adopted yesterday. No law as complex of the 1984 Act is so perfect that it cannot be improved as it measures up to the tests of time and changing conditions. In my view, there have been several unintended and unanticipated consequences of the 1984 law and other changes in the pharmaceutical sector that bear attention by Congress. I would like to spend a few minutes today to outline several issues beyond the 30-month stay and the 180-day marketing exclusivity rule that, along with the manner in which the drafters attempt to codify FDA's current bioequivalence standards, have dominated the recent Hatch-Waxman reform debate. On any number of occasions, I have heard proponents of S. 812 cite as their rationale for this legislation the need to restore the old balance and original intent of the Waxman-Hatch Act. I am afraid that--not only does the legislation fall short on the balance test but this misdirected attempt to look backward to the intent of 1984 may result in missing important opportunities to facilitate the future of drug discovery and increasing patient access to these new medicines. If you do not ask the right question, you will get the wrong answer. I wish to share my perspective on how the science of drug discovery and the pharmaceutical marketplace are changing. Historians will record the recently-completed mapping of the human genome as a major achievement in the history of science. Each day, progress is made on new avenues of biomedical research. For example, developments proceed apace in the field of nanotechnology--the precise manipulation of molecules at a sub-molecular level. Similarly, there is great excitement related to proteomics--the study of the structure and function of proteins and the interaction among proteins. We know that genes regulate proteins and, as our understanding of human genes becomes more complete, we will spend more and more time and effort on learning about the relationship between genes and proteins and how proteins carry out these assigned roles. As has been debated on this floor earlier this year and will undoubtedly be debated again this fall, there is great interest in the promising field of stem cell research. While there are a host of ethical issues that need to be addressed in this area, many leading scientists tell us that stem cell research may one day virtually revolutionize the practice of medicine. The nascent field of embryonic stem cell research may succeed in bringing forth the knowledge that will yield new diagnostics and treatments for a host of currently incurable diseases. We know that many, including more than 40 Nobel Laureates and virtually all leading science organizations, have concluded that the highly promising, emerging science of regenerative medicine will be advanced by the use of human somatic cell nuclear transfer as a method to develop stem cells. I mention this to comment on how our almost exponential growth in biomedical knowledge is affecting the pharmaceutical industry. Looking at all these developments compels me to make the following observation: When we adopted the 1984 Hatch-Waxman law, we were in an era of small molecule medicine and large patient population blockbuster drugs. Times have changed. It appears that we are rapidly entering an era of large molecule medicine and small patient population drugs. Some believe that we may be entering an age of literally single patient, person-specific drugs and genetic therapies. We are already in something of a transition away from old-fashioned chemical-based drug products to futuristic biologicals. This will not occur overnight and there will always be a place for old-style drugs in the therapeutic armamentarium. Experts remind us that this new wave of therapeutic protein molecules are more complex than the type of drugs developed in the past. To cite but one example, the molecular weight of Prozac is 345 daltons, compared with the biologic, EPO, which is 30,400 daltons and about 10 times the size of many common old-line drugs. Over the next decade and into the future, a great deal of inventive energy will be concentrated on developing biological products. The list of 66 approved medications using cloned recombinant DNA will almost certainly expand. The future of the pharmaceutical industry may one day be dominated by biological products. As we enter this new era of drug discovery, certain policy questions should be considered by Congress: Are our intellectual property laws relating to pharmaceuticals adequate to promote the large molecule, small patient population medicine? For example, currently under Waxman-Hatch, process patents are not eligible to receive any patent term restoration. Why should this be the case? If targeted patient populations get smaller and smaller and the production process patents become relatively more important than composition of matter patents, should we make process patents eligible for Waxman-Hatch partial patent term restoration? Is it possible that one day in the future there will be more drugs intended for patient populations under the 200,000 patient limit established by the Orphan Drug Act or even patient-specific biological cocktails and gene or protein therapies? If so, would it be appropriate to re-think and re-design any of our intellectual property laws? Unfortunately, S. 812 as passed by the Senate appears to give less value to patents and treats them more as targets for litigation than valuable insights to be respected. Another key question is whether Hatch-Waxman, as a general matter, adequately values pharmaceutical intellectual property relative to other fields of discovery? The American Inventors Protection Act which passed with a broad bipartisan consensus in 1999 permits all patents to be restored up to 17 years of patent life if there is undue administrative delay at the PTO. The 1984-adopted Hatch-Waxman law caps patent term restoration for drug patents due to FDA delay at 14 years. Moreover, most patent applications are reviewed by PTO in one and one-half to two years, so that the effective patent life for most products is actually 18 to 18.5 years. When all is said and done, most patents run appreciably longer than patents related to drugs due to the 14-year Waxman-Hatch cap. We must ask why time lost at PTO should be treated differently than time lost at FDA? Why should the proverbial better mousetrap be treated better under the patent code than a life-saving drug? Similarly, the Hatch-Waxman Act provides for five years of marketing exclusivity for all new chemical entity drugs, independent of patent protection. In contrast, it is my understanding that most European nation's and Japan have adopted a 10-year data exclusivity rule. Why not consider harmonizing and move to the European standard for this important information which, but for Hatch-Waxman, would be considered proprietary information? I want to commend Senator Lieberman, with whom I am working, for his advocacy of an aggressive set of intellectual property incentives in his bioterrorism legislation, S. 1764, that are designed to stimulate the private sector to direct its inventive energies and financial resources to develop the necessary measures to counter biological, chemical, or nuclear terrorism. I will continue to work with Senator Lieberman as he refines his legislation, which among other provisions, provides for day-for-day-patent term restoration for time lost at FDA. The Senator from Connecticut understands the value of intellectual property incentives in facilitating biomedical research. We should all look closely at this approach in the area of bioterrorism and consider applying these principles to other important areas of medical research. Another major issue will be whether the current lack of Waxman-Hatch authorization for the review and approval of generic biologicals is sound public policy? Although the Senate failed to adopt a Medicare drug benefit this week, I remain hopeful and committed to working toward the day when we will get the job done for America's seniors. Part of the impetus behind the McCain-Schumer bill and other efforts for Hatch-Waxman reform is to help seniors reduce the sometimes staggering out-of-pocket costs of their prescription drugs. Given the enormous costs associated with providing only limited pharmaceutical coverage under Medicare, that for catastrophic expenses last year estimated by CBO to cost $368 billion over 10 years it is absolutely essential for policymakers to explore enacting regulatory pathways for biological products to enter the market once patents have expired. As we learned in the 1980s when Congress first passed, than unceremoniously repealed, a law which included Medicare drug coverage, the cost-estimates of providing this benefit will only go in one direction: ever higher and higher, and upward and upward. According to CBO's March 2002 estimates, those seniors who will spend greater than $5,000 in annual prescription drug costs amount to 10 percent of all Medicare beneficiaries. Astonishingly, they account for 38 percent of total prescription drug spending by Medicare beneficiaries today. By 2012, CBO estimates that these numbers will skyrocket. Fully 80 percent of all spending for drugs by Medicare beneficiaries will go to those 38 percent of the total Medicare beneficiaries with greater than $5,000 in annual prescription drug spending. This will represent the lion's share of total projected Medicare beneficiary prescription drug spending of $278 billion just ten years from now. We know that biological products are likely to be more expensive than old-line drug products. Sooner or later, we must face up to the generic biologics challenge. We literally cannot afford to continue avoiding this issue. Now that the HELP Committee has finished, for the time being at least, its foray into antitrust policy, patent law, and civil justice reform, perhaps it could find the time to hold hearings on matters that are actually within the committee's jurisdiction, such as the legal, scientific, and policy issues related to the FDA review of generic biologics. As far as I am concerned, the sooner we change the law, the better. As more and more biologics come onto the market, we will face transitional products issues and carve out requests that will greatly complicate the legislative process. I speak from experience--I lived through the so-called pipeline issues in 1984 and it was not pretty. Congress simply cannot, and should not, attempt to enact and sustain over time a Medicare drug benefit unless we seriously explore what steps must be taken to end an FDA regulatory system that acts as a secondary patent for biological products. Patient safety must never be jeopardized. The task will not be easy. In this regard I must cite an article by Lisa Raines, published in The Journal of Biolaw & Business in 2001 entitled, ``Bad Medicine: Why the Generic Drug Regulatory Paradigm is Inapplicable to Biotechnology Products.'' Lisa was a special friend to all of us interested in biotechnology. She had experience both in the public sector--at the old Congressional Office of Technology Assessment--and in the private sector--with the Biotechnology Industry Organization and Genzyme. One of the many tragedies of September 11 was that Lisa was among the passengers on the plane that was crashed into the Pentagon. We all miss her indomitable spirit and friendship. Let me stipulate, as the article points out, that it will be difficult to manufacture generic equivalents of biologicals. However, I do not think it is an impossible task. As we attack this problem we will need to adopt one of the mottos of the Marine Corps: the difficult we do immediately, the impossible takes a little longer. I think it would be wise to charge an expert organization such as the United States Pharmacopeia to convene a group of experts, in alliance with the FDA, to begin to identify the technical issues that need to be addressed in order to bring about bioequivalent generic biologicals, including clinical trials if necessary. Some will argue that generic biologics cannot be manufactured, but unless we try to invent a fast track approval process for biologics, I do not see how we will ever know how to overcome the technical obstacles. It seems to me that one of the highest priorities of the next Commissioner of Food and Drugs will be to make certain that the leadership of FDA's Center for Biologics is committed, in partnership with the private sector and academic researchers, to identifying the issues and attempting to find solutions to the many issues that need to be resolved in order to make generic biologics. I want to acknowledge that Senator Rockefeller has introduced a legislative proposal in this area although I have problems with his study and automatic pilot features. The last overarching issue that I will raise today is how the structure and strength of the research-based segment of the American pharmaceutical industry has changed since 1984. On the one hand, we have seen substantial growth in the biotechnology industry. There are now some 1,400 U.S. biotech firms, although only 41 of these biotech companies have any revenues from FDA-approved products. On the other hand, I think that Congress should consider whether there are any appropriate actions we can, or should, take today to make sure that America retains a vibrant research-based large-firm pharmaceutical sector. I have nothing against the several new consolidated multinational drug firms but we must never allow our national leadership in biomedical research to erode. I suggest my colleagues review the transcript of the March Commerce Committee hearing on the McCain-Schumer legislation and examine the thoughts of Senator Wyden related to the financial health and status of the product pipeline of the large drug firms. Senator Wyden, with his long ties to consumer groups like the Gray Panthers, is certainly no patsy of the drug industry. But the Senator from Oregon clearly understands that while we politicians always want to focus on how to help distribute the golden eggs--the new medicines-- to our constituents, we also need to pay attention to the health of the goose. It is true that the pharmaceutical industry has had a great run of success since about 1994 when the Clinton health care plan was rejected. But today's dry pipelines presage problems tomorrow. The fact is that the drug discovery business is a high risk, high reward endeavor and Congress can do real, and perhaps irreversible harm, to some firms if we choose the wrong intellectual property policies. We need to discuss if there are appropriate ways to increase our nation's biomedical research capacity, such as the set of proposals set forth in the Lieberman bill. We should not be so quick to vilify the research-based pharmaceutical industry as was done repeatedly for the last three weeks. We know what happened. Political and tactical considerations led some to believe there needed to be a villain in this Medicare debate. In a sense, history repeated itself as some took a page right out of the Clinton Administration play book. Here is how the book, The System, authored by David Broder and Haynes Johnson, two highly respected journalists, described the tactics of the Clinton White House in trying to pass its too grand health care reform plan in 1993 and 1994: . . . Clinton's political advisers focused mainly on the message that for ``the plain folks it's greed--greedy hospitals, greedy doctors, greedy insurance companies. It was an us-versus-them-issue, which Clinton was extremely good at exploiting.'' Clinton's political consultants--Carville, Begala, Grunwald, Greenberg--all thought ``there had to be villains'' . . . at that point, the insurance companies and the pharmaceutical companies became the enemy. Unfortunately, that strategy reappeared over the last few weeks and we lost an opportunity to debate in a more reasoned fashion the complex set of issues and delicate balance required in pioneer-generic issues that I have just described. Nor did we do any great justice in delving beyond the surface and into the substance of the issues addressed in S. 812. I have made it clear that my vision and preference for Waxman-Hatch reform is to help facilitate a constructive dialogue among interested parties. We all could benefit by a fair exchange of viewpoints on a broad range of innovator/generic firm issues, including the matters I have just outlined. The issues that are addressed in the HELP Committee Substitute to S. 812 are important issues. So are the notice provisions contained in Senator Leahy's bill, S. 754. Unfortunately, the politics of Medicare prevented the debate over S. 812 from unfolding in a manner that encouraged a thoughtful discussion of even these narrower set of issues, let alone the initiation of a public dialogue of the broader--and perhaps more significant in the long run--Hatch-Waxman reform issues that I have just described. I wanted to take this opportunity to set forth these ideas for the future consideration of my colleagues and other interested parties. I look forward to debating these issues in the future and to working with the House and other interested parties to further perfect the Senate-passed version of S. 812.

Mr. HATCH

Mr. HATCH. Mr. President, I rise today in support of the conference report to accompany the trade Promotion Authority/Trade Adjustment Assistance legislation. This landmark legislation is a careful compromise that will benefit the American public by creating new jobs and investment opportunities. I urge all of my colleagues to support this measure. This legislation is not only good for the citizens of Utah, it is good for all Americans and it is good for our trading partners, especially those in the developing world. In fact, almost 10% of all U.S. jobs--an estimated 12 million workers--now depend on America's ability to export to the rest of the world. Export-related jobs typically pay 13% to 18% more than the average U.S. wage. This legislation will help bring new jobs into Salt Lake City and across our state. Last year, Utah's manufacturers produced and exported $2.7 billion worth of manufactured items to more than 150 countries around the world. An estimated 61,400 jobs in Utah are trade-related and one in every six manufacturing jobs in Utah--approximately 20,300 jobs--are tied to exports. Trade is of great benefit to Utah's small and medium sized companies. Some 80% of Utah's 1,894 companies that export are small and medium sized businesses. As the Ranking Republican member of the International Trade Subcommittee of the Finance Committee, I make international trade a high priority. International trade plays two important roles: it strengthens the U.S. and world economy; and it is a powerful foreign policy tool. Free trade and respect for freedom go hand in hand. Mr. President, I believe that this measure is one of the most important pieces of legislation we will face this year. Trade promotion authority is vital to our national economy and security, benefiting American businesses and employees everywhere. Simply stated, it means more jobs, higher wages, and better products. Passage of this legislation is a significant victory for the American people, especially our entrepreneurs. It was President Bush's leadership that propelled Congress to address this eight-year drought in trade promotion authority. I remember well the meeting that the President convened in the Cabinet Room two weeks ago today to urge the trade bill conferees to get our work done before the August recess. Today's vote must be seen as a great vote of confidence in President Bush's leadership. I commend conference committee Chairman Bill Thomas and Vice Chairman Max Baucus for their leadership in expeditiously putting together this bipartisan compromise. Senators Breaux and Rockefeller played key roles as did Representatives Rangel, Crane, Dingell, Boehner, Johnson, Miller, Tauzin, Bilrakis, Burton, Barr, Waxman, Sensenbrenner, Cobie, Conyers, Dreier, Linder, and Hastings. A full conference agreement on three major bills--TPA, TAA, and the Andean Trade Pact completed in three days! That is exactly the way the Congress can and should act on behalf of the American people if we put partisan politics aside and roll up our sleeves and get to work. In particular, Chairman Bill Thomas performed a legislative tour de force last week. Everyone should know about his leadership and thank him for the way he worked to resolve issues with Senator Baucus and the other conferees. I am particularly pleased that we are adopting this bill in August rather than October or December. This will give the Administration's trade team led by Secretary of Commerce Don Evans, United States Trade Representative Bob Zoellick, Undersecretary of Commerce Grant Aldonis, and Deputy USTR Jon Huntsman--a Utahn I might add--an immediate opportunity to negotiate trade pacts that will bring new jobs home to America and help increases the demand for American goods abroad. Not only will passage of this legislation expand the Administration's ability to negotiate, and for Congress to review, trade agreements, the trade adjustment assistance provisions will provide re-training and health care benefits to those workers who lose their jobs due to foreign trade. We in Utah, home of Geneva steel--where 1,600 workers and their families are struggling due to the fact that unfair dumping of foreign steel has caused the plant to cease production--known full well that, while most will gain through trade, inevitably some will lose out and need transitional assistance. This bill provides $12 billion of such assistance over 10 years. This legislation will also reauthorize the Andean Trade Pact that expired last December. From my work on the Judiciary Committee, I can tell you that this is a vital trade pact as we help wean these nations away from economic dependence on the illicit drug trade. I want to associate myself with the remarks of Senator McCain on the importance of passing the expired Andean Trade Pact before some South American economies topple. This is a good bill. It is legislation that will have both short-term and long-term benefits. A strong vote for this bill will indicate to our trading partners that the United States intends to play the leadership role during the Doha Round of international trade talks. This bill will boost our economy which is still struggling to regain its footing. As we face a new type of war, the war against terrorism, it is important that we strengthen our relationship with our trading partners throughout the world. From mutual economic interests that come through trade, political alliances can form. This dynamic can only help us hunt down and deny safe harbor for any terrorists. At the least, our neighbors throughout the world will get to know Americans and our values and ideals. This will only increase our stature in the world. For all of these reasons, I strongly urge my colleagues to pass this bipartisan conference report on trade. Let's get the job done for the American public and pass this bill.

Mr. HATCH

Mr. HATCH. Mr. President, today, Senators Rockefeller, Chafee, Kennedy, and I are introducing legislation to make certain that States have adequate funding for the Children's Health Insurance Program, otherwise known as CHIP. I cosponsor this legislation to reflect my concern that, unless the Congress addresses this issue, thousands of children may risk losing their health insurance coverage. CHIP has proven to be an enormously popular program, which has provided much needed health insurance to literally millions of low-income children. It helps the poorest of the poor families who are not Medicaid-eligible. We cannot afford to stand back now and watch those efforts be undermined because of funding problems that Congress should correct. That is the intent, as I understand it, of the Rockefeller-Chafee bill. As most of my colleagues are aware, when CHIP was established in 1997, Congress committed $20 billion over five years and a total of $40 billion over 10 years for the program. For each fiscal year 1999 through 2001, Congress allocated $4.3 billion; yet for the fiscal years 2002 through 2004, Congress allocated $3 billion per year for CHIP programs. This so-called ``CHIP'' dip may reduce funding levels in States that are just beginning to ramp up their programs. I am concerned that while States will have some unspent CHIP moneys available to them, that those funds still might not be enough to address the ``CHIP dip'' and the expanding CHIP population. We need to deal with this issue and we need to deal with the nearly $3 billion in federal CHIP moneys scheduled to revert back to the Treasury in fiscal year 2002 and 2003. My cosponsorship of this legislation reflects my commitment to address these issues, although I recognize that there are a number of issues associated with this legislation that will need to be worked out. I accept the assurances of my fellow cosponsors that they will work with me to address those issues as the bill moves forward in the Finance Committee. Let me also add that I am aware that many of my colleagues have additional policy issues regarding the CHIP program that they feel should be addressed. Know I do. I am particularly concerned by recent legislation, approved by the Finance Committee, which would extend coverage under the CHIP program to pregnant women. Now, I wholeheartedly support providing expectant mothers health care assistance. But, I believe that before we extend coverage under CHIP to any adult, States need to demonstrate that they are covering, to the greatest extend possible, all eligible children. The CHIP program is one of my proudest accomplishments. I want to continue to maintain the integrity of this program. The only purpose of CHIP was to extend access to health insurance to poor kids. As one of the prime authors of the legislation, I can assure my colleagues that it was not our intent that the program be expanded to address the entire problem of health care for the uninsured a piece at a time. Covering the uninsured is a worthy goal and one which we need to address, but that was not the purpose of CHIP. We were dealing with a special problem: the up to 10 million children who did not have access to health insurance. We ought not lose sight of this. I am confident we can come to an agreement on measures to ensure that needy children receive the health care they deserve and thus I am pleased to join with my colleagues today.

Mr. HATCH

Mr. HATCH. Mr. President, I rise today in support of the nomination of Henry E. Autrey to the U.S. District Court in the Eastern District of Missouri. I have enjoyed reviewing Judge Autrey's distinguished legal record, and I am confident that he will make a fine Federal judge. Judge Autrey is no stranger to the citizens of eastern Missouri. He has strong roots in the city of St. Louis, having graduated from the University of St. Louis School of Law and having served in the city's Office of the Circuit Attorney, where he prosecuted a variety of criminal cases and later acted as the First Assistant Circuit Attorney. He also served on the Rape Trial Task Force and created the first child abuse unit in the Office of the Circuit Attorney. From 1991 to 1997 he served as Adjunct Professor of Law at St. Louis University School of Law. Judge Autrey's prosecutorial excellence attracted the attention of both Republican Governor John Ashcoft, who appointed him as an Associate Circuit Judge on the Circuit Court of the City of St. Louis in 1986, and Democratic Governor Mel Carnahan, who elevated him to Circuit Court Judge in 1997. Judge Autrey's judicial experience on the State bench will serve him well in the district court. Judge Autrey is described by associates as a judge who ``work[s] very hard to ensure that justice is provided to all'' and as a ``smart and hard-working jurist.'' He merited an ABA rating of ``Unanimous Qualified,'' and I fully expect him to serve with distinction on the Federal bench in Missouri.

Mr. HATCH

Mr. HATCH. Mr. President, I stand in support of the confirmation of D. Brooks Smith, who has been nominated to be a judge on the Third Circuit Court of Appeals. Judge Smith is currently the Chief Judge for the Western District of Pennsylvania. He has compiled an impressive record as a judge since 1988, when, at age 36, he became one of the youngest Federal judges in the country. Prior to that, Judge Smith has served as a state court judge, as a prosecutor, and as a private practitioner with a law firm in Altoona, Pennsylvania. He is a 1973 graduate of Franklin and Marshall College and a 1976 graduate of the Dickinson School of Law in Pennsylvania. Of course, anyone who has been reading the newspapers in the past few months knows that it would be impossible to comment on Judge Smith's credentials without mentioning the attack he has come under from the usual liberal lobbyist interest groups in Washington. As President Reagan would say, there they go again. An editorial in Pittsburgh Post-Gazette noted, Critics of Smith, many aligned with Democratic Party interests, say he has been too quick to dismiss valid lawsuits brought by individuals against corporations, and too eager to travel to conferences paid for by businesses with interests in federal litigation. . . . But outside Washington's world of partisan poliitics, Smith seems to have no enemies, only admirers. Those who have watched him work say an exemplary 14-year record on the federal bench in Western Pennsylvania is being twisted by political opportunities. His popularity outside the capital extends even to members of the opposing political party, who describe him as fair, hard-working and respectful to all. Well, it is an election year and we know the left of mainstream groups will not miss an opportunity to flex their muscles. Those groups who are working to discredit Judge Smith apparently believe that President Bush's circuit court nominees deserve to have their records distorted and their reputations dragged through the mud. I think that no judicial nominee deserves such treatment, and that was something I practiced as Chairman for 6 of President Clinton's 8 years in office. I strongly agree with the Washington Post editorial of February 19, 2002, that ``opposing a nominee should not mean destroying him.'' Referring to our last confirmation hearing, the Post pointed out. The need on the part of liberal groups and Democratic senators to portray [a nominee] as a Neanderthal--all the while denying they are doing so--in order to justify voting him down is the latest example of the degradation of the confirmation process. I hope that my colleagues in the Senate will be sensitive to the dangers to the judiciary and to the reputation of this body that will certainly result from the repeated practice of degrading honorable and accomplished people who are willing to put their talents to work in the public service. Again, I fully support a thorough and genuine review of a nominee's record and temperament, and in no way do I think we should shy away from our constitutional role of providing advice and consent. We did that in the case of D. Brooks Smith and have found him to be one of the finist jurists serving today. The President was right to nominate him, we will do well to confirm him.

Mr. HATCH

Mr. HATCH. Mr. President, I rise to speak again on the pending legislation--S. 812--the Greater Access to Pharmaceuticals Act. First, let me say that I am hopeful the on-going talks among interested Senators and affected parties will succeed in reaching an acceptable compromise on a Medicare Prescription Drug Benefit. That is a promise to seniors we need to honor. I remain committed to achieving that goal. I think that Senator Snowe made a good point when she said earlier today that there is no reason to pull the bill down and halt the negotiations over the Medicare drug benefit at his point. Why not encourage these talks to continue over the August recess? Although we got off to a rocky start when the Majority Leader decided to by-pass the Finance Committee to avoid the Tripartisan bill being reported by the Committee, I remain hopeful that we can come together if we stick to it. Whether those talks succeed or fail, the Senate will have to dispose of the underlying legislation, S. 812. This is the legislation first introduced by Senators McCain and Schumer that was almost completely rewritten by the HELP Committee via the Edwards-Collins substitute amendment. In many respects, the Committee substitute is an improvement over the McCain-Schumer language. Let me hasten to say, though, there are still major problems with the language. I have laid out in some detail the shortcomings in the provisions of the bill that purport to fix the problems associated with the statutory 30-month stay. We designed this stay to permit a reasonable period of time to litigate the status of pioneer drug patents, but has been used in several cases by brand name drug manufacturers to forestall improperly generic competition. As this barely three-weeks old language is scrutinized by experts, many are concluding that it comes up short. For example, there is an interesting and growing correspondence between the architect of the pending legislation, my friend from Massachusetts, Senator Kennedy, and the organization that represents the Nation's biotechnology companies-- BIO, the Biotechnology Industry Organization. In its letter of July 22, 2002 to Senator Kennedy, BIO complains about the: carte blanche authority of FDA to determine testing methods applicable to full NDAs, [New Drug Applications] loss of the ability to protect our intellectual property because of failure to meet new filing deadlines under food and drug law, and an unwarranted private right of action afforded generic companies to sue members in efforts to ``delist'' patents or ``correct'' patent information. Whatever the purposes of these provisions, we fundamentally disagree with their consequences perhaps the result of producing totally new provisions only 36 hours before mark-up. Actually, I think this completely new language was not available until 24-hours before the markup. It is also my information that a meeting last Friday between Senator Kennedy's staff and BIO staff did little to clear up these objections. I have no doubt that Senator Kennedy is aware this bill is opposed by the Massachusetts-based biotech firm, Millennium Pharmaceuticals, as well as the Massachusetts Biotechnology Industry Organization. As I have laid out previously, in addition to the policy question of the extent to which these new provisions upset the balance of Hatch- Waxman, a broad spectrum of legal analysts who range from Susan Estrich to Judge Bork have raised a number of concerns about the pending legislation on a wide variety of issues, including concerns that the bill runs afoul of the Takings Clause as well as violates the GATT Treaty's intellectual property provisions. Last week, I included in the Record a letter from the American Intellectual Property Law Association opposing the patent forfeiture and private right of action provisions of the bill. This week I want to highlight a letter to Chairman Kennedy from the Intellectual Property Owners Association expressing severe reservations about the bill. The IPO represents U.S.-based owners of patents, trademarks, copyrights, and trade secrets. The organization includes some 100 American firms that are among the largest patent filers in the United States. The membership of the Intellectual Property Owners Association submit about 30 percent of all patents filed with the Patent and Trademark Office. The IPO letter raises concerns about how the Substitute to S. 812 might conflict with the international Agreement on Trade Related Aspects of Intellectual Property Rights--the TRIPS provisions. Specifically, the IPO complains about the file-it-or-lose-it and sue- on-it-or-lose-it provisions of the bill. The letter states, in part: We believe these rigid barriers to enforcement of patent rights may conflict with ``normal exploitation of patent rights'' as that term is used in Article 30 of the TRIPS agreement, or could set a very damaging precedent for interpretation of Article 30 that would be used against the U.S. by its trading partners in other areas of intellectual property enforcement. The new, untested, Edwards-Collins language has not been embraced by the intellectual property bar nor by the mainstream organizations that represent the interests of America's inventors. The Administration has already issued a statement in opposition to S. 812. Before we take any action to adopt the language that has agitated nearly everyone in the IP community, don't you think it would be prudent to factor in what the Patent and Trademark Office has to say about this new language that completely re-wrote the McCain-Schumer bill? Commissioner James Rogan wrote to me today to give us PTO's initial reactions to re-write of S.812. Here is part of what the Commissioner of Patents and Trademarks says in his letter to me: USPTO does recognize that some changes to current law may be necessary to encourage appropriate access to generic substitutes and prevent abuses of the patent laws. But S. 812 clearly is not the answer. In fact, this bill would likely do the opposite of what its title suggests by limiting access to cutting-edge drugs, decreasing innovation, and ultimately harming the quality of treatments available to patients. In addition to these significant concerns raised by the PTO, I would think that the report that was issued earlier today by the Federal Trade Commission, after a unanimous vote of the Commissioners, would compel my colleagues in the Senate to question the wisdom of adopting the HELP substitute to S. 812. While I am still studying the details of the report, it seems abundantly clear that the major recommendations of the Federal Trade Commission in no way mirror the legislation pending on the floor. With respect to the 30-month stay, the FTC suggests a policy of one stay per generic drug application for all patents listed in the official FDA Orange Book prior to the date on which the generic drug application is filed. This is precisely the position I advocated before the HELP Committee back in May. This is the position that the Ranking Republican Member of the HELP Committee, Senator Gregg, attempted to get adopted by the HELP Committee during the mark-up. The narrowly-tailored FTC recommendation in this area should be contrasted with the overly-broad Edwards-Collins language that contains the offensive file-it-or-lose-it and sue- on-it-or-lose-it provisions, the new and unprecedented--and unnecessary--private right of action in the Federal Food, Drug, and Cosmetic Act, as well as the rule that allows the 30-month stay only for those patents issued within 30-days of the approval of the pioneer drug. I know which policy I prefer--and it came from the FTC after its comprehensive year-and-a-half study of these issues, not from any secret backroom drafting sessions of various lawyers and lobbyists. Let me now focus my comments on another major area addressed by the HELP Committee substitute to S. 812: the problem of collusion between brand name and generic drug manufacturers with respect to the rules in current law that grant 180-days of marketing exclusivity when a generic drug firm successfully challenges or navigates around a pioneer firm's drug patents. The 180-day marketing exclusivity rule has been highly controversial in recent years. The reason for this attention is simple. In a few number of documented cases, generic drug manufacturers entered into agreements with brand name manufacturers not to sell generic drugs. As I will explain, due to the way the existing law--the Drug Price Competition and Patent Term Restoration Act of 1984--is written and has been interpreted by the courts, some of these arrangements had the effect of delaying multi-source generic competition well beyond the contemplated 180-days. I should first note that the existing statute--the Waxman-Hatch Act-- included this 180-day marketing exclusivity as an incentive to encourage patent challenges. If patents were found to be invalid, or if non-infringing ways to produce generic drugs were developed, consumers could benefit from the earlier-than-anticipated introduction of generic drugs into the marketplace. In enacting these provisions, it was the intent of Congress to award this exclusivity only to a generic drug applicant that was successful in defeating a pioneer firm's patents. FDA's 1994 regulations implementing the Hatch-Waxman Act required the generic drug challenger to defend successfully the lawsuit that a pioneer firm must initiate within 45-days after being notified that the generic firm was challenging the patent. It must be emphasized that the reason the generic drug firm is the plaintiff in the suit, rather than the defendant, is that the statute contains a special protection allowing generic firms to conduct what would normally be infringing activities in order to secure FDA regulatory approval. This is the so-called Bolar Amendment, a provision of law that, in my opinion, has not been adequately recognized by the proponents of S. 812. Essentially, the Bolar language trumps the general rule against patent infringement codified in section 271(a) of the patent code. The Bolar Amendment, codified in section 271(e) of the patent code, allows generic drug firm to infringe patents in order to win FDA approval and gear up production and creates an artificial act of patent infringement at the moment that the generic firm files an abbreviated new drug application with the FDA. Once the application is filed, the pioneer firm has 45-days to file a lawsuit in order to take advantage of the statutory 30-month stay designed to allow the patent litigation to be completed before generic may be permitted to enter the marketplace. For over a decade after Hatch-Waxman was enacted in 1984, it was thought that only a generic firm that was successful in the litigation, that is, a firm that had successfully defended the suit brought by the pioneer firm, could qualify for the 180-days of marketing exclusivity. In 1997, FDA's successful defense requirement was struck down by the D.C. Circuit Court of Appeals in the case of Mova Pharma v. Shalala. The following year, in 1998, the D.C. Circuit decided the case of Purepac Pharm v. Shalala. This decision upheld FDA's new system of granting the 180-day exclusivity to the first filer of a generic drug application even if the pioneer firm did not sue for patent infringement. That same year, the Fourth Circuit Court of Appeals issued its opinion in Granutec v. Shalala. This case held that the exclusivity of the first filer could be triggered by a court decision with respect to a second, third, or subsequent filer. Essentially, these decisions added up to one thing: mischief. Once the exclusivity was awarded to the first filer of a generic drug application divorced from any requirement for a successful patent challenge, it became apparent to some that the first filer--with a financial inducement from the patent holder--could effectively forestall multi-firm generic competition by simply not going to market. If the 180-day clock never started, multi-source generic competition could be forestalled until the patents expired. This could last for years. As a coauthor of the Drug Price Competition and Patent Term Restoration Act, I can tell you that I find these type of reverse payment collusive arrangements appalling. I must concede, as a drafter of the law, that we came up short in our draftsmanship. We did not wish to encourage situations where payments were made to generic firms not to sell generic drugs and not to allow multi-source generic competition. To date, there are known to have been relatively few such agreements. The FTC has obtained consent decrees in two cases: with Hoescht and Andrx over the drug, Cardizem, and with Abbott and Geneva over the drug, Hytrin. The agency suffered a set-back recently in the third case it brought in this area which involved an agreement between Schering-Plough, Upsher-Smith, and American Home Products with respect to the compound K-Dur 20, a widely prescribed potassium chloride supplement. While the FTC settled with American Home products, an Administrative Law Judge recently rejected the agency's argument in the case against Schering and Upsher-Smith. The ALJ's opinion looked at the facts of competition in the potassium chloride market and concluded that FTC had not proven its case given the highly-competitive nature of this particular market. However the K-Dur case ultimately is decided, I commend FTC Chairman Tim Muris for indicating he will continue the agency's policy of zealously reviewing these type of reverse payments cases to determine whether such agreements run afoul of the antitrust laws. In my earlier statements, I commended both the enforcement actions of the FTC and the development of the Drug Competition Act, S.754, by Senator Leahy for creating a climate unfriendly to the execution of any additional collusive deals not to compete between generic and brand name companies. Today's release of the report: Generic Drug Entry Prior to Patent Expiration: An FTC Study underscores the importance of Senator Leahy's work in developing the Drug Competition Act. This bill was reported by the Judiciary Committee last year. I was pleased to work with him to refine the bill before the Committee adopted this measure. I am particularly pleased that he became convinced it was wise to abandon a patent forfeiture feature very similar to the provisions contained in the Edwards-Collins substitute to S. 812 that so many biotech and pharmaceutical firms and intellectual property experts find so objectionable. I did have a few additional suggestions for improving S. 754, but in the interest of moving the legislation forward in a bipartisan fashion, I supported the bill in Committee. Frankly, one of my suggestions is very simple and amounts to recognition of the importance of the bill. This simple suggestion would be to codify the bill as part of the Clayton Act, rather than let the language float as a statute-at-large. Here are the other concerns that I have with S. 754. The Leahy bill exempts three types of agreements: first, purchase orders for raw material supplies; second, equipment and facility contracts; and third, employment or consulting contracts. These three categories were also exempted by the FTC in its recently completed study of the pharmaceutical industry. To these three, I would suggest adding two other classes of non-germane agreements: first, packaging and labeling agreements and, second, confidentiality agreements. It seems to me that the thrust of the legislation is to get a quick review of actual executed agreements relating to settlements of patent non-infringement or patent invalidity cases arising out of Hatch-Waxman Paragraph IV certifications. Garden variety packaging and licensing agreements or mere agreements to talk about possible settlements in a confidential manner are not what we are after with this legislation. I think we should start with the presumption that the law will be followed. Given this perspective, I favor the total deletion of proposed Section 8, subsection (b) which creates a special rule for contract unenforceability. My understanding is that this is a relative recent addition to the Leahy bill and that only current sections 8(a) and 8(c) were in the original Leahy bill and, in fact, precisely mirror the long-standing Hart-Scott-Rodino enforcement language. In short, what does this new section 8(b) accomplish that is not included in the more general provision of section 8(c) that grants a broad authority for equitable relief? And what is the real chance that one or both parties will not comply with the statute in the first place? And if one party reports, what could possibly be gained by the other party not reporting the agreement? For that matter, it might be preferable to change the bill to require a joint submission of a certified copy of the agreement because one can hardly imagine some poor FTC staff attorney doing a side-by-side, word-by-word reading of documents to make sure both parties sent the same agreement. In addition, I think that language should be added to make explicit that nothing in this Act should be construed to discourage or prohibit legitimate settlements between brand name and generic drug companies. The Joint DOJ/FTC guidelines smile upon such settlements so long as they do not run afoul of other laws such as the antitrust statutes. The FTC Administrative Law Judge's decision in the K-Dur 20 case reminds us of this fact, no matter how the case is finally decided. The essence of S. 754 is to see that every agreement between pioneer and generic firms that raises antitrust questions are promptly reported to the FTC and DOJ for appropriate scrutiny. I think the emergence of the Leahy bill--and I must give credit as well to the McCain-Schumer bill, coupled with the strict FTC enforcement in this area and the agency's extensive industry-wide survey helps explain why these so-called reverse payment cases appear to be dwindling, and perhaps have completely halted for the time being. Senator Leahy should be pleased that the chief recommendation that the FTC is making today with respect to the collusive 180-day marketing exclusivity agreements amounts to an endorsement of S. 754. The FTC report recommends that Congress: Pass legislation to require brand-name companies and first generic applicants to provide copies of certain agreements to the Federal Trade Commission. This straight-forward recommendation is a far cry from the complex, barely comprehensible, 180-day marketing exclusivity fix that emerged from the HELP Committee. As a Wall Street Journal article yesterday described the discussion of the Edwards-Collins substitute: ``In a remarkable session, it became clear that many lawmakers didn't understand the complex bill.'' Why should that be surprising given the fact that this completely new, incredibly- intricate, highly-technical language was made available the day before the mark-up? A review of proceedings of the two-day HELP Committee mark-up is very revealing and I would urge that the press and the public make the effort to review this discussion. I can see why Senators Gregg and Frist are so frustrated about some changes in language that appear to have been agreed to one moment, only to vanish the next. One can only wonder who, how, where, when, and why such language was drafted--although yesterday's Wall Street Journal article may shed some light on some of the actors behind the scenes. In many ways, the Edwards-Collins substitute misses the mark, and is too complicated to boot. Nevertheless, I do think we need to re-examine the statute in this area in light of the potential for these type--or perhaps new types of--anticompetitive agreements to crop up in the future given how the current statutory language and court decisions work together to help create a climate for mischief. The McCain-Schumer bill addressed the 180-day collusive reverse payments situation by a so-called rolling exclusivity policy. This rolling exclusivity means that if the eligible generic drug filer does not go to market within a specified time period, the 180-day exclusivity rolls to the next filer. I do not favor rolling exclusivity. I agree with what Gary Buehler, then Acting Director of FDA's Office of Generic Drugs, told the Judiciary Committee last year: We believe that rolling exclusivity would actually be an impediment to generic competition in that the exclusivity would continue to bounce from the first to the second to the third if, somehow or other, the first was disqualified. I believe a better course of action was advanced by FDA in its 1999 proposed rule which suggested a use it or lose it policy. This simple rule is that if the first eligible generic drug applicant did not promptly go to market, all other approved applicants could commence sales. Molly Boast, Director of the FTC Bureau of Competition, testified last May that, at the staff level, FTC supported FDA's use it or lose it proposal. My first reading of the summary of the new FTC Report leads me to conclude that the agency favors a very aggressive use it or lose it policy. In this regard I must point out that the FTC Report contains three minor recommendations that center on the 180-day provision: First, the agency would run the 180-day clock if a generic firm marketed the pioneer's product under a license, not an ANDA. Second, FTC would codify current case law and run the 180-day clock from the time of any court decision, not an appellate decision as allowed under the HELP Committee language. Third, the Commission would trigger the 180-days if a court dismissed a declaratory judgment for lack of case or controversy. While I am just beginning my review of the FTC report, it appears that the FTC is advocating a very aggressive form of a use-it-or-lose- it policy. As I have argued on a number of occasions, my view is that rolling exclusivity delays the day when multi-generic competition can commence. It appears to me that the FTC shares this view. If our goal is to maximize consumer savings after a patent has been defeated, I find it difficult to see how rolling exclusivity achieves this goal. I certainly prefer a use it or lose it approach over the McCain-Schumer brand of rolling exclusivity. I commend the sponsors of the Edwards-Collins substitute for rejecting the McCain-Schumer rolling exclusivity policy in favor of what Senator Edwards calls modified use-it-or-lose-it. Having said that, I am disturbed to learn that during the HELP Committee mark-up Senator Edwards and HELP Committee staff stated that, in fact, the exclusivity could roll indefinitely. I understand the intent is to transfer the exclusivity once and only once, but having reviewed the language of the bill and the discussion at the mark-up, I am not convinced that the exclusivity will roll over only once. In any event, even if the exclusivity only rolled over once, I question the rationale behind a policy that only delays the day when multi-source generic competition can commence. It is only after the time when many generics enter the market that consumers receive the full benefits of price competition. During the first 180-days when only one generic is on the market, the change in price may be marginal. This is so because when there is only one generic competitor during this 180-day time frame, neither the pioneer firm nor the generic firm is under any tremendous pressure to cut the price. The report, Drug Trend: 2001, published by Express Scripts, notes this dynamic: The A.P. [average wholesale price] for the first generic is usually about 10 percent below the brand. After the six month exclusivity granted to the first generic manufacturer, the price paid . . . for the generic quickly falls, often by 40 percent or more, as multiple manufacturers of the same generic product compete for market share. Moreover, it appears that the value of the 180-day marketing exclusivity incentive may be worth much more today that it was back in 1984. I understand that, in 1984, the number-one selling drug in the United States was Tagamet, with U.S. sales of about $500 million. Today, it is estimated that Lipitor, the anti-cholesterol medicine, has a domestic market of over $5 billion annually. In nominal dollars, Lipitor sales today are 10-times higher than Tagamet sales were in 1984. In real dollars, I am told that this amounts to about a six-fold increase. If we are going to open up the 180-day provisions of the 1984 law-- and I think we should so long as we do it carefully and thoughtfully--I think we should reexamine other aspects of the 180-day rule such as whether we should retain the 180-days or some other number of days given the substantial six-fold growth in potential value of this incentive. Why should we be locked into 180-days? The dirty little secret of the 180-day provision is that both the pioneer firms and generic firms like this provision because it delays the full price competition that only occurs when many generic enter the market. I think that the mutual economic interest of the generic and the pioneer firms is not in perfect alignment with the interests of consumers with respect to the 180-day incentive. Moreover, even if we could perfect the modified use it or lose it language of the Edwards-Collins substitute and the first qualified generic manufacturer could not, or would not, commence marketing and the exclusivity moved to the next qualified applicant, why should the second manufacturer get the full 180-days? Why not 90 days? Why not 60 days? Frankly, I am disturbed that, in some circumstances, the Edwards- Collins language appears to grant exclusivity not to the successful generic litigant--but to a firm which was merely first to file papers with the FDA that triggered a legal proceeding. I understand the rationale for this is that it will supposedly ensure multiple patent challenges. But, when we start rewarding the first to trigger lawsuits in place of actually winning the challenge, it strikes me as out of sync with the traditional American value of rewarding the actual winner. I am all for assuring that there are sufficient incentives to ensure patent challenges. But, isn't there a limit beyond which we should direct these potentially enormous profits back to consumers? While I have not seen any formal estimates, one would think that 180- days of marketing exclusivity for a $5 billion seller like Lipitor must mean hundreds of millions of dollars, and perhaps even $1 billion, in lost consumer savings. Would we rather see 25 percent to 40 percent of that money in the hands of the trial attorneys who brought the case? Or, would we rather see that at least some of those funds earmarked for attorneys' fees be channeled to help citizens lacking access to prescription drugs? Shouldn't we get more facts concerning the change in value of the 180-day marketing exclusivity today compared to 1984 and make any appropriate adjustment to this incentive? We don't want to set the incentive so low as to discourage challenges to non-blockbuster patents, but we don't want to set the incentives too high either. As a matter of fact, some have questioned the need for retaining the 180-day marketing exclusivity at all. For example, Liz Dickinson, FDA's senior, career attorney in this area, has asked: I suggest we look at whether 180-day exclusivity is even necessary, and I know that there is this idea that it is an incentive to take the risk. I say the facts speak otherwise. If you have a second, third, fourth, fifth generic in line for the same blockbuster drug . . . undertaking the risk of litigation without the hope of exclusivity, is that exclusivity even necessary? Ms. Dickinson, a fine lawyer with no political axe to grind, went on to make the following observation with respect to the 180-day rule, We have got a provision that is supposed to encourage competition by delaying competition. It has got a built in contradiction, and that contradiction . . . is bringing down part of the statute. Similarly, Gary Buehler, FDA's top official in the Office of Generic Drugs agreed with his colleague's assessment when he testified before the Senate Judiciary Committee last year: . . . we often have the second, third, fourth, fifth challengers to the same patent, oftentimes when the challengers actually realize that they are not the first and there is no hope for them to get the 180-day exclusivity. So with that in mind, I would agree with Liz's statement that generic firms will continue to challenge patents. Whether the 180-day exclusivity is a necessary reward for that challenge is unknown, but it does not appear that it is. I personally favor retaining some incentive to ensure vigorous patent challenges. But in light of this testimony and other factors, I do not believe there is a need to be locked into the current incentive--the 180-day exclusivity benefit. I find it curious that neither the McCain-Schumer bill, nor the Kennedy mark, nor the Edwards-Collins amendment, proposed any changes in the current 180-day regime in light of the views of the FDA officials, the dramatic increase of the potential value of 180-days of exclusivity, and other factors. This may have been partly due to the fact that neither the FDA nor FTC nor any representatives from the Administration testified at the HELP Committee hearing on May 8th. In fact, no committee of Congress has ever held a hearing of the language that was marked-up and reported by the HELP Committee. On any number of occasions, I have heard Senator Schumer and others argue that the simple goal of this legislation is to close loopholes in order to return to the original balance in the 1984 law. But what if conditions have changed and the original policies of the 1984 need to be reassessed? Or what if there were an area that we didn't get right the first time? For example, consider how Paragraph IV litigation treats patent invalidity and patent non-infringement challenges. These are lumped together, and both, if proven, can result in identical 180-day marketing exclusivity awards. In truth, invalidity and non-infringement are two very different types of claims. I want to remind my colleagues of, and challenge them to question the implications of, lumping these two concepts together. We need to re- think this policy. As Al Engelberg, a smart and tough-as-nails attorney who specialized in attacking drug patents on behalf of generic drug firm clients, has said about this difference: In cases involving an assertion of non-infringement, an adjudication in favor of one challenger is of no immediate benefit to any other challenger and does not lead to multi- source competition. Each case involving non-infringement is decided on the specific facts related to that challenger's product and provides no direct benefit to any other challenger. In contrast, a judgment of patent invalidity or enforceability creates an estoppel against any subsequent attempt to enforce the patent against any party. The drafters of the 180-day exclusivity provision failed to consider this important distinction. Once again, as one of the drafters of this law, I accept my share of responsibility for failing to fully appreciate the implications of this distinction. The 180-day rule acts as only a floor in non-infringement cases. A particular non-infringer's marketing exclusivity can extend beyond the statutory 180-days. This period of marketing exclusivity can last until such time as another non-infringer might enter the picture or until the underlying patents are invalidated or expire. Conversely, it can be argued that the 180-day floor actually works to the detriment of consumers whenever the 180-days of exclusivity acts to block entry of a second non-infringing generic product during the 180- day period. Why shouldn't a second or third non-infringer be granted immediate access to the market as would occur in any other industry? Consumers could enjoy the savings that accrue from immediate price competition. I would hope that my colleagues working on the bill, and others interested in this debate carefully consider the distinctions between invalidity and non-infringement challenges. This is an area where we might have gone off-base in 1984. While I am of the mind to retain a strong financial incentive to encourage vigorous patent challenges by generic drug firms, I am unconvinced at this point that we should retain the old language that grants identical rewards for successful invalidity and non-infringement claims. I welcome debate and discussion on this matter. Before we change the law, let us have a serious re-examination of whether to retain the 180-day marketing exclusivity in its current form both in terms of the length of the exclusivity period and whether the rewards for successful invalidity and non-infringement challenges should be treated identically. My purpose in raising these points is to get an indication from the sponsors of this legislation and other interested parties, such as patient advocacy organizations, state Medicaid agencies, and insurers, whether there is interest in discussing the advisability of passing on more of the value associated with the current 180-day marketing exclusivity to consumers if it appears it is fair and appropriate to do so? If there is interest, I would be willing to help fashion an appropriate amendment. It seems to me that we need to provide enough of an incentive to assure vigorous patent challenges, but we should give away no more exclusivity than is necessary. Every day of marketing exclusivity awarded to a generic firm comes at the expense of consumers. While we want to ensure vigorous patent challenges, we don't want to set the benefit too high at the expense of consumers. I think we can and should explore this area further. Frankly, I am not certain that I completely understand how the forfeiture language in Section 5 of the bill works. I do not think I am alone in this confusion. I understand that this language was the source of much confusion during the mark-up in the HELP Committee. At some point, I would like to engage in a colloquy with the bill managers to ask some questions designed to clarify precisely how this provision works. Let me say that if the bill reinstates the successful defense requirement and gives awards to the successful challenger so long as the firm goes to market in a timely fashion, I may be supportive of the general concept. I do wonder if the language in the HELP substitute overturns the effect of the MOVA, Purepac, and Granutec cases that I described earlier? I must say that I think that there are some real advantages to Senator Gregg's simple and straight-forward policy of more closely following FDA's old-fashioned, easy to understand use-it-or-lose-it proposal. I will continue to study the particulars of the three minor recommendations that the FTC has made in connection to the 180-day issue. I must also indicate that part of the confusion concerning the effect of this new Edwards-Collins language stems from the discussion of the provision at the mark-up. I understand that when Senator Edwards first explained this section of the bill he said that the exclusivity could roll over one time if the first qualified applicant did not use it. I am told that Senator Edwards indicated his language would eliminate the possibility that this could just continue to roll over and over and over during which time the exclusivity in the marketplace continues. However, upon questioning from Senators Gregg, Frist, and Sessions, the Committee staff then explained that if the second generic firm qualified does not use the exclusivity then the process would start all over again. The HELP Committee staff went on to explain, apparently in direct contradiction to Senator Edward's first explanation, that the exclusivity could roll indefinitely if there is no generic ready to go to market. On the second day of the mark-up, Senator Edwards seemed to indicate that the Committee staff had it right and he had it wrong when he at first said that the provisions of Section 5 of the bill eliminated the policy of rolling exclusivity. In fact, I am told that Senator Edwards then acknowledged that if there were nobody to compete, then the exclusivity could keep rolling over and over. I am afraid that the Edwards-Collins brand of modified-use-it-or- lose-it is, at least, very confusing. At worst, it is just another version of rolling exclusivity. I want to learn what the FTC thinks about the Edwards-Collins language. What the proponents of this language have failed to do is to explain why any third, fourth, fifth, or subsequent filer should be given 180- day of very valuable marketing exclusivity? Moreover, why for example should a fifth filer be treated any differently than a sixth filer if neither has won a patent challenge and both are ready to go to market? This dog just won't hunt. Recall that some experts at FDA don't even think this incentive is necessary. As I stated earlier, I am somewhat sympathetic to the concerns of generic drug firms that any exclusivity awarded should be measured from the time of an appellate court decision. But this principle may not hold up if any form of rolling exclusivity is adopted or if we have multiple patents and multiple challengers, some of whom are attacking on invalidity and some of whom are attacking on non-infringement. Frankly, in light of the FTC report just issued this morning, I feel compelled to reconsider if my sympathies are consistent with my use-it- or-lose-it view even in the case, increasingly rare, I am told, of one patent and one challenger. I am troubled by the provision of the bill that appears to grant each generic firm that qualifies for the benefit of the 180-day marketing exclusivity incentive a 30-month period to secure FDA approval. This is measured from the time of the filing of the generic drug application. If the first firm eligible to take advantage of the 180-day benefit drops out for some reason, it seems to me that the best thing for consumers would be to approve all applications that are ready to go without singling out any of these applications for 180-days of exclusivity. If, for example, the second firm eligible under the terms of Section 5 is in a dispute with FDA over a good manufacturing practice inspection and can't go to market, it is consumers who will suffer. In a case where, say, there are 14-months remaining on the 30- month clock allowed under Edwards-Collins, it does not seem fair if the next firm eligible on the list already has satisfied all of the FDA requirements and is ready to go to market. I would hope that the proponents of the substitute amendment will help us all understand just how Section 5 is intended to work. It is difficult for me to see why we should adopt a policy whereby the balance of the 30-month period described in Section 5(a)(2)``(D)(i)(III)(dd)'' on page 44 of the bill could conceivably be greater than the 180-days of marketing exclusivity. Upon default of the first qualified applicant, why should we wait for a second eligible drug firm to obtain FDA approval when there may be a third, fourth, or fifth applicant in line with FDA approval ready to go? I hope the sponsors of the legislation are not locked into their so- called modified-use-it-or-lose-it policy. The discussion at the HELP Committee mark-up suggests that the language is, in fact, just another elaborate version of the flawed rolling exclusivity policy. While I can readily see why rolling exclusivity is attractive to generic drugs firms--and their lawyers--who routinely challenge patents, I don't see where this policy is good for the American people. Whatever happened to the American tradition that rewards success in litigation, not just filing papers with FDA and making a claim in court? For all of the reasons I have just discussed, I think it would be wise for Congress to take time and reassess the wisdom of retaining the 180-day marketing exclusivity provision in essentially the same form as enacted in 1984. As I argued last night, the Senate would be well-served if we had a more orderly discussion of the facts and recommendations contained in the new FTC study. I see that my friend from Massachusetts is trying to spin the FTC study as supporting the changes in patent law contained in the HELP Committee substitute. But the fact is, and it is a fact that will be better understood over time, that the FTC recommendations are at variance with the major provisions of the bill on the floor. Let me just spell some of them out for you. The FTC urges adoption of legislation that would allow one 30-month stay, measured from the time that each generic drug application is submitted while S. 812 limits the stay to those patents issued within 30-days of the approval of the pioneer drug. The HELP Committee Substitute contains several provisions that require innovator firms to list all, and sue on, their patents related to each particular pioneer drug or forfeit their customary patent rights; the FTC makes no such recommendations regarding patent forfeiture. The HELP Committee Substitute creates a new private right of action to attack the listing of patents with FDA, while the FTC report makes no such recommendation. The HELP Committee Substitute embraces a form of 180-day marketing exclusivity that allows the exclusivity to roll from one generic drug manufacturer to another in, I might add, a very complicated fashion that potentially has no clear endpoint. The FTC Report appears to support a very aggressive form of a use-it-or-lose-it policy which, for example, would trigger the 180-day period from the time of a district court decision. The pending legislation allows generic competition to be delayed until after an appellate court rules. The FTC recommends that certain potentially anti-competitive arrangements between pioneer and generic firms be reported to the FTC in a fashion similar to Senator Leahy's legislation, S. 754, the Drug Competition Act. The HELP Committee is silent in this respect. So the differences are significant between the bill on the floor and what the FTC recommends. No amount of spinning in the press will change these facts. In light of the FTC study and some of the arguments that I have made here today, I wonder if some of those who are backing S. 812 because they were told it is a good bill will now reconsider what the bill does and decide that they are being sold something of a bill of goods? I would urge my colleagues, as well as consumer organizations and pharmaceutical purchasers such as insurers and self-insured businesses to reflect upon what I have said on this subject today. This is an area in which I think we would be wise to reject Senator Schumer's argument that all we are doing with this legislation is restoring the balance of the old Hatch-Waxman Act. On a number of occasions, I have commended Senator Schumer and Senator McCain for moving their legislation forward. Even if the bill that came out of the HELP Committee does not resemble very closely their bill, and even if I still have major problems with this hastily considered floor vehicle, I commend them again today. I just hope that they, and Senators Kennedy, Frist, Collins, and Edwards will work to improve this legislation. I think that over the last two weeks that I have made a case for taking the time to get this legislation right. We all know that S. 812 was plucked from the calendar to be used as a vehicle to debate the Medicare Prescription Drug Benefit, not because it was some finely tuned consensus bill. As I said last night, let us not rush to adopt legislation in this area before the ink is dry on the FTC report. We need to understand and debate the FTC report and its recommendations. My first reading of the Executive Summary of the FTC Study reveals a fundamental disconnect between the agency's recommendations and the legislation that emanated from the HELP Committee. The floor of the Senate is not the best place for the type of discussion the FTC Report warrants. We need to allow the Judiciary Committee to play a role in fashioning legislation that is fundamentally an anti-trust bill with patent law and civil justice reform implications. Certainly, the FTC smiled upon what the Judiciary Committee was doing in this area. And just as certainly, the PTO did not smile upon how the substitute to S.812 treats longstanding patent rights. The detailed criticism that I have made to the pending bill in no way minimizes the importance of the matters that are the subject of the pending legislation, because they deserve Congressional attention. Let me be clear. We should make some changes in the Hatch-Waxman Act. No law so complex cannot be improved. But let's do it the right way because the American public deserves both the newest medicines and the most affordable medicines. I do not believe, moreover, that S. 812 even identifies the most important issues we should address in Hatch-Waxman reform. I hope to return to the floor to discuss some ideas for a more comprehensive approach to reforming the Drug Price Competition and Patent Term Restoration Act. I suspect that many others, including my friend, Henry Waxman, will want to participate in such a discussion. I am unconvinced that focusing on how best to bring the law back to the old days of 1984 is the right way to go about reforming the Hatch- Waxman Act. I think we may be well served if we attempt to modify the law in order to help usher in a new era of drug discovery while, at the same time, increasing patient access to the latest medicines. Let us not adopt this hastily-crafted bill in the last week before August recess. Please do not hold your nose and close your eyes and vote for this bill by telling yourself that we can fix it in conference. We can do better. We would do better in the long run for the American people if we put S. 812 aside for the time being and devote our attention to passing the Omnibus Trade Promotion Authority, Trade Adjustment Assistance, and Andean Pact legislation before this week runs out. We need to get the economy going again and trade can help us achieve that goal. Let's face it. S. 812 is not ready for adoption, but the trade legislation is long overdue. I ask unanimous consent that the letters from the PTO and BIO, discussed earlier in my speech, be made part of the Record.

Mr. HATCH

Mr. HATCH. Mr. President, I ask unanimous consent that I be allowed to speak as in morning business.

Mr. HATCH. I suggest the absence of a quorum.

Mr. HATCH. Mr. President, hearing my colleague, one might forget that this is the U.S. Senate rather than some whacky politically correct college campus--Berkeley on the Potomac. The fact is, this judge is one of the most respected judges in all of Pennsylvania. He has virtually everybody in western Pennsylvania on his side. He has served 14 years on the Federal bench and has done a very good job in doing so. He is highly respected and has the highest rating from the American Bar Association--the gold standard, according to our colleagues from the other side. And he did not break his word. The fact is, the law was different than was explained to him when he appeared before the committee, and it is still different than the distinguished Senator from Vermont has been making out here today. I often hear my colleagues talk about the Clinton nominees who were left at the end of the 106th Congress, but I rarely hear them mention the 54 nominees who were left at the end of the Democratic-controlled 102nd Congress when George Herbert Walker Bush was President. If we are going to waste our time looking back on nominations past instead of looking ahead, let's not forget the 54 nominees the Democratic- controlled Senate left at the end of the 102nd. That is 13 more than the number of Clinton nominees left at the end of the 106th whom we hear so much about, and about 17 of them didn't have a chance anyway. The rest of them there were for reasons. Some of them, the blue slips weren't returned by Senators. You can't call them up. I don't really think to talk about past congressional action on nominations in any way furthers the work we have been doing as a committee. However, it is difficult to listen to only a select portion of what has occurred in the past without trying to set the record straight. Those Bush 1 nominees who were never confirmed are just as important as these Clinton nominees who have been complained about, and there were far more of them than there were Clinton nominees left over. It is just a matter of fact. Whoever is President, you have some nominees left over. But there were a lot more left over by Democrats than there were by Republicans. Let me name some of them: Jay C. Waldman of the Third Circuit, nominated for the Third Circuit; Franklin Van Antwerpen, Third Circuit; Lillian R. BeVier, Fourth Circuit; Terrence W. Boyle, Fourth Circuit, who has been sitting here for 14 months, nominated again 10 years later; Francis Keating II, current Governor of Oklahoma, the Tenth Circuit; Sidney A. Fitzwater, Fifth Circuit; John G. Roberts, again, nominated by the second Bush 10 years later, sat there all those months in the first Bush, and now he is sitting here for 14 months in this administration; John A. Smietanka, Sixth Circuit; Frederico Moreno, Eleventh Circuit; Justin P. Wilson, Sixth Circuit; James R. McGregor, Western District of Pennsylvania; Edmund Kavanagh, Northern District of New York; Thomas Sholtz, Southern District of Florida; Andrew O'Rourke, Southern District of New York. There are plenty of names and an awful lot more than were left at the end of the Clinton administration, and with very little justification. They have seldom mentioned that the all-time confirmation champion was Ronald Reagan with 382 judges. He had 6 years of a favorable party Senate. His own party controlled the Senate. He got 382 judges through. President Clinton, with the opposition party controlling the Senate, with me as chairman, as a member of the opposition party, got 377 judges through, virtually the same number as the all-time confirmation champion, Ronald Reagan. Continuing my list of judges: Tony Graham, Northern District of Oklahoma; Carlos Bea, Northern District of California; James Franklin Southern District of Georgia; David Trager, Eastern District of New York; Kenneth Carr, Western District of Texas; James Jackson, Northern District of Ohio; Terral Smith, Western District of Texas;, Paul Schechtman, Southern District of New York; Percy Anderson, Central District of California; recently confirmed; Lawrence Davis, Eastern District of Missouri; Andrew Hane, Southern District of Texas; recently confirmed; Russell Lloyd, Southern District of Texas; John Walter, Central District of California; recently confirmed; Gene Vougts, Western District of Missouri; Manuel Quintana, Southern District of New York; Charles Banks, Eastern District of Arkansas; Robert Hunter, Northern District of Alabama; Maureen Mahoney, Eastern District of Virginia; James Mitchell, District of Nebraska; Ronald Leighton, District of Oklahoma; William Quarles, District of Maryland; James McIntyre, Southern District of California; Leonard Davis, Eastern Northern District of Texas; recently confirmed; Douglas Drushal, Northern District of Ohio; Christopher Hagy, Northern District of Georgia; Lewis Leonatti, Eastern District of Missouri; Raymond Finch, Northern District of Vermont; James McMonagle, Northern District of Ohio; Katherine Armentrout, District of Maryland; Larry Hicks, District of Nevada; Richard Casey, Southern District of New York; Edgar Campbell, Middle District of Georgia; Joanna Seyvert, Eastern District of New York; Robert Kostelka, Western Northern District of Louisiana; Richard Dorr, Western District of Missouri; has had a hearing; James Payne, District of Oklahoma, confirmed this congress; Walter Prince, District of Massachusetts; George O'Toole, Jr., District of Massachusetts; William Dimetroulas, Southern District of Florida; Henry Saad, Eastern District of Michigan--not to mention Kenneth Ryskamp, who, like Charles Pickering, was voted down in committee and never received a full Senate vote. Let me also say I am going to get into this because I didn't think we would get down to the point where we started talking about a 115-member club that is a social club, not a business club, and virtually everybody knows it. To make that the big brouhaha that this is supposed to be is just almost beyond belief to me. I didn't want to have to talk about that, but I will be happy to. I rise today to express my strong support for Judge D. Brooks Smith whom the President nominated on September 10 of last year for the Third Circuit Court of Appeals to be confirmed today or tomorrow. It has been over 5 months since his committee hearing. It has been over 60 days since the Judiciary Committee reported Judge Smith's nomination favorably to the Senate. I am disappointed, however, with the treatment Judge Smith is getting from those whose well-funded business it is to oppose President Bush's nominees. I have warned before of the growing power of the extreme left of mainstream special interest groups upon the judicial confirmation process. Almost all of them are right here in this town. My colleagues know full well that when I was chairman of the Judiciary Committee, I did not welcome conservative groups telling the committee how to vote and what to do. I told them to get lost. I even directed my staff to refuse briefings from them and even meetings with them. But the evidence indicates a very different relationship now to liberal special interest groups that seem to call the shots. Newspapers from the Wall Street Journal to the Washington Post have commented on these liberal special interest groups and on their control of this process. But it is not a matter of opinion; here is the evidence. I would like to have printed in the Record evidence of this unfortunate relationship. First is a fundraising letter from People for the American Way taking credit for the rather shameless defeat of Judge Charles Pickering's nomination; second, a letter from a liberal Hispanic organization telling the committee not to bring up the nomination of Miguel Estrada until August to give them time to prepare a Pickering-like campaign against him. The President nominated Miguel Estrada over 1 full year ago. He would be the first Hispanic to sit on the Nation's second most influential court. But the Democratic leadership refuses to give him a hearing. Now I think we know why. Lastly, I want to have printed in the Record a press release from the National Organization For Women, issued just hours after the Judiciary Committee voted to report favorably the nomination of Judge Brooks Smith to the full Senate. It appears that NOW and other radical liberal groups have demanded that the Democrat leadership come to the floor and fight to defeat Judge Smith. I ask unanimous consent that the documents I have just referenced be printed in the Record.

Mr. HATCH. Referring in the most vitriolic terms to my friends, Senators Biden and Edwards, voting for Judge Smith in committee, NOW begins by saying: The field of credible Democrats running for President was significantly narrowed today. . . . This is simply because these Senators exercised their independent judgment and supported Judge Smith. Honoring the President's prerogative to nominate judges should hardly be a cause to attack my Democrat colleagues or take them out of a potential Presidential candidacy or race. Rather than speak further about Judge Smith's enemies, I would like to speak about his friends. I think an editorial in the liberal Pittsburgh Post-Gazette put Judge Smith's nomination best when they wrote: Outside Washington's world of partisan politics, Smith seems to have no enemies, only admirers. Those who have watched him work say an exemplary 14-year record in the Federal bench in Western Pennsylvania is being twisted by political opportunists. His popularity outside the capital extends even to members of the opposing political party, who describe him as fair, hard-working, and respectful to all. I hope I am not alone in this Senate in finding this home-town report much more reliable and convincing than the hit pieces circulated by the Washington left-wing special interest groups, or for that matter the New York Times, which I read faithfully everyday and respect in many ways--but not in this instance. But given the bipartisan support Judge Smith enjoys from the people who know him best, and his stellar record, I find it most difficult to accept that the opposition to him has centered on his belonging to an all-male, family oriented fishing club where his father first taught him to fly fish--the same rustic club that Jimmy and Roslyn Carter have visited to escape, relax, and fish. If this is the kind of thing that members of the body use as an excuse for thwarting the President's judicial nominations, then the American people will have a big laugh at our expense. And rightly so. In fact, there are hundreds of small, family-oriented fishing clubs like the one Judge Smith belonged to all across this country from Washington to North Carolina. I even pointed out the website called www.womensflyfishing.net, which lists the 60 or so women-only fishing clubs across the country. We are far from those days when prestigious downtown clubs kept women out of their facilities, and in any case that is not the nature of Judge Smith's family-oriented, fly-fishing club. The special interest groups out to get Judge Smith on this count are proving that when the only tool you have is a hammer, everything you see starts looking like a nail. In fact, there is a rich mosaic of single gender social clubs in this country that are entirely unobjectionable to any reasonable person. You should not be surprised to know, Mr. President, that this country is well-served by over 6,500 women's only clubs of every size. Are Judge Smith's opponents in this Senate really prepared to say that the members of the important Francesca Club in San Francisco or the powerful Raleigh Women's Club, or the Junior Leagues throughout the South and all over the country, or the Masons, or the Knights of Columbus cannot serve as judges? Perhaps the reason for this misguided line of attack on Judge Smith lies in the fact that, in his 1988 confirmation hearing before the Judiciary Committee, he stated that he believed the Judicial Code would require him to try to open the club to women, and to resign if he failed. But the fact is that he was wrong in that belief. The Judicial Code does not require resignation from clubs whose principal purpose is social, that do not function as public accommodations serving food to the public, or whose principal purpose is other than business. Mr. President, the building you saw has a living room, a kitchen, two bathrooms, and six bedrooms on the second floor. It is not a great big building, even though they blew up a picture to make it look like it was. Even if it was, it is used only for social purposes, and then by a membership of 115. By the way, that club does not have public accommodations. It does not serve food to the public. It does not do business with the public. No legalistic parsing of words can change this fact, even though any motivated lawyer can certainly confuse the issue, as we have seen in the Judiciary Committee. It is not surprising, of course, that the Judge Smith's detractors have chosen to disregard the clear constitutional standards articulated by the Supreme Court as well as the letter of the public accommodations law of Pennsylvania. After 1988, when the issue of single gender clubs was at its most heated peak, the Judicial Conference adopted standards pursuant to Supreme Court's decisions. It made clear that there was nothing--absolutely nothing--improper about a judge or nominee belonging to single-gender clubs, which exist in great numbers for both women and men in this country, so long as the association or club exhibits certain attributes of privacy first articulated by the Supreme Court in the 1984 case of Roberts v. Jaycees. Judge Smith was under no obligation to make efforts to open the club to women--as he promised this committee--or to resign from the club. But he did both, even though he had no obligation to do so. Opposing Judge Smith because he used to belong to a fisher-men's club is most absurd when contrasted with Judge Smith's record. Judge Smith, who currently serves as Chief Judge for the Western District of Pennsylvania, has earned a reputation for competence, fairness, and judicial temperament during 14 years as a Federal judge. I used to practice law in that district and tried cases in the Federal District Court of Western Pennsylvania. Judge Smith was appointed to that job at age 36--he was one of the youngest Federal judges in the country--and he came to it with experience as a state court judge, as a prosecutor, and as a private practitioner. His nomination is supported by lawyers, judges, and public figures from across the political spectrum. The Pittsburgh Post-Gazette, a respected newspaper with a liberal editorial viewpoint, has endorsed his nomination three times. The accounts of the people who know Brooks Smith best became real to me a few weeks ago when I listened to tremendously moving stories of women lawyers from Pennsylvania who recounted emotionally powerful events where Judge Smith bent over backwards to help them succeed as pregnant women and mothers in the practice of law. The truth is that Judge Smith is supported in the strongest possible terms by the women leaders and members of the Women's Bar Association of Western Pennsylvania, the Allegheny County Bar Association, and the Blair Bedford Domestic Abuse Advisory Board, to name a few. The Women's Bar Association gave Judge Smith their Susan B. Anthony Award ``because of his commitment to eradicating gender bias in the court system.'' That is a remarkable laud. The officers of the Women's Bar have also stated that they ``did not receive a single complaint concerning Judge Smith.'' To attempt now to taint Judge Smith as being insensitive to women's rights or interests is really beyond the pale of fairmindedness, if not decency. Judge Smith, who is currently the Chief Judge for the Western District of Pennsylvania, has earned a reputation for competence, fairness, and judicial temperament during his 13\1/2\ years as a Federal judge. He was appointed to that job at age 36--he was one of the youngest Federal judges in the country--and he came to it with experience as a State-court judge, as a prosecutor, and as a private practitioner. I briefly recount Judge Smith's record because it highlights the nature of the prejudice that occurs when a nominee or any person is judged on a single, private and lawful lifestyle choice. It seems to me that the root of all intolerance begins with just that act: to judge a person's entire worth based on a single characteristic, whether it be how a person exercises his or her freedom or religion or his of her freedom of association, which, like religion, has contributed so much to this Nation's unmatched vitality. I believe the Senate suffered a great shame when it ruined whole careers in the 1950s by asking a single infamous question intruding into the freedom of association. I was ashamed when the Judiciary Committee echoed this question last year by questioning nominees about the Federalist Society, as distinguished an association of lawyers as there could be. Now the special interest groups are asking the Senate to deny the President's nominee a confirmation on the basis of a fly fishing club. I fear the American people, are going to roll their eyes at the Senate with these type of accusations. But the truth of it is that if we disregard the right of lawful association, it will be no laughing matter. The Supreme Court first recognized the freedom of association in 1958 as an extension of first amendment free speech in NAACP v. Alabama, and most recently it reaffirmed the right in Boy Scouts of America v. Dale. It is a right, as Justice Thurmond Marshall wrote, ``which our system honors'' and that encourages ``all-white, all-black, all-brown, all- yellow clubs, as well as all-Catholic, all-Jewish as well as all- agnostic clubs to be established.'' And, it is a right that applies, Mr. President, as Justice Sandra Day O'Connor noted, to clubs whose purposes would be ``undermined if they were unable to confine their membership to those of the same sex, race, religion, or ethnic background.'' We should be glad that our personal politics are trumped by this American freedom because it has protected groups as diverse as the Communist Party and the Moose Lodge, and from the NAACP to the Boy Scouts of America. The freedom of association has protected the thousand points of light that have made this country's public life so vibrant. And it helps to distinguish us from those foreign places where people are shunned or even imprisoned for mere memberships in unpopular associations. While the constitutional right of association at first related to expressive association and protected unpopular groups, like the NAACP, in 1984, the Supreme Court articulated the right of intimate association concerning clubs such as Judge Smith's small fishing club. It did so while enforcing Minnesota's public accommodations law against a large single gender organization organized principally for business purposes. That is not the case here. The Court described the attributes of such intimate associations that the Constitution honors, including ``relative smallness.'' That is the case here. Judge Smith's former club has only 115 members. It has been around for a lot of years and has had both women and men enjoy the benefits. An intimate association, said Justice Brennan, writing for the Court, must be protected ``as a fundamental element of personal liberty,'' and ``must be secured against undue intrusion . . . because of the role of such relationships in safeguarding the individual freedom central to our constitutional scheme.'' As Justice Brennan explained, such small clubs transmit our culture and ``foster diversity.'' They foster pluralism. I for one stand by our freedom of association. As Justice Thurmond Marshall pointed out, it is a freedom that has helped make this country great, and a freedom we honor. I hope that all on this Committee do also, and that Judges, or people who might want to be Judges someday, are just as free as anyone else to exercise that right lawfully. Now, Senators who do not share my reverence for this First Amendment right will be interested to know that the State of Pennsylvania has a law against clubs that discriminate on the basis of gender. Pennsylvania has not sought to regulate the club Judge Smith resigned from--and for a good reason: that club does not violate the law against discrimination. In fact, Pennsylvania courts have found single-gender clubs to be permissible not on the basis of First Amendment rights, but as a privacy right, citing Griswold v. Connecticut. It would certainly be an entertaining footnote to Griswold jurisprudence if opponents of Judge Smith, who have seen fit to probe Judge Smith's views on Griswold, voted against him for exercising privacy rights emanating from that very case. The special interest groups that are working to discredit Judge Smith apparently think that President Bush's circuit court nominees deserve to have their records distorted and their reputations dragged through the mud. But I don't think that any judicial nominee deserves such treatment, and that was something I practiced as chairman for 6 of President Clinton's 8 years in office. I strongly agree with the Washington Post editorial of February 19, 2002, and nobody would suggest the Washington Post is a conservative newspaper, that ``opposing a nominee should not mean destroying him.'' The Post pointed out, ``The need on the part of liberal groups and Democratic senators to portray a nominee as a Neanderthal--all the while denying they are doing so--in order to justify voting him down is the latest example of the degradation of the confirmation process.'' I continue to hope that my colleagues will be sensitive to the dangers to the judiciary and to the reputation of this body that will certainly result from the repeated practice of degrading honorable and accomplished people who are will to put their talents to work in the public service. I urge my colleagues to examine Judge Smith on his record, and not on superficial and unsubstantiated allegations. When Judge Smith comes for a vote we will have the opportunity to show that the senate is focused on the merits of President Bush's nominees, and is not out to obstruct them in the name of sensibilities far from the mainstream of the American people. I hope we take it. I hope we vote favorably on a fine judge. My colleague has made a point in the past that somehow men's clubs are problematic and powerful and that women's clubs are somehow different and poorer. That is not a problem. I have a photo of an all- women's club. This is the Sulgrave Club of Washington. I, for one, believe they have a right to have an all-women's club. If my colleagues have trouble seeing the club, it is a mansion. It is not just a living room, kitchen, and six bedrooms upstairs. It is the building behind the Jaguar, the Lexis and, of course, the Mercedes. It is not itty-bitty by anybody's stretch of the imagination. And it is probably in a historical landmark situation. My colleague has also mentioned the ethicists who have written to condemn Judge Smith. Other ethicists have written to support Judge Smith. One of these Democrat ethicists, by the way, is the one standing on the car. If my colleagues cannot see it because it is a little dark, maybe the camera can come in a little closer. That is one of the ethicists they can get to write almost any opinion they want. This ethicist has argued in favor of introducing false testimony into a trial and argued perjured testimony to a jury. This is a photograph of another of the regulars who write to denounce President Bush's nominees. I might add, again, he is the one standing on top of the police car. We expect to have a lot of other letters from this particular ethicist. This is the type of stuff we are putting up with. I think it is time to stop it. I think it is legitimate for people to differ on a judge's qualification from time to time, but there is little or no reason to differ on this one. This is a good man. I hold a license in that area. I know the top lawyers in that area. I tried against a number of the top lawyers in that area. I have to say I do not know any of them who are not in favor of Judge Smith, and that ought to count more than some of these bits of calumny that have been thrown his way by some who do not like President Bush's nominees.

Mr. HATCH

Mr. HATCH. Mr. President, I listened to the impassioned speech of the Senator from Massachusetts. The fact is, there will not be any medical liability insurance companies. One major company has gone out of business because of what amounts to unreasonable litigation all over the country. It used to be that all you had to do was show that you met the standard of practice in the community and that was enough to alleviate doctors from medical liability. When the doctor of informed consent came into being, then every case from that point went to a jury. The reason is because they could make any claim they wanted, and ingenious lawyers can write the claims so they go to the jury. We have a crisis in this country. I estimated 15 years ago that at least $300 billion a year was being wasted in unnecessary defensive medicine. If anything, that number has gone up. Mr. President, 50.5 percent of family practitioners in Utah have given up obstetrical services or never practiced obstetrics. Of the remaining 49.5 percent still delivering babies, 32.7 percent plan to stop providing OB/GYN services within the next decade. Most plan to stop within the next 5 years. The people who are really going to be hurt will be the most vulnerable people in our society, the children. Frankly, we have to stop letting this medical liability situation go stock wild. It is way out of control. This is an amendment that does make intelligent approaches to trying to resolve the problems. This is an important issue about which I have spoken on previous occasions. I am pleased to see that on July 25, President Bush announced his desire to address the medical malpractice problem. We welcome his support in this effort. As many of you will recall, we debated, and passed, the exact provisions that are contained in the McConnell amendment during the Commonsense Product Liability and Legal Reform Act debate back in 1995. Unfortunately, the language was stripped from the bill in conference. I will say many of the same things now that I said back then, because, regrettably, they still apply and need to be said. I am sorely disappointed that in the ensuing seven years we have still not acted to address the fact that medical malpractice costs have spiraled out of control and are forcing many doctors and hospitals out of the profession. The situation has gotten worse, not better. We must act now if we are at all serious about fixing the crisis in healthcare delivery this has caused in many parts of this country. Make no mistake, we have a healthcare crisis in this country, one that is due in large part to litigation that is out of control. Many may not be aware of just how serious the ramifications of the crisis are. I will ask unanimous consent to have printed in the Record a July 18 Associated Press article, ``Soaring Malpractice Insurance Squeezes out Doctors, Clinics,'' which highlights these problems. The article points to the ``national problem that doctors say is obliging many of them to flee certain states or give up certain specialties--or the entire profession--because of skyrocketing insurance premiums linked to soaring jury awards.'' The article goes on to note that, as I am sure my colleagues from Nevada are acutely aware and Senators McConnell and Frist already mentioned--the University Medical Center trauma clinic in Las Vegas-- the only Level 1 trauma center in Nevada--closed down on July 3 of this year. The 58 doctors who were associated with the trauma center had insisted on much-needed relief from the soaring cost of medical malpractice insurance. Consequently, the day after the center closed, a victim of a serious traffic accident had to be transported to the next nearest emergency room which was an hour away. The trauma center was hurriedly reopened on July 13, but with only 10-15 doctors working on a temporary basis, with limited liability, while the Governor tries to enact legislation limiting awards in medical malpractice cases. We don't know if that trauma center will be forced to close again. Commenting on the trauma center's closure, its Director, Dr. John Fildes, stated that ``the standard of care in our community was set back 25 years.'' No one knows whether the life of that tragic accident victim in Las Vegas could have been saved had he been treated at the nearby hospital. Would any of us want that to happen to our loved ones--traveling an hour to receive emergency care? I certainly wouldn't, and the Senate should take the necessary steps to ensure that it does not happen to anyone else. The problem of providing necessary healthcare in the face of rising insurance costs and the threat of excessive litigation cuts across multiple specialties, not just emergency services. Ensuring the availability of adequate obstetric care continues to be a rising problem. According to the same article, one Arizona hospital, a clinic in Oregon, and two Pennsylvania hospitals recently have closed their obstetrics units. Several counties in upstate New York have no obstetricians covering night shifts. There is an increasing shortage in my home state of Utah as well. Studies by both the Utah Medical Association and the Utah Chapter of the American College of Obstetricians and Gynecologists underscore the problem in my state: 50.5 percent of Family Practitioners in Utah have already given up obstetrical services or never practiced obstetrics. Of the remaining 49.5 percent who still deliver babies, 32.7 percent say they plan to stop providing OB services within the next decade. Most plan to stop within the next five years. According to this Utah Medical Association study: Professional liability concerns [was] given as the chief contributing factor in the decision to discontinue obstetrical services. Such concerns include the cost of liability insurance premiums, the hassles and costs involved in defending against obstetrical lawsuits and a general fear of being sued in today's litigious environment. Mr. President, ensuring the availability of quality prenatal and delivery care for the most vulnerable members of our society is imperative for obvious reasons. The newly-released Department of Health and Human Services report ``Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Cost by Fixing our Medical Liability System'' released by HHS Secretary Tommy Thompson includes a detailed review of recent studies on the consequences of out-of-control medical liability crisis that is threatening healthcare in many parts of America. Even volunteer medical services are threatened. According to the report, ``[m]any doctors cannot volunteer their services for a patient who cannot pay, and the proportion of the physicians who provide charity care at all has declined, because doctors cannot afford the required liability coverage.'' It further details the rising costs of insurance premiums: Doctors alone had to pay over $6 billion in medical liability premiums last year, and premiums this year in many states have increased by more than 20 percent on average and more than 75 percent for specialties in some states. . .Excessive liability also adds $30 billion to $60 billion annually to Federal government payments for Medicare, Medicaid, the State Children's Health Insurance Program, Veterans' Administration health care, health care for Federal Employees, and other government programs. The HHS study further details how reasonable medical malpractice reforms in some states have been working to reduce healthcare costs and improve access and quality of care. I urge my colleagues to read this report. Our entire medical system--which everyone knows is heralded as the best in the world--is based on a total reliance on the abilities of the health care professionals who treat us, professionals who have sacrificed immeasurably to get the requisite training and credentialing. These are professionals who spend long and hard hours in school and at work to make our system the best in the world. Will there be mistakes? Of course there will be; we are only human. And while we must strive for perfection, that by definition cannot be. My heart goes out to each and every person who has suffered an adverse medical event, whether it was caused by the medical delivery system or not. I was a trial attorney before I came to Congress. I saw heart- wrenching cases in which mistakes were made. But I also saw heart- wrenching cases in which mistakes were not made and doctors were forced to expend valuable time and resources defending themselves against frivolous lawsuits. I have litigated these cases, both as an attorney for the plaintiff and as an attorney for the defendant. No one in this body knows better than I--perhaps with the exception of our colleague from Tennessee, Senator Frist--what the defects are in this system. Mr. President, I wish we could design a system which would protect each and everyone from harm, but that is not possible. Our job is to design the best system we can. But in a country as large and diverse as this one, problems are inevitable. The task before us is to make sure the system minimizes those problems. Thus the question before us is: how to design a system which protects both the patient and the provider? I do not believe that a protracted war between trial attorneys and health care professionals is the way to accomplish that goal. Why do we need to pass this amendment dealing with medical malpractice liability? Medical liability costs are out of control, as I have already stated. President Bush's Council of Economic Advisers published a paper in April estimating that the U.S. tort system, costing $180 billion, of which medical torts comprise a large part, is the most expensive in the world as a percentage of gross domestic product, equivalent to a three percent tax on wages. Professional liability rates are rising in response to our runaway tort system. And liability costs are having a direct impact on healthcare spending. It is often the case that doctors feel compelled to run diagnostic tests that are costly and unnecessary, in order to cover themselves--it is defensive medicine. It is wasteful, but unfortunately has become necessary. The only way to stop this is to get some reason into the system. Senator McConnell's amendment attempts to address many of the problems in this area by instilling a much needed measure of stability into our legal lottery that will benefit both patient and provider. How? This amendment would take the following, necessary, steps: To start, the amendment sets standards for punitive damages. In order for a claimant to receive such damages, he or she must prove by clear and convincing evidence that either: The defendant intended to injure the claimant for a reason unrelated to health care; The defendant understood the claimant was substantially certain to suffer unnecessary injury and yet still deliberately failed to avoid such injury; or The defendant acted with a conscious, flagrant disregard of a substantial and unjustifiable risk of unnecessary injury, which the defendant failed to avoid in a manner which constituted a gross deviation from the normal standard of conduct. Furthermore, punitive damages would be limited to two times the sum of compensatory damages, which includes both economic and non-economic damages. With our current system, defendants who are only one percent at fault could be held responsible for 100 percent of the award--which certainly does nothing to encourage doctors to continue to provide care. Under this amendment, there would be proportionate liability for non-economic and punitive damages, so that doctors are only liable for their actual share of damages if culpability is established. However, joint liability would remain for economic damages. In addition, courts would be allowed to require periodic payments for large awards rather than lump sums, which makes it easier for insurers to judge their appropriate reserves. I would note that under Utah law, periodic payments for awards of over $100,000 are mandatory. This does not reduce the claimant's award. Past and current expenses will continue to be paid at the time of judgment, while future damages can be funded over time with less risk of bankrupting the defendant. Awards in malpractice cases also would be reduced by the amount of compensation received from collateral sources, in order to prevent the practice of ``double dipping.'' This amendment also limits attorneys' fees, but I think, in a reasonable manner. Attorneys' fees that could be paid out of an award would be limited to 33 percent of the first $150,000 and 25 percent of any amount awarded above that. I have to say, I am concerned about any limitation on attorneys' fees, but there have been some colossal rip- offs in this area and this appears to be a reasonable approach in the McConnell amendment. Lawyers should be compensated, and they should be fairly and reasonably compensated. But studies have shown that a surprisingly low proportion of every dollar spent on liability litigation ever reaches patients. That is a strong indication that our liability system has been turned squarely on its head. Despite all the tremendous litigation costs, the beneficiaries seem to be lawyers, not patients. This important provision ensures that the injured party will receive more of the award, and the attorney less. The amendment would further require that a medical malpractice complaint must be filed within two years after the claimant discovered, or in the exercise of reasonable care should have discovered the injury and its cause. This is similar to the law in Utah, which provides for a 2-year statute of limitations, with a 4-year maximum. And with regard to obstetric care, to address the rising number of lawsuits filed against emergency room doctors who deliver babies of women they have not previously treated, this amendment incorporates an amendment offered by Senator Thompson back in 1995 which passed overwhelmingly. Under this provision, for obstetric services, if a health care provider had not previously treated the pregnancy, the provider shall not be found to have committed malpractice unless proof of the malpractice meets the standard of clear and convincing evidence. This amendment also encourages states to develop a state-based alternative dispute resolution mechanism to avoid the necessity of going to court. I have long felt that our fault-based liability system may not be the most equitable or the most efficient. it is expensive, time consuming, and unpredictable. The McConnell amendment also requires that a portion of all punitive damage awards be set aside to: No. 1, improve state licensing, investigating, and disciplining of medical professionals; and, No. 2, reduce medical malpractice expenses for physicians who volunteer to provide care in medically under served areas. Finally, the scope of this amendment applies to all federal and state medical malpractice cases, except in those states that already have stronger medical malpractice reforms. Mr. President, it is clear that we need to do something to deal with this crisis, and I believe the McConnell amendment is a step in the right direction. What is important is that we take steps to benefit both the patient and the health care provider, not the trial lawyers-- otherwise we are in danger of losing access to necessary healthcare. I urge my colleagues to support this amendment.

Mr. HATCH

Mr. HATCH. Mr. President, I do have to make a few remarks since my colleague from New York made some very cogent, very important remarks this evening. I happen to have a lot of respect for my colleague from New York, and he has the guts to really stand up and say that one of the reasons he is voting against some of these judges is the question of ideology. I think he is dead wrong on that, but the fact is, I respect him for at least being upfront and stating what he believes. He has also said we need to have balance on the courts. I am not so sure that is a bad concept, but I believe whoever is President, we have to have that President's choice of judges. That is one thing we do when we elect a President. Unless you can find some really valid reason for voting against these judges, that I think has to be more than ideology--at least that is my view--then you should vote for those judges, which is a practice I have followed throughout the Clinton administration and throughout the Carter administration, as a matter of fact. I think it is the correct practice. I still respect my colleague for his beliefs, for his forthright statements. I want to correct the record on a few things. No. 1, with regard to balance, there is a lack of balance in many circuit courts of appeals today one way or the other. In the Ninth Circuit Court of Appeals, 17 of the 23 judges are Democrats; 14 were appointed by none other than President William Jefferson Clinton. In the Second Circuit Court of Appeals, the majority of them are Democrats. These are two very important circuit courts. In the Circuit Court of Appeals for the District of Columbia, it could very easily have been that way. It comes down to whoever is President. That is one of the things we do when we choose a President: We choose the person who is going to pick the judges for the next 4 years. And I believe, unless you have a legitimate reason--and it has to be a very legitimate reason for opposing those judges--you need to vote for them. I heard the distinguished Senator from Vermont tonight say Judge Smith rules too much for corporations. Give me a break. He has been on the bench 14 years. He has ruled for everybody during those 14 years. And, by the way, occasionally corporations are right. And if they are right, as judges in this country they ought to rule in their favor if it is a nonjury trial. They ought to be fair in their instructions if it is a jury trial and in the conduct of the trial if it is a jury trial. Brooks Smith has had that type of reputation. With regard to another comment of my friend from New York, he continues to repeat a myth that arose out of the Clarence Thomas proceedings. I happened to be there during those Clarence Thomas proceedings, and that myth is that he said he never discussed Roe v. Wade. That is not what he said. He was asked directly, and he said: I never debated it with my philosophy classmates. That is a considerably different answer. And from that, they extrapolated he never discussed it, and he wasn't asked any further questions about it by the same person who asked that question. The fact of the matter is, some ideologically disagree with Justice Thomas. Many on our side disagree with Justice Thurgood Marshall. I happened to have respected him greatly. I didn't agree with a lot of the things he wrote, but I also respected him. Clarence Thomas is writing some of the most literate, intelligent decisions on the Supreme Court right now. Let me say the danger of the position of my friend from New York, in saying ideology counts, is: Whose ideology? Because I have seen some very conservative judges get on the bench and become very liberal judges almost overnight. I have seen some very liberal judges get on the bench and become very conservative judges--maybe not overnight but certainly in time. I have to ask you, if you start talking ideology, whose ideology? There are differences on the Democratic side on ideology. There are differences on the Republican side on ideology. Are we going to have a single litmus test to bar somebody from serving just because they may be against Roe v. Wade or may be pro-life? Are we going to have a litmus test against somebody serving because they once participated as a corporate lawyer? A terrible thing to do, I guess. No, we should not do that. If we took that attitude, that Roe v. Wade is paramount and preeminent in all judicial considerations, there would have been very few Clinton judges. As I say, he came very close, virtually was the same as the all-time confirmation champion, Ronald Reagan. So that is the danger, in my belief and in my philosophy, of the position of the distinguished Senator from New York. I respect the position. I respect his openness. I respect his forthrightness. I respect him personally. He is very intelligent, a good lawyer--some would say a great lawyer. I would say that. I enjoy being with him on the Judiciary Committee. But his doctrine is a dangerous doctrine because--whose ideology? People have tried to stereotype me the whole time I have been in the Senate. I just got finished writing a book that will be published this fall. It is going to be called ``The Square Peg.'' Guess who the square peg is. The fact is, that book is going to show I don't particularly fit in any category. Neither does the Senator from New York. In some respects, he is a very conservative Senator. In other respects, he is very liberal. I have had the same thing said about me. Does that mean neither of us could serve on any court because we might be conservative on some issues, we might be liberal on other issues, that offend some in this body? No, it should not mean that. Look, if a person is out of the mainstream, that is another matter. But I have seen the argument come up time after time the judges are outside of the judicial mainstream. That is pure bunk, to be honest with you. They do not get through this process where they are nominated by any President of the United States by being outside of the mainstream. They just do not. Some are conservative and some are liberal. This President has nominated some very liberal judges. He has nominated some very good conservative judges. He has nominated people in between. He has nominated Democrats. He has nominated Republicans. But it is dangerous to say that anybody's personal ideology ought to determine whether a person serves on the bench if that person is otherwise qualified. I hope my colleague who is forced to sit there and listen to me at this time as the Presiding Officer will reconsider at least some aspects of his position because he may be chairman of the Judiciary Committee someday. When he is, he is going to find that in the interest of fairness, you have to presume and give the benefit of the doubt to the President's nominee, especially unless you can show that they are outside of the mainstream of American jurisprudence. I have to tell you that I haven't seen many--in my whole time in 26 years in the Senate and confirming almost every judge that currently sits on the Federal bench--that I would consider coming close to being outside of the mainstream of American jurisprudence. By the time they get through the vetting process at the White House, the vetting process of the FBI, the vetting process of the American Bar Association, and when they wind up with a well-qualified rating from the American Bar Association, you can't say they are outside of the mainstream of American jurisprudence, nor can you say that because they differ with you ideologically you have to vote against them. I happen to love my colleague. I just hope he will reconsider because I don't want him leading those who are less mentally equipped down the primrose path of partisan politics. I yield the floor to my dear colleague and friend from Florida, who has really fought that good battle on S. 812, which is something I very much respect.

Mr. HATCH

Mr. HATCH. Madam President, I ask unanimous consent that my aides, Christopher Rogers and Matt Hargraves, be granted the privilege of the floor for the duration of the debate on Judge D. Brooks Smith.

Mr. HATCH

Mr. HATCH. Mr. President, I rise in support of the nominations of three excellent Federal court judges, Judge Julia Smith Gibbons, Joy Flowers Conti, and John E. Jones. Judge Gibbons, nominated to the Sixth Circuit Court of Appeals last fall, is a jurist with a find legal mind, a strong work ethic, and a widely admired judicial temperament. I have reviewed few records of public service and personal accomplishment more outstanding than hers. It seems to me that it was for good reason that in 2000 she received a recognition called Heroine for Women in the Law Award. But that is just one of her accomplishments. Judge Gibbons graduated magna cum laude and Phi Beta Kappa from Vanderbilt University and then with honors from the University of Virginia School of Law, where she was an editor for the Law Review. She went on to clerk for the late Honorable William E. Miller on the Sixth Circuit Court of Appeals, where we now hope she will soon return after a distinguished career which has included service as deputy counsel for Governor Lamar Alexander and Tennessee State court judge. Since 1983 she has served as U.S. District Court Judge for the Western District of Tennessee, sitting with the Sixth Circuit Court of Appeals several times. Notably she was the first female Federal judge in Tennessee and one of the youngest Federal judges in history. Judge Gibbons exemplifies the qualities of the nominees the President has sent us--superbly accomplished, fully devoted to public service, and well prepared for the Federal bench. Judge Gibbons enjoys the support of Democrats and Republicans and everyone who knows her work. She is backed by her home State legislators. Senator Thompson says she is ``an outstanding person and jurist . . . [who will] serve the court with dignity and distinction.'' Senator Frist has described her a ``trailblazer for women in the legal profession [who] exemplifies in both her professional and personal life the character that makes us a great Nation.'' Democratic Congressman Harold Ford, Jr., has noted that Judge Gibbons has ``earned a solid reputation of applying the law in a manner consistent with our nation's commitment to equal protection under the law.'' Judge Gilbert S. Merritt, whose seat on the Sixth Circuit Judge Gibbons will occupy, calls her a ``very able and distinguished Federal judge'' and adds that he would be ``very happy to be replaced by her on our court.'' Members of the Memphis, TN, legal community have added their own high praise. For example, Pat Arnoult, president of the Memphis Bar Association, cites her ``keen mind'' and ``good work ethic.'' Charles Burson, former chief of staff and legal counsel to former Vice President Gore and Tennessee attorney general, cites with first hand experience her intellect, knowledge, evenhandedness, and exceptional judicial temperament. Judge Gibbons has won the respect and bipartisan support of legislators, attorneys, Federal judges, and Tennessee citizens. Judiciary Committee unanimously approved Judge Gibbon's nomination on May 2 after a hearing that raised no issues of concern. We have waited too long to act on her nomination on the Senate floor. With a 50 percent vacancy rate in the Sixth Circuit, we cannot afford to delay any longer. The two Pennsylvania district court nominees currently on the floor also deserve our full support. Joy Flowers Conti, nominated to the Western District of Pennsylvania, possesses years of civil litigation experience and years of meaningful service and leadership in her community. After graduation from Duquesne University School of Law, where she graduated summa cum laude and finished first in her class, Ms. Conti clerked for Justice Louis Manderino of the Supreme Court of Pennsylvania. For the following two years, Ms. Conti worked with the Pittsburgh firm of Kirkpatrick & Lockhart, where she focused on business bankruptcy, commercial finance, and other corporate law matters. She then joined the faculty of Duquesne School of Law as a professor, teaching classes on civil procedure, corporate finance, corporate readjustments and reorganizations, corporations and creditors' and debtors' rights. In 1982, Ms. Conti returned to her former firm, Kirkpatrick & Lockhart, and was named a partner in 1983. She again concentrated her practice in business bankruptcy. She remained with the firm until 1996, when she joined her current firm, Buchanan Ingersoll, to handle business bankruptcy cases, health care matters, and nonprofit corporation issues. While serving as cochair of the Pennsylvania Bar Association's Task Force for the Poor, she has helped with efforts to improve access to legal services for indigent residents. She also initiated a program proving employment for disadvantaged high school students in local legal offices, donating approximately 200 ours to the cause. John E. Jones, our nominee to the U.S. District Court for the Eastern District of Pennsylvania, is similarly distinguished jurist. Mr. Jones earned his undergraduate and law degrees from Dickinson College. After graduation, he joined the Pottsville law firm of Dolbin & Cori as an associated and worked part time as a clerk for Judge Guy A. Bowe of the Schuylkill County Court of Common Pleas. After 2 years, Mr. Jones became a partner at Dolbin & Cori. In 1984, Mr. Jones began an 11-year association as a part-time assistant public defender with the Schuylkill County Public Defender's Office. His caseload included defending capital murder and criminal homicide cases. Mr. Jones now works for his own firm, concentrating on bankruptcy, personal injury, family, real estate, and corporate law. In 1995, Mr. Jones was appointed and confirmed to the office of chairman of the Pennsylvania Liquor Control Board. The Control Board is responsible for the sale and regulation of all alcohol products in Pennsylvania. The Control Board also runs the State's Alcohol Education Program. As chairman, Mr. Jones has utilized his skills and experience as a practicing attorney to change the State's liquor licensing procedures. As head of the State's Alcohol Education Program, he has been a tireless advocate against drunk driving and underage drinking. In November 2000, Mr. Jones received the Government Leadership Award from the National commission Against Drunk Driving in Washington, DC. In May 1999, he was renominated and confirmed for a second 4-year term as Control Board's Chairman. I am confident that these three Federal court nominees-Julia Smith Gibbons, Joy F. Conti, and John E. Jones--will each make fine additions to the Federal judiciary. They deserve our swift confirmation

Mr. HATCH

Mr. HATCH. Mr. President, our health care system has increased the lifespan and quality of life of our citizens. Our population is aging; people with chronic conditions are living longer. The number of Medicare beneficiaries is increasing and will continue to increase as baby boomers retire. As I have listened to the debate over the last two weeks, I think we can all agree on one thing, the seniors in this Nation deserve the best possible health care, of which prescription drug coverage is a vital component. All of us want to provide Medicare beneficiaries with prescription drug coverage this year. Unfortunately we do not agree on how this coverage should be provided. I support the Tripartisan bill for several simple reasons. The Tripartisan bill operates on the fundamental principles of efficiency, quality, and choice. It balances all of the issues and provides a permanent solution--all of which result in cost savings and affordability. Balance is a key point here. We do not offer a plan that cannot be sustained, resulting in bigger problems down the road. We do not offer a plan that ends abruptly. We do not offer a plan offering everything to everyone, knowing full well that it cannot work, as the Graham-Kennedy bill does. We provide Medicare beneficiaries with four key elements: First; Choice. Giving seniors the right to choose a plan and the right to choose a particular medication is the greatest benefit we can offer Medicare beneficiaries. Under the Graham-Miller-Kennedy bill, seniors can only get a government run prescription drug plan. The Graham-Miller-Kennedy bill forces seniors and their physicians into government run formularies. This is not what we want for our seniors and their doctors; Second; Quality. I do not believe that the Graham-Miller-Kennedy bill has any incentive to improve quality--over and over, we have seen how government run programs have failed our health care system. Our Tripartisan bill makes a concerted effort to improve and modernize Medicare, by offering seniors choice not only in prescription drug coverage but for overall medical coverage as well; Third; Efficiency and Cost containment. The Tripartisan bill fosters competition, based on quality and cost. The Graham-Miller-Kennedy bill does not. The Graham-Miller-Kennedy bill cannot deliver drugs efficiently by making the government the sole regulator of Medicare drug coverage. The Tripartisan bill guarantees that at least two plans will compete in each region, giving seniors the right and choice to pick the plans that best suit their needs; and Fourth; Balance. The Tripartisan bill balances the needs of seniors with benefits. We improve coverage for the sickest, poorest seniors by helping needy seniors meet their health care costs through generous subsidies. We use an assets test to determine who needs assistance. What is so wrong with this? All we are doing is applying asset testing criteria for prescription drug coverage. I do want to make a correction to my statement from 7/22/02, The Family Opportunity Act does not have an assets test as I indicated. Rather it has an income and disability test. In conclusion, I believe the model of the Tripartisan bill is the only workable, long lasting, and fair plan for our seniors and taxpayers. The Tripartisan bill model is the only way to achieve a long-term solution to provide prescription drug coverage to Medicare beneficiaries and, at the same time, give seniors, their families, and doctors choice. It is not a quick fix to get immediate support for something that is not going to last, like the Graham-Miller-Kennedy bill. I am hopeful that more of my colleagues will recognize this, and help us reach an acceptable agreement.

Mr. HATCH

Mr. HATCH. Mr. President, my staff just attended a non-embargoed briefing conducted by the Federal Trade Commission. It is our understanding that tomorrow the FTC will transmit to the Congress and the American people a copy of its comprehensive study of the pharmaceutical industry with respect to litigation involving the two major components of the pending legislation: first, the report examined the use and abuses of the statutory 30-month stay. Second, the report examines how the 180-day marketing exclusivity rule has been the source of collusive arrangements between pioneer and generic firms. I will be very interested to study the full report when it released tomorrow morning. Let me say this tonight. First, I want to commend Chairman Muris and the other FTC Commissioners for undertaking this important study. I would also like to acknowledge the efforts of the FTC staff including, Maryann Kane, Mike Wroblenski and Sarah Browers for their work on this report. It is my understanding that the key recommendations contained in the report are somewhat at odds with the legislation on the floor. It is my understanding the first FTC recommendation, consistent with the position that I took at the Health Committee hearing May 8 and my floor statements the past two weeks, will basically say that there should only be one automatic 30-month stay per drug product per ANDA to resolve challenges to patents listed in the FDA Orange Book prior to the filing date of the generic drug application. Senator Gregg took this position in the HELP Committee and I commend him for his work to strengthen the bill. Clearly, as I have laid out in some detail in earlier speeches, the Edwards-Collins substitute delves into areas way beyond this recommendation. I also understand the second FTC recommendation, which touches upon the so-called reverse payment agreements whereby generic firms are paid not to market generic drugs, will suggest that the Congress pass legislation to require brand-name companies and first generic applicants to provide copies of certain agreements to the FTC. This is exactly what Senator Leahy's bill, S. 754, the Drug Competition Act, requires. As I discussed in my previous statements, I voted for Senator Leahy's bill in the Judiciary Committee and worked with him to refine the final language. In my view, S. 754 contains a much more measured--and certainly more comprehensible--approach than does the Edwards-Collins substitute. Because the staff briefing just occurred and the full report will be issued tomorrow, I am not prepared tonight to give you my full evaluation of the FTC report. But I can say that the major recommendations of the FTC appear to be somewhat at odds with key provisions of the legislation that is pending on the floor, the Edwards-Collins substitute to S. 812. I look forward to examining the data collected by the FTC and analyzing the report's two major recommendations and its several subsidiary recommendations. Frankly, I think that it would be appropriate for the relevant committees, the Judiciary Committee, the Commerce Committee, and HELP Committee, to have the opportunity to examine this comprehensive study before we adopt legislation in this area. I will be interested to learn if the sponsors of the bill on the floor would be open to a process that will allow a careful evaluation of what the FTC study reveals and will not just act to ram this legislation through in the last week before August recess. I have lodged my concerns about the way this bill so hastily was adopted by the committee and appeared on the floor, and urged that we take the time necessary to get this legislation right. The Hatch-Waxman Act is an important consumer bill that has helped save about $8 billion to $10 billion each year since 1984. So we should not be playing around with this bill, especially without the benefit of carefully studying this this soon-to-be-released FTC report. Once again, I urge my colleagues to do the right thing and give us an adequate opportunity to factor in this FTC study. It would be advisable to spend the time before the recess to adopt trade promotion authority rather than to continue to struggle with the hastily crafted and not fully vetted Edward-Collins substitute. In that regard, I pay specific tribute to our colleague, Senator Baucus, who represented the Senate so well in the trade conference that occurred Thursday evening and early Friday morning. I was a member of the conference committee. Senator Baucus did himself proud, did our body proud, did a very good job, as did Chairman Thomas. Those two worked very well together to come up with what is landmark legislation to help our economy move forward. It is one of the reasons I think the stock market turned around today. It is not the only reason. I think we would have another reason if we would treat the Hatch-Waxman language with the care and treatment it deserves before we go off half cocked to enact a bill before we examine the FTC study and its recommendations. I am grateful I serve on the Finance Committee with Senator Baucus and Senator Grassley, both of whom did a good job in this last conference on trade promotion authority. I also am very pleased one of my long-term friends in the Congress has been Chairman Bill Thomas in the House. It is a tough job being chairman of the Ways and Means Committee. It is a very divided committee in many respects; yet it works very well. There is no one in this Congress who does a better job on health care issues than Chairman Thomas. All of them deserve credit, as do the ranking members, Charlie Rangel, without whom this agreement probably could not have come to pass, a man for whom I have tremendous respect; and, of course, Senator Grassley in our body who has worked so well with Senator Baucus on so many pieces of legislation that mean so much to our economy and our country. These are important issues. I have given some rather lengthy speeches on the Hatch-Waxman issue and even some lengthy speeches on the trade promotion authority. I was one of those in the Finance Committee who pushed very hard to get the trade promotion bill on the floor and get us to conference. I express my regard for all concerned. I hope we can resolve this matter on the floor this week, but I believe trade promotion authority deserves even greater precedence than what we are trying to do in the underlying bill S. 812. If we act on the underlying bill, it ought to be done in a thoughtful fashion. It should not be done just politically. We ought to pay attention to the experts at FTC and elsewhere who have spent so much time on the issue. I yield the floor.

Mr. HATCH

Mr. HATCH. Mr. President, I had no intention of bringing up the topic of judicial nominations today, but I feel I must respond to the comments made just now. Curently there are 92 empty seats in the Federal judiciary, a 10.7 percent vacancy rate--one of the highest in modern times. This means that 10.7 percent of all Federal courtrooms are presided over by an empty chair. There are currently 22 nominees pending who are slated to fill positions which have been declared judicial emergencies by the Administrative Office of the Courts. Of those, 13 are courts of appeals nominees. During President Clinton's second year in office, the Senate confirmed 100 of his judicial nominees. I would expect the Senate Democrats to do the same for President Bush. But they are not doing so. Only 4 of President Bush's first 11 nominees--nominated on May 9, 2001--have had hearings. In other words, the Judiciary Committee has taken no action whatsoever on nearly two-thirds of the circuit court nominations that have been pending for over 14 months. There is no reason for this other than stall tactics. All of these nominees received qualified or well-qualified ratings from the American Bar Association. There were 31 vacancies in the Federal courts of appeals on May 9, 2001, and there are 30 today. The Senate Democrats are trying to create an illusion of movement by creating great media attention and controversy concerning a small handful of nominees in order to make it look like progress. But we are hardly making any progress in filling circuit vacancies. President Bush has responded to the vacancy crisis in the appellate courts by nominating a total of 31 top-notch men and women to these posts--but the Senate is simply stalling them. Over the past year, the Senate has confirmed only nine. There are still 22 circuit court nominees pending in committee. By comparison, at the end of President Clinton's second year in office, we had confirmed 19 circuit judges and had 15 circuit court vacancies. Mr. President, the comparison does not end there. There were only two Circuit Court nominees left pending in Committee at the end of President Clinton's first year in office. In contrast, there were 23 of President Bush's circuit court nominees pending in committee at the end of last year. Mr. President, some try to blame the Republicans for the vacancy crisis, but that is bunk. At the end of the 106th Congress when I was chairman, we had 67 vacancies in the Federal judiciary. During the past 9 months, the vacancy rate has been hovering right around 100. Today it is at 92. The real story here, Mr. President, is that the Senate's Democratic leadership is treating President Bush unfairly when it comes to judicial nominees. Some would justify this unfair treatment of President Bush as tit for tat, or business as usual, but the American people should not accept such a smokescreen. What the Senate leadership is doing is unprecedented. Historically, a President can count on seeing all of his first 11 circuit court nominees confirmed. Presidents Reagan, Bush and Clinton all enjoyed a 100 percent confirmation rate on their first 11 circuit court nominees. In stark contrast, 8 of President Bush's first 11 nominations are still pending now for over 1 whole year. History also shows that Presidents can expect almost all of their first 100 nominees to be confirmed swiftly. Presidents Reagan, Bush, and Clinton got 97, 95 and 97, respectively, of their first 100 judicial nominations confirmed. But the Senate has confirmed only 57 of President Bush's first 100 nominees. In sum, Mr. President, I think that the American people deserve better, President Bush deserves better, and the Judicial Branch of our Government deserves better. I yield the floor.

Mr. HATCH

Mr. HATCH. Mr. President, this morning we moved closer to the confirmation of Judge Julia Smith Gibbons of Tennessee to the 6th Circuit Court of Appeals. In so doing, we will bring relief to a Circuit with a 50 percent vacancy rate, with 9 empty seats out of 18, despite the fact that the President nominated 6 fine public servants to fill those seats on May 9, 2001, well over 400 days ago. I look forward to confirming her finally. I rise this morning to express my most profound concern for the course of judicial confirmations in general and my support for the confirmation of Justice Priscilla Owen of Texas. The Judiciary Committee gave Justice Owen a 5-hour hearing earlier this week, which I am afraid did not do credit to the Committee. I will comment on Justice Owens' qualifications, and to address some of the deceptions, distortions and demagoguery orchestrated against her nomination, that we have all read in the national and local papers. I would like first to comment on the two jingos that are being used about her record as if they had substance: namely, that Justice Owen is ``conservative'' and that she is ``out of the mainstream.'' Of course, this comes from the Washington interest groups, in many cases, who think that mainstream thought is more likely found in Paris, France, than Paris, Texas. I must admit that it's curious to hear it argued that a nominee twice elected by the people of the most populous State in the Circuit for which she is now nominated is ``out of the mainstream.'' Texans are no doubt entertained to hear that. Listening to some of my colleagues' commentary on judges, I sometimes think that main-stream for them is a northeastern river of thought that travels through New Hampshire early and often, widens in Massachusetts, swells in Vermont, and deposits at New York City. Well, the mainstream that I know, and that most Americans can relate to, runs much broader and further than that. The other mantra repeated by Justice Owen's detractors is that she is ``conservative.'' I believe that the use of political or ideological labels to distinguish judicial philosophies has become highly misleading and does a disservice to the public's confidence in the independent judiciary, of which the Senate is the steward. I endorse the words of my friend, and former Chairman of the Judiciary Committee, Senator Biden, when he said some years ago that: ``[Judicial confirmation] is not about pro-life or pro-choice, conservative or liberal, it is not about Democrat or Republican. It is about intellectual and professional competence to serve as a member of the third co-equal branch of the Government.'' I believe it is our duty to confirm judges who stand by the Constitution and the law as written, not as they would want to rewrite them. That was George Washington's first criterion for the Federal bench, and it is mine. I also want common sense judges who respect American culture. I believe that is what the American people want. I believe we do a disservice to the independence of the Federal judiciary by using partisan or ideological terms in referring to judges. My reason was well stated by Senator Biden when he said that: ``it is imperative [not to] compromise the public perception that judges and courts are a forum for the fair, unbiased, and impartial adjudication of disputes.'' We compromise that perception, I believe, when we play partisan or ideological tricks with the judiciary. Surely, we can find other ways to raise money for campaigns and otherwise play at politics, without dragging this nation's trust in the judiciary through the mud, as some of the outside groups continue to do. All you have to do to see my point is read two or three of the fund- raising letters that have become public over the past couple of weeks that spread mistruths and drag the judiciary branch into the mud, as many recent political campaigns increasingly find themselves. On a lighter note, while on ideology, let me pause to point out that one of the groups deployed against Justice Owen is the Communist Party of America, but then I don't know that they have come out in favor of any of President Bush's nominees. I suspect after the fall of the Berlin Wall, they must have a lot of time on their hands. Today I wish to address just why a nominee with such a stellar record, a respected judicial temperament, and as fine an intellect as Justice Owen has, who graduated third in her class from Baylor's law school, a great Baptist institution, when few women attended law school, let alone in the South, who obtained the highest score in the Texas Bar examination, and who has twice been elected by the people of Texas to serve on their Supreme Court, the last time with 83 percent of the votes and the support of every major newspaper of every political stripe, I would like to address just why such a nominee could get as much organized and untruthful opposition from the usual leftist, Washington special interest groups that we see. I will peel through what is at play for those groups. We need to expose and repel what is at play for the benefit and independence of this Senate. And I would like to address also the reasons why I am confident that she will be confirmed notwithstanding. Not least of which is that, far from being the ``judicial activist'' some would have us believe her to be, she garnered the American Bar Association's unanimous rating of ``well qualified.'' The Judiciary Committee has never voted against a nominee with this highest of ratings. The first reason for the organized opposition, of course, is plain. Justice Owen is from Texas, and Washington's well paid reputation destroyers could not help but attempt to attack the widely popular President of the United States, at this particular time in an election year, by attacking the judicial nominee most familiar to him. Justice Owen, welcome to Washington. But as I prepared more deeply for the Hearing earlier this week, the second reason became apparent to me. In my 26 years on the Judiciary Committee I have seen no group of judicial nominees as superb as those that President Bush has sent to us, and he has sent both Democrats and Republicans. In reading Justice Owen's decisions, one sees a judge working hard to get it right, to get at the legislature's intent and to apply binding authority and rules of judicial construction. It is apparent to me that of all the sitting judges the President has nominated, Justice Owen is the most outstanding nominee. She is, in my estimation, the best, and despite what her detractors say, she is the best judge that any American, any consumer and any parent could hope for. Her opinions, whether majority, concurrences or dissents, could be used as a law school text book that illustrates exactly how, and not what, an appellate judge should think, how she should write, and just how she should do the people justice by effecting their will through the laws adopted by their elected legislatures. Justice Owen clearly approaches these tasks with both scholarship and mainstream American common sense. She does not substitute her views for the legislature's, which is precisely the type of judge that the Washington groups who oppose her do not want. She is precisely the kind of judge that our first two Presidents, George Washington and John Adams, had in mind when they agreed that the justices of the State supreme courts would provide the most learned candidates for the Federal bench. So in studying her record, the second reason for the militant and deceptive opposition to Justice Owen became quite plain to me. In this world turned upside down, simply put, she is that good. Another reason for the opposition against Justice Owen is the most demagogic, the issue of campaign contributions and campaign finance reform. Some of her critics are even eager to tie her to the current trouble with Enron. Well, she clearly has nothing to do with that. Neither Enron nor any other corporation has donated to her campaigns, in fact, they are forbidden by Texas law to make campaign contributions in judicial elections. It was embarrassing to me, as it would be to any American who watched the hearing earlier this week, to see Justice Owen defeat these demagogic allegations, but being a Texas woman, she did so with style, elegance, and grace--and without embarrassing her questioners. Not that there was even a need for more questions. The Enron and campaign contributions questions were amply clarified in a letter to Chairman Leahy and the Committee dated April 5 by Alberto Gonzales. I will ask unanimous consent, to place this and other related letters into the Record. And I would place into the Record a retraction from The New York Times saying that they got their facts wrong on this Enron story. Such retractions don't come often, not as often as the invention of facts by the smear groups. And despite the retraction, CNN was repeating the same wrong facts just this week! Notably, at the hearing Justice Owen received no questions from my Democrat colleagues on her views on election reform and judicial reform, of which she is a leading advocate in Texas. She is also a leader in Gender Bias Reform in the courts and a reformer on divorce and child support proceedings. But my colleagues seemed to take little interest in this, nor in her acclaimed advocacy to improve legal services and funding for the poor. All of these are aspects of her record her detractors would have us ignore, I certainly did not read these positive attributes in those fancy documents, or should I say booklets, released prior to the hearing by the Washington radical special interests lobby. I will also ask unanimous consent, to place into the Record letters from leaders of the Legal Society and 14 past presidents of the Texas Bar Association, many of whom are leading Texas Democrats. The fourth reason for the opposition to Justice Owen is the most disturbing to me. For some months now, a few of my Democrat colleagues have strained to point out when they believe they are voting for judicial nominees that they believe to be pro-life. I have disputed this when they have said it because the record contains no such information of personal views from the judges we have reported favorably out of the Judiciary Committee. Each time they assert it, my staff has scoured the transcripts of hearings and turned up nothing. What does turn up is that each time my colleagues have asserted this, they have done so only for nominees who are men. I am afraid that the main reason Justice Owen is being opposed, is not that personal views, namely on the issue of abortion, are being falsely ascribed to her, they are, but rather because she is a woman in public life who is believed to have personal views that some maintain should be unacceptable for a woman in public life to have. Such penalization is a matter of the greatest concern to me because it represents a new glass ceiling for women jurists. And they have come too far to suffer now having their feet bound up just as they approach the tables of our high courts after long-struggling careers. I am deeply concerned that such treatment will have a chilling effect on women jurists that will keep them from weighing in on exactly the sorts of cases that most invite their participation and their perspectives as women. The truth is that Justice Owen has never written or said anything critical of abortion rights. In fact, the cases she is challenged on have everything to do with the rights of parents to be involved in their children's lives, and nothing to do with the right to an abortion. Ironically, the truth is that the cases that her detractors point to as proof of apparently unacceptable personal views are a series of fictions. This is what I mean about exposing the misstatements of the left-wing activist groups in Washington. I will illustrate just three of these fictions. The first sample fiction is the now often-cited comment attributed to then Texas Supreme Court Justice Alberto Gonzales, written in a case opinion, that Justice Owen's dissent signified ``an unconscionable act of judicial activism.'' Someone should do a story about how often this little shibboleth has been repeated in the press and in several websites of the professional smear groups. The problem with it is that it isn't true. Justice Gonzales was not referring to Justice Owen's dissent, but rather to the dissent of another colleague in the same case. The second sample fiction is the smear group's misrepresented portrayal of a case involving buffer zones and abortion clinics. In that case, the majority of the Texas Supreme Court ruled for Planned Parenthood and affirmed a lower court's injunction that protected abortion clinics and doctor's homes and imposed 1.2 million dollars in damages against pro-life protestors. In only a few instances, the court tightened the buffer zones against protestors. Justice Owen joined the majority opinion and was excoriated by dissenting colleagues, who were, by that way, admittedly pro-life. When describing that decision then, abortion rights leaders hailed the result as a victory for abortion rights in Texas. Planned Parenthood's lawyer said the decision ``isn't a home run, it's a grand slam.'' Of course, that result hasn't changed, but the characterization of it has. This is how Planned Parenthood describes this same case in their fact sheet on Justice Owen: ``[Owen] supports eliminating buffer zones around reproductive health care clinics . . .'' In fact, her decision did exactly the opposite. The third and most pervasive sample fiction concerns Justice Owen's rulings in a series of Jane Doe cases which first interpreted Texas' then-new parental involvement law. The law, which I think is important to emphasize was passed by the Texas legislature, not by Justice Owen, with bipartisan support, requires that an abortion clinic give notice to just one parent 48 hours prior to a minor's abortion. Unlike States with more restrictive laws such as Massachusetts, Wisconsin, and North Carolina, consent of the parent is not required in Texas. A minor may be exempted from giving such notice if they get court permission. Since the law went into effect, over 650 notice bypasses have been requested from the courts. Of these 650 cases, only 10 have had facts so difficult that two lower courts denied a notice bypass, only 10 have risen to the Texas Supreme Court. Justice Owen's detractors would have us believe that in these cases, she would have applied standards of her own choosing. Ironically, in each and every example they cite, whether concurring with the majority or dissenting, Justice Owen was applying not her own standards but the standards enuniciated in the Roe v. Wade line of decisions of the United States Supreme Court, which she followed and recognized as authority. For example, detractors take pains to tell us that Justice Owen would require that to be sufficiently informed to get an abortion without a parent's knowledge, that the minor show that they are being counseled on religious considerations. They appear to think this is nothing more than opposition to abortion rights. They are so bothered with this religious language that various documents produced by the abortion industry lobby italicize the word religious. But this standard is not Justice Owen's invention, but rather the words of the Supreme Court's pro-choice decision in Casey. Should she not follow one Supreme Court decision, but be required to follow another? Is that what we want our judges to do, pick and choose which decisions to follow? That appears to be the type of activist judge these groups want, and this Senate should resist all such attempts. The truth is that rather than altering the Texas law, Justice Owen was trying to effect the legislator's intent. No better evidence of this is the letter of the pro-choice woman Texas Senator stating her ``unequivocal'' support of Justice Owen. Senator Shapiro says of Justice Owen: ``Her opinions interpreting the Texas [parental involvement law] serve as prime example of her judicial restraint.'' I understand why the Washington left-wing groups don't like that in a judge, but the Senate and the Judiciary Committee should applaud and commend such restraint and temperament. The truth is that, rather than being an activist foe of Roe, Justice Owen repeatedly cites and follows Roe and its progeny as authority. She has to, it's what the Court has said is the law. Compare this to Justice Ruth Bader Ginsburg who wrote in 1985 that the Roe v. Wade decision represented ``heavy handed judicial intervention'' that was ``difficult to justify.'' In relation to this, I would like briefly to comment on the mounting offensive of some to change the rules of judicial confirmation by asking nominees to share personal views or to ensure that nominees share the personal views of the Senator on certain cases. To illustrate my view, I'll tell you that many people have recently called on the Judiciary Committee to question nominees as to their views on the pledge of allegiance case. My full-throated answer to this is no, as much as I think that that case was wrongly decided. I also happen to think that the recent School Voucher case is the most important civil rights decision since Brown but I am not going to ask people what they think about that case either. Such questions threaten the heart of the independent judiciary and attempt to accomplish by hidden indirection what Senators cannot do openly by constitutional amendment. It is an attempt to make the courts a mere extension of the Congress. I speak against this practice in the strongest terms, and, in my view, any nominee who answers such questions would not be fit for judicial office and would not have my vote. The truth is that there are many who, like Justice Ginsburg, think that cases like Griswold or Roe were wrongly decided as a constitutional matter even if they agree with the policy result, just as the great liberal Justice Hugo Black did in his dissent in Griswold. A few weeks ago we heard testimony from Boyden Gray, a former White Counsel and a former Supreme Court clerk, that Chief Justice Warren though that Brown v. Board of Education was his worst ruling as matter of constitutional law, but not his least necessary to end desegregation. Some of Justice Owen's detractors have made much about the fact that she is not afraid to dissent. Of course, they fail to mention dissents like her opinion in Hyundai Motor v. Alvarado, in which Justice Owens' reasoning was later adopted by the United States Supreme Court on the same difficult issue of law. They also overlooked here dissent in a repressed memory/sexual abuse case where she took the majority to task with these words: ``This is reminiscent of the days when the crime of rape went unpunished unless corroborating evidence was available. The Court's opinion reflects the attitudes reflected in that era.'' Perhaps, they thought that this dissent showed her too representative of American women. Despite deceptive opposition I think that Justice Owen should be confirmed. I will ask unanimous consent to place into the Record an editorial of earlier this week from The Washington Post, a liberal publication, calling on us to be fair and calling on this Senate to confirm Justice Owen. I have hope that my Democrat colleagues on the Judiciary Committee will be led by the time-tested standards well-stated by Senator Biden, and look again to qualifications and judicial temperament, not base politics. Whether the Biden standard will survive past our time, will be tested now. If we fail the test we will breach our responsibility as auditors of the Washington special interest groups and the Judiciary's stewards on behalf of all the people, and not just some. Mr. President, I ask unanimous consent that the documents to which I have referred be printed in the Record.