Orrin Hatch

Mr. HATCH

Mr. HATCH. Today I rise and join Senators Campbell, Leahy, Reid, and others I have named on this bill to offer it as an amendment to S. 1805, the Law Enforcement Officers Safety Act of 2003, which was favorably reported out of the Judiciary Committee with strong bipartisan support last session. This amendment, which permits qualified current and retired law enforcement officers to carry a concealed firearm in any jurisdiction, will help protect the American public, our Nation's officers, and their families. I would note this bill has the overwhelming support of the Fraternal Order of Police and other law enforcement associations which have vigorously worked in support of this measure. This amendment allows qualified law enforcement officers and retired officers to carry, with appropriate identification, a concealed firearm that has been shipped or transported in interstate or foreign commerce regardless of State or local laws. Importantly, this legislation does not supersede any State law that permits private persons to prohibit or restrict possession of firearms on any State or local government properties, installations, buildings, bases, or parks. Additionally, this amendment clearly defines what is meant by ``qualified law enforcement officer'' and ``qualified retired or former law enforcement officer'' to ensure those individuals permitted to carry concealed firearms are highly trained professionals. This amendment will not only provide law enforcement officers with the legal means to protect themselves and their families when they travel interstate, it will also enhance the security of the American public, which is long overdue. By enabling qualified active duty and retired law enforcement officers to carry firearms, even if off duty, more trained law enforcement officers will be on the street to enforce the law and to respond to any crises that may arise. I urge my colleagues to vote in favor of this amendment because passage of this important legislation will provide that extra layer of protection to current and retired law enforcement officers, their families, and the public that we so desperately need. Mr. President, I appreciate the cosponsors on this bill, which includes Senator Reid. I ask unanimous consent that Senator Reid be added as a cosponsor.

Mr. HATCH. I yield the floor.

Mr. HATCH

Mr. HATCH. I rise today in support of S. 1805, the Protection of Lawful Commerce in Arms Act. This critically important bipartisan legislation will block baseless lawsuits initiated by individuals who wish to drive out of business a lawful and legitimate business, the American firearms industry. This bill will halt lawsuits that are nothing more than shameless attempts to advance a stalled anti-gun legislative agenda and a flagrant abuse of the judicial system. I commend my colleague, Senator Larry Craig, and other cosponsors from both sides of the aisle, over 50 of them, for their hard work to get this bill to the Senate floor. As my colleagues are aware, I have long been a proponent of legislation that addresses the growing problem of lawsuit abuse. The issues addressed by this legislation will remedy one such class of shameless and abusive lawsuits. I am hopeful this will be the first of many other reform measures that the Senate will take up before the end of the 108th Congress. This includes asbestos reform that would save this country, save jobs, provide jobs, for hundreds of thousands of people; bankruptcy, which also would save jobs that our friends on the other side seem to be stopping; and class action reform, which in the end would save jobs. As I mentioned, this legislation has broad bipartisan support, including from the minority leader. I agreed with my colleague, Senator Daschle, when he quite accurately stated: It is wrong, and it is a misuse of the civil justice system, to try to punish honest, law-abiding people for illegal acts committed by others without their knowledge or involvement. That's not the way we do things in America. We do not hold innocent people responsible for acts they are not involved in and over which they have no control. I commend Senator Daschle. He could not have said it better. I call these lawsuits shameless because the trial lawyers who bring them--and they are really personal injury lawyers, by and large, who bring them-- dislike and attack a product that is produced and marketed legally. What is going on is simply outrageous. It is as absurd as suing a car manufacturer for drunken driving accidents or suing a fast food company because a hamburger has more calories than it should. We must put a stop to these senseless lawsuits before our legal system grinds to a halt. The need for legislation of this type is imperative. This legislation will prohibit civil liability actions against the firearms industry for damages resulting from the misuse of its products by others; that is, meritless lawsuits based on lawful products that are intentionally misused are prohibited by this bill. Now, anybody who thinks ought to agree with that. In product liability cases, plaintiffs traditionally have been able to sue for compensation for injuries because, No. 1, a product was defective; No. 2, the defect posed an unreasonable danger to the user; and No. 3, the defect caused the injury. A ``defective product'' is one that does not operate as a reasonable manufacturer would design and make it, as a reasonable consumer would expect, or as other products of its type. Courts uniformly have held that a defect must exist in the product at the time it was sold and that a plaintiff's injury must have been the result of that defect. However, in the firearms context, gun manufacturers and dealers are potentially liable for injuries that occur because their properly operating product is criminally or negligently misused. Now, this is unacceptable. I would also like to take this opportunity to make clear that this legislation does not relieve from liability gunmakers who create defective products or gun dealers who negligently sell weapons when they know or should have known that such a weapon would be used in a crime. Additionally, this legislation contains the following significant safeguards: One, an action brought against a transferor convicted for transferring a firearm knowing it would be used in a crime of violence or drug trafficking crime by a party directly harmed by the conduct of which the transferee is so convicted; No. 2, an action brought against a seller for supplying a firearm or ammunition to another person when one knows or should know that person is likely to and does use the product in a manner involving unreasonable risk of physical injury to the person and others for negligence per se; No. 3, an action in which a manufacturer or seller violated a State or Federal statute applicable to the sale or marketing of the product and the violation was the proximate cause of the harm for which relief was sought; No. 4, an action for breach of contract or warranty in connection with the purchase of a product; or No. 5, an action for physical injuries or property damage resulting directly from a defect in design or manufacture of the product when used as intended or in a manner that is reasonably foreseeable. Now, because this bill strikes the right balance between protecting the general public and those who manufacture a lawful product, I strongly support the legislation, and I urge all of my colleagues to do the same. We all know what is involved. We know the personal injury lawyers are going to sue just about anybody against whom they are able to conjure up a theory of liability, and hope that some of the irresponsible judges in this country will allow those cases to go to the jury. Then on appeal, they hope irresponsible appellate lawyers and activist judges, will ignore the law, ignore every basic instinct of the law, and allow those lawsuits to go forward. And they hope their friends on the Supreme Court will ignore the law as well and through activism do whatever they believe is right, as many of the judges on the Ninth Circuit Court of Appeals do every day. They ignore the law completely, do whatever their gut tells them ought to be done, even though most of the time their gut is filled with legalistic ulcers. The fact is, that is not the way the law should run. That is not the way it should operate. Lawyers should be ashamed to bring these type of cases. In this particular bill, we protect the consuming public and others from irresponsible misuse of firearms. We protect them from irresponsibility on the part of any gun manufacturer. That needs to be said, and it needs to be said over and over. The fact is, what we have is a lot of very liberal thinkers who think that guns should not be owned by anybody, or they should be owned only by a few--I guess those who have been to some sort of anti-gun college. The fact is, most Americans own guns, most Americans value guns, most Americans believe in protecting themselves and their families. Where we have the most guns, that is where we have the lowest amount of crime. Everybody knows I have brought a bill to the Senate to allow guns to be kept in the home in the District of Columbia, which many refer to as Murder Capital USA. I don't want to bring that up as an amendment on this. I might have to, if some of these irresponsible amendments filed pass. We know the only way this bill is going to make it to the President's signature is if it doesn't have any other amendments on it. But if any others pass, I think we ought to vote on that one as well. Because, to be honest with you, I have had hundreds of DC residents call me and say thank God somebody is acting in our interests, where we can at least protect our homes. That is how bad it is. We have people who just don't believe in guns, don't believe in sportsmanship, don't believe in the right to collect guns, who are going to be against them for political reasons because they think there are political advantages for them. Frankly, I think they are going to find there are not any political advantages for them because most people in our country believe in the right to have their own arms. Most people hunt and fish. Most people are proud of the fact they can take their young boys or girls out and have target practice and shoot guns. The fact is, the vast majority, the highest percentile in the world, use guns responsibly in this country. For those who do not, I am for coming down very hard against them. For those who misuse guns in the commission of crimes, you can't get any tougher on crimes than Orrin Hatch is. Frankly, we passed legislation around here, anti-crime legislation, Senator Biden and myself and others, that literally goes hard on those who use and misuse weapons and use them in criminal activity. That is what we should be doing. But we certainly ought not to allow spurious, frivolous lawsuits brought against gun manufacturers who have done nothing wrong other than make guns the American people would like to own. With that, I don't mean to demean anybody on the floor. All I can say is that for the life of me, I can't understand why anybody would be against this bill who understands the law and understands the way the law should be applied. Frankly, I am amazed that some are. There were 22 who voted against cloture this morning. That was unbelievable. The fact of the matter is, cloture should have been invoked 100 to zip, but that is how far this issue has denigrated, to the point where it is just a political issue in the eyes of some. It is time to get rid of the politics and understand the American people are not going to put up with that kind of stuff, and they should not. The law should not be used in the frivolous fashion some of these personal injury lawyers use it. There are a lot of great personal injury lawyers out there and there are a lot of great trial lawyers who do what is right and who would not think for a minute of bringing these frivolous lawsuits against gun manufacturers who are not responsible for the misuse of their weapons. When they are irresponsibly brought, this bill takes care of them. It says you are going to pay for it. But when they are not responsible for the misuse of their weapons, why in the world would we allow litigation to be brought, just because the trial lawyers might support us? There is a certain point where any good thinking person has to say: Look, the law is more important than just emotion. Unfortunately, most of the arguments used against this bill are emotional arguments that really have no place in the area of law. Frankly, they should not be paid very much attention. I yield the floor.

Mr. HATCH

Mr. HATCH. Mr. President, I ask unanimous consent that Patrick Shen and Brett Tolman, detailees on the Judiciary Committee staff, be granted the privileges of the floor for the duration of this session.

Mr. HATCH

Mr. HATCH. Mr. President, what is the state of business?

Mr. HATCH. Thank you, Mr. President. I rise to speak in support of S. 2061, the Healthy Mothers and Healthy Babies Access to Care Act. This bill addresses the medical liability and litigation crisis in our country, a crisis that is preventing patients from receiving high quality health care--or, in some cases, any care at all because doctors are being driven out of practice. This crisis is limiting or denying access to vital medical care and needlessly increasing the cost of care for every American. As you will recall, we have previously tried to remedy this crisis in access to care. Most recently, we debated S. 11 which failed to receive the 60 votes necessary to invoke cloture last July. You have to have a supermajority now on these types of issues because of the opponents of this bill--and some others. The time to act is now. The health care crisis is jeopardizing access to health care for many Americans. The medical liability crisis is also inhibiting efforts to improve patient safety and is stifling medical innovation. Excessive litigation is adding billions of dollars in increased costs and reduced access to high quality health care. Defensive medicine is way out of whack. We are spending billions of dollars on unnecessary defensive medicine because doctors are terrified they are going to be sued in these frivolous lawsuits--called medical liability suits--by personal injury lawyers. I am deeply concerned that we are needlessly compromising patient safety and quality health care. We know about 4 percent of hospitalizations involve an adverse event, and 1 percent of hospitalizations involve an injury that would be considered negligent in court. These numbers have been consistent in large studies done in New York, California, Colorado, and in my home State of Utah. However, the equally troubling statistic is only 2 percent of cases with actual negligent injuries result in claims, and less than one-fifth--17 percent--of claims filed actually involve a negligent injury. This situation has been likened to a traffic cop who regularly gives out more tickets to drivers who go through green lights than those who run red lights. Clearly, nobody would defend that method of ensuring traffic safety, and we should not accept such an insufficient and inequitable method of ensuring patient safety. Numbers are a searing indictment of the current medical liability system. I personally believe we can do better for the American people, and the Healthy Mothers and Babies Act is an important step in that path. The problem is particularly acute for women who need obstetrical and gynecologic care because OB/GYN is among the top three specialties with the highest professional liability insurance premiums. This has led to many doctors leaving practice and to a shortage of doctors in many States, including my home State of Utah. 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. Over half--50.5 percent--of family practitioners in Utah have already given up obstetrical services or never practice 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 5 years. An ACOG survey from August 2002 revealed that over half--53.16 percent--of OB/GYNs in Utah have changed their practice, such as retiring, relocating, or dropping obstetrics because of the medical liability reform crisis. This change in practice leaves 1,458 pregnant Utahns without OB/GYN care. The medical liability crisis, while affecting all medical specialties and practices, hits OB/GYN practices especially hard, and I suspect this is true of every State in the Union. Astonishingly, over three- fourths, 76.5 percent, of obstetricians/gynecologists report being sued at least once in their career. Indeed, over one-fourth of OB/GYN doctors will be sued for care given during their residency. These numbers have discouraged Americans finishing medical school from choosing this vital specialty. Currently, one-third of OB/GYN residency slots are filled by foreign medical graduates compared to only 14 percent one decade ago. OB/GYN doctors are particularly vulnerable to unjustified lawsuits because of the tendency to blame the doctor for brain-injured infants, although research has proven that physician error is responsible for less than 4 percent of all neurologically impaired babies. Ensuring the availability of high-quality prenatal and delivery care for pregnant women and their babies, the most vulnerable members of our society, is imperative. We simply must pass this bill. In August 2003, a GAO report concluded that actions taken by health providers as a result of skyrocketing malpractice premiums have contributed to health care access problems. These problems include reduced access to hospital-based services for deliveries, especially in rural areas. In addition, the report indicated that States that have enacted tort reform laws with caps on noneconomic damages have slower growth rates in medical malpractice premiums and claims payments. From 2001 to 2002, the average premiums for medical malpractice insurance increased about 10 percent in States with caps on noneconomic damages. In comparison, States with more limited reforms experienced an increase of 29 percent in medical malpractice premiums. Medical liability litigation directly and dramatically increases health care costs for all Americans. Unfortunately, a high percentage of those cases are brought in order to get the defense costs by, in many respects, lawyers who are not true to their profession, who are personal injury lawyers seeking to make a buck. In addition, skyrocketing medical litigation costs indirectly increase health care costs by changing the way doctors practice medicine. Defensive medicine is defined as medical care that is primarily or solely motivated by fear of malpractice claims and not by the patient's medical condition. According to a survey of 1,800 doctors published in the Journal of Medical Economics, more than three-fourths of doctors believed they must practice defensive medicine. A 1998 study of defensive medicine by Mark McClellan, our current head of the FDA who has been nominated now to be head of CMS, used national health expenditure data that showed medical liability reform has the potential to reduce defensive medicine expenditures by $69 billion to $124 billion in 2001, an amount that is between 3.2 and 5.8 times the amount of malpractice premiums. The financial toll of defensive medicine is great and especially significant for reform purposes as it does not produce any positive health results nor benefits. Not only does defensive medicine increase health care costs, it also puts Americans at avoidable risk. Nearly every test and every treatment has possible side effects. Thus every unnecessary test, procedure, and treatment potentially puts a patient in harm's way. Seventy-six percent of physicians are concerned that malpractice litigation has hurt their ability to provide quality care to patients. What can we do to address this crisis? The answer is plenty. There are excellent examples of what works. Last March, the Department of Health and Human Services released a report describing how reasonable reforms in some States have reduced health care costs and improved access to quality health care. More specifically, over the last 2 years in States with limits of $250,000 to $350,000 on noneconomic damages, premiums have increased an average of just 18 percent, compared to 45 percent in States without such limits. California enacted the Medical Injury Compensation Reform Act, also known as MICRA, more than a quarter century ago. MICRA slowed the rate of increase in medical liability premiums dramatically without affecting negatively the quality of health care received by the State's residents. As a result, doctors are not leaving California. Furthermore, between 1976 and 2000, premiums increased by 167 percent in California, while they increased three times as much, 505 percent, in the rest of the country. Consequently, Californians were saved billions of dollars in health care costs, and Federal taxpayers were saved billions of dollars in the Medicare and Medicaid programs. No one in this body, perhaps with the exception of our colleague from Tennessee, Dr. Bill Frist, our majority leader, is more keenly aware of the defects in this system than I. Before coming to Congress, I litigated several medical liability cases. I defended health care providers. I have seen the heart-wrenching cases in which mistakes were made and where judgments should have been brought. But more often I have seen 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 seen a lot of cases where there was no injury at all that were brought by unscrupulous personal injury lawyers, running up the cost to all the doctors, to the whole system. A high percentage of these cases are brought merely for defense costs because it cost so much to defend these cases that even the defense costs mean a pretty good fee if you are charging 30 to 40 percent. The recent Institute of Medicine report, ``To Err is Human,'' concluded that ``the majority of medical errors do not result from individual recklessness or the actions of a particular group. This is not a bad apple problem. More commonly, errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them''. We need reform to improve the health care systems and processes that allow errors to occur and to identify better when malpractice has not occurred. The reform I envision would address litigation abuses in order to provide swift and appropriate compensation for malpractice victims, redress for serious problems, and ensure that medical liability costs do not prevent patients from accessing the care they need. We need to move ahead with legislation to improve patient safety and reduce medical errors, and we need urgently to address the medical liability crisis so that more women are not denied access to quality medical care because it has become too expensive for their OB/GYN doctors to continue their practice. The Healthy Mothers and Healthy Babies Access to Care Act will allow us to begin ensuring women and babies get the medical care they need and deserve. Without tort reform, juries are awarding astounding and unreasonable sums for pain and suffering. A sizable portion of those awards goes to the attorney rather than to the patient. The result is that doctors cannot get insurance and patients cannot get the care they need and deserve. All Americans deserve the access to care, the cost savings, and the legal protections that States such as California provide their residents. Today's bill will allow us to begin to address this crisis in our health care system, gives women and their babies access to their OB/GYN doctors, and enables doctors to provide high-quality, cost- effective medical care. I strongly support this legislation and urge my colleagues to support cloture. I yield the floor.

Mr. HATCH

Mr. HATCH. Mr. President, these truly are ``the times that try men's souls'' and challenge our resolve as a Nation. Today, it is with profound regret that I stand to pay tribute to a true patriot of liberty who gave his life so that others may live in freedom. His name was Juan C. Cabralbanuelos and he was a soldier in the U.S. Army. Many have stood in this chamber to reflect on the loss that our Nation has felt and the price that it has paid to remain free. Today, I stand to remember one who was a citizen of another nation, one who loved the United States and freedom so much, he was willing to give his life to preserve an idea: freedom. He truly deserves the honor of being called an American patriot. Coporal Cabralbanuelos leaves behind a wife Anita and two sons ages seven and one. To them, I know that nothing that I say here will temper your grief. But know this: your loss will not go unnoticed and unrecognized, your fellow Americans now and always will stand behind you and support you through the trying times ahead. And so another name has been added to Utah's List of Honor: Corporal Juan Carlos Cabralbanuelos. He joins an illustrious list that includes Specialist David J. Goldberg, US Army Reserve; Captain Nathan S. Dalley, West Point graduate and a member of the Army's 1st Armored Division; staff Sergeant James W. Cawley, United States Marine Corps Reserve; Staff Sergeant Nino D. Livaudais of the Army's Ranger Regiment; Randall S. Rehn, of the Army's 3rd Infantry Division; Sergeant Mason D. Whetstone of the United States Army; and former Special Forces soldier Brett Thorpe. Their names and the service they performed is something that I shall never forget. I shall always honor them and their families.

Mr. HATCH

Mr. HATCH. Madam President, I rise today in support of our nominee to the U.S. District Court of the Northern District of New York, Gary L. Sharpe. Judge Sharpe graduated magna cum laude from Buffalo University in 1971 where he was a member of Phi Beta Kappa. Three years later, he graduated from Cornell Law School. Judge Sharpe had a distinguished legal career prior to his appointment as a Federal magistrate judge for the Northern District of New York in 1997. He had been an Assistant Broome County District Attorney in Binghamton, a special assistant New York Attorney General in Syracuse, a supervisory Assistant U.S. Attorney, and the interim U.S. Attorney for the Northern District of New York. Judge Sharpe is also a Vietnam veteran, having served our country in both the U.S. Army and Navy. Judge Sharpe has a wealth of experience that will serve him well on the Federal bench. I am very confident that he will make an excellent Federal judge. I commend President Bush for nominating him, and I urge my colleagues to join me in supporting his nomination. Thank you, Mr. President. I yield the floor.

Mr. HATCH. I ask for the yeas and nays.

Mr. HATCH

Mr. HATCH. Mr. President, I rise today to discuss the sections of the consolidated Appropriations bill, H.R. 2673, that pertain to funding for the Departments of Commerce, Justice, and State. I want to recognize the conferees, especially CJS Appropriations Chairman Gregg and ranking minority member Hollings for their hard work on this bill. It has been just over 2 years since the horrific September 11 attack against our country. We must remain vigilant in fighting the threat of terrorism. Our priorities should reflect the need to ensure the security of our people. The Justice Department leads our Federal law enforcement efforts that are so critical to protecting our country. Securing the safety and security of Americans at home and abroad should continue to be the number one priority in the Federal law enforcement budget. Such security requires providing Federal law enforcement agencies, as well as State and local law enforcement agencies, with the tools necessary to combat terrorism. Providing adequate funding for these tools is essential to law enforcement's ability to protect America. I am pleased that the Omnibus appropriations bill reflects this priority. While we must continue to safeguard America from future terrorist attacks, we should, at the same time, exercise fiscal discipline in order to promote our economy. We face difficult budget decisions but I am optimistic that with the improving economy we can balance the need to fund fully the programs necessary to protect Americans with the continuing need to exercise the fiscal discipline that our constituents deserve. I am especially pleased that approximately $62 million will be appropriated to the Foreign Terrorist Tracking Task Force FTTTF. This independent agency is responsible for coordinating and sharing information among agencies which is crucial to preventing terrorist attacks. The FTTTF is tasked with an enormous responsibility--gathering information from and sharing intelligence with--the CIA, the FBI, the National Security Agency and the Departments of Justice, Homeland Security, Treasury, State and Defense. Breaking down the walls between our agencies is critical to our national security, and I applaud the increase in funding for the Foreign Terrorist Tracking Task Force. While our Federal law enforcement agencies have focused on combating terrorism, they also carry the burden of investigating and prosecuting other significant crimes. I am pleased to see that the bill includes almost $557 million for Interagency Drug Enforcement which reflects funding for the multiple Departments, including the Department of Homeland Security, the Department of Treasury, and the Department of Justice, which are responsible for cooperating and bringing together the expertise of each of the Federal agencies with the efforts of state and local law enforcement to combat major narcotics traffickers and money launderers. This represents a significant increase to assist law enforcement operations. I am especially pleased that the Conferees accepted the House funding levels for the Drug Enforcement Administration, DEA at approximately $2.2 billion rather than the Senate's level which would have severely hampered the DEA. At a time when the DEA is shouldering a greater burden in fighting drug trafficking, I commend the Senate for increasing the DEA's funding to make sure that our communities receive all the help they can to reduce the scourge of drugs. I am also pleased to see that the bill funds the Juvenile Accountability Block Grant, JABG, program which was recently reauthorized as part of the ``21st Century Department of Justice Appropriations Authorization Act,'' P.L. 107-273. Congress reformed the federal role in the nation's juvenile justice system by providing relief from burdensome federal mandates and authorizing block grant assistance to States and local governments, which includes accountability-based juvenile justice programs. The authorization act strengthened the Juvenile Accountability Incentive Block Grant program. With the passage of Trade Promotion Authority in 2002, Congress set, as one of its priorities, the successful negotiation of free trade agreements. As many of my colleagues are aware, the burden of negotiating these agreements falls on the Office of the United States Trade Representative, USTR. I submit that in order for USTR to do its job, we must ensure that they have the adequate resources necessary to perform the job that we demand of the agency. Let's examine some of the realities at USTR. One year prior to the passage of TPA, USTR's workload was comprised of two trade agreements. One year after the passage of TPA, USTR's has taken on more than five times its prior workload, negotiating nearly a dozen Free Trade Agreements and pursuing several dispute settlement talks. And the complexities of the negotiations before and after the passage of TPA have changed. Under the mandates of TPA, through the course of negotiating any Free Trade Agreement, U.S. negotiators seek: strong Intellectual Property Rights protections; access to telecommunications markets; access to financial markets; strong biotechnology protections; increased access to the services markets; strong investment protections; reasonable labor protections; common sense environmental protections; access to the e-commerce market; to ensure the safety of imported food; and strong dispute settlement mechanisms that help to protect America's economic interests. This is no small feat. I am pleased that the conferees accepted the House level of funding to this important agency which provided an additional $5 million-- bringing USTR's funding to $41,994,000. This additional funding is consistent with the marked increase in the agency's workload and will help ensure that USTR will be able to adequately fulfill their Congressional mandate. I was hoping to see language in the bill which would ask the General Accounting Office, GAO, to look into several issues that will be relevant in the preparation of the 2010 census. What I would have liked to see could have been as simple as the following: the potential cost of any 2010 Overseas Census; the use of emerging technologies, including the internet, in any overseas enumeration; the feasibility of using State or Federal systems for assigning Americans living outside of the United States for purposes of appointment of Representatives in Congress among the several states; and the different ways of determining some legal basis for whom should be counted. These are important issues that need to be more fully explored. In my State of Utah, where some 14,000 Utah residents are serving an overseas mission for the Church of Jesus Christ of Later Day Saints and are not counted in any census--this is an especially critical issue. I submit that these four issues are not only important for Utahns but for the nation as a whole. There are many citizens of this great Nation that are either temporarily living or working overseas that are not counted in the decennial census. The Congress needs to identify the best and most cost effective ways to ensure that every citizen is counted. I would have also liked this bill to correct a provision enacted in Section 211 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999. That section was challenged before the WTO following its application in a U.S. lawsuit addressing the enforceability of a trade name confiscated by the Cuban government in 1960 without compensation to the owner. The court found the trademark to be unenforceable by the plaintiff entity, which had acquired the alleged rights to the mark from the Cuban government. Congress should bring the United States into compliance with the decision of the WTO Appellate Body in that case. The WTO found in favor of the United States on the section 211 challenge in all respects but one: it concluded that section 211 was drafted in a manner that transgressed the national treatment and most- favored-nation obligations under the TRIPS agreement. At issue was the language of section 211 specifying that the Cuban Government, Cuban nationals and their non-U.S. successors are ineligible to own, and therefore enforce, confiscated trademarks. We should clarify that the prohibition on owning trademarks confiscated in Cuba applies to all nationals, not just Cuban nationals and their successors, thus removing the basis of the WTO's criticism. While I urged the chairman and ranking Democratic member of the Appropriations Committee to look seriously at including this language in the bill to correct previous appropriations language, I do want to make it clear that it does not constitute a waiver of the Judiciary Committee's jurisdiction over this or any related matter. Again, I want to thank the Conferees for their efforts. Mr. INHOFE. Mr. President, I would like to remark briefly on a matter of critical importance to me, related to one of the bills included in this omnibus, VA-HUD. The Senate Committee on Appropriations' Report on VA-HUD contains language directing the Agency for Toxic Substances and Disease Registry--ATSDR--to assess the lead levels at the Tar Creek Superfund site in Oklahoma, and to submit a report to Congress on this assessment no later than July 31, 2004. As a Senator from Oklahoma, and as the chairman of the Environment and Public Works Committee, I cannot emphasize enough the importance of this endeavor to more fully understand the elevated lead levels we're seeing in this community, particularly in children. As the chairman of the committee with jurisdiction over both Superfund and ATSDR, I would like to take this opportunity to elaborate on my expectations of ATSDR in connection with this directive: I am urging ATSDR, in collaboration with the Oklahoma State Health Department, to work to identify significant sources and pathways of exposure to lead that may be contributing to elevated blood lead levels in children at the Tar Creek Superfund site in Oklahoma.

Mr. HATCH

Mr. HATCH. Madam President, I am pleased to inform my colleagues that we have reached an agreement on final language for S. 1177, the Prevent All Cigarette Trafficking, PACT Act of 2003, which my friend Senator Kohl and I introduced on June 3, 2003. The manager's amendment makes the PACT Act even stronger than as introduced. The distinguished Senator from Wisconsin and I originally introduced the PACT Act because of our concern that contraband cigarette trafficking both damages the economies of several States and contributes heavily to the profits of organized crime syndicates, including global terrorist organizations. When we reported this bill from the Judiciary Committee on July 31, 2003, I pledged to work with my colleagues on both sides of the aisle to address any and all concerns they had with the legislation. The result of this bipartisan effort is a piece of legislation that will prevent cigarette and smokeless tobacco smuggling and ensure the collection of tobacco excise taxes without infringing upon the rights of Native Americans or consumers. Internet sales of cigarettes and smokeless tobacco are an impediment States face in their collection of tobacco excise taxes. A recent General Accounting Office report indicates Internet tobacco sellers rarely comply with requirements under the Jenkins Act of 1949 (15 U.S.C. Sec. Sec. 375-378 (2003)). The Jenkins Act, as modified by this legislation, is a Federal statute that requires tobacco retailers to register with the tax authority for each State in which they sell cigarette and smokeless tobacco products and to file monthly reports providing shipment information within each state. Failing to comply with the Jenkins Act damages not only individual States, but also retailers that are put in unfair commercial disadvantage. By ensuring the collection of state excise taxes from all tobacco retailers, the PACT Act will neither inconvenience nor hinder smokers and smokeless tobacco users in their ability as consumers to purchase the tobacco products of their choice over the Internet. This legislation merely removes any uncertainty regarding the scope of the Jenkins Act by explicitly mandating Internet tobacco retailers also comply with existing requirements under the Jenkins Act. This strong vehicle with which to collect taxes from Internet tobacco retailers will allow States to finally claim their rightful revenue and level the playing field for all tobacco retailers. The PACT Act as modified by the manager's amendment also clarifies that the bill will not affect existing tribal compacts relating to tobacco tax collection on tribal lands and allows Native American Tribes to maintain enforcement authority over their own excise tax laws. As I mentioned in June, law enforcement authorities have uncovered several instances in which organized crime syndicates are illegally funding terrorist organizations, such as Lebanon-based Hezbollah, through the smuggling of cigarettes. These groups purchase cigarettes in States with low taxes and then transport them into states with higher taxes where the contraband is sold to small retailers at below market costs. The September 19, 2003, edition of the Detroit Free Press reports that one such scheme involved a 12-member syndicate, which purchased cigarettes in North Carolina and resold them in Michigan. Because North Carolina collects a 50-cent-per-carton tax and Michigan collects a $12.50 per carton tax, federal prosecutors estimated that one member of the scheme, Hassan Moussa Makki, who monthly smuggled $36,000 to $72,000 worth of cigarettes into the State during a 2-year- period, prevented Michigan from collecting $2 million in tax revenue. Law enforcement authorities determined Makki donated a substantial portion of these profits to Hezbollah. By providing state attorneys general with the necessary enforcement tools and the Bureau of Alcohol, Tobacco, Firearms and Explosives with investigative and inspection authority, the PACT Act will ultimately disrupt this form of terrorist funding and ensure that state, local and tribal governments collect their rightful excise taxes from both cigarette and smokeless tobacco sales. With respect to delivery sales of smokeless tobacco, this provision is intended to impose strict federal limitations on delivery sales in order to supplement, and not preempt, applicable State or local law. Accordingly, it is intended that State-specific requirements in connection with the collection and remittance of applicable smokeless tobacco excise taxes will remain controlling, notwithstanding that advance payment of excise taxes might otherwise be required by Federal law in the absence of contrary State law. Moreover, the Federal proscription of delivery sales of smokeless tobacco with respect to which excise taxes have not been paid in advance of the delivery is not intended to apply where the laws or administrative practices of the State and locality in which the delivery is made provide that the delivery seller may remit applicable smokeless tobacco excise taxes in an alternate manner. For example, the law of the delivery State and locality may explicitly or implicitly provide for the payment of smokeless tobacco excise taxes along with the filing of a tax return in the month subsequent to the delivery sale. Under such circumstances, even though applicable State or local law may not require the applicable smokeless tobacco excise taxes be remitted after the delivery, where the law of the delivery State and locality allows for such taxes to be remitted after the delivery, the intent of this provision is that the delivery sale may be made without violating federal law provided that applicable State and local law with respect to the collection and/or remittance of applicable smokeless tobacco excise taxes are satisfied. I call upon my colleagues to support Senator Kohl's and my efforts to prevent the funding of global terrorist organizations and ensure the collection of all excise taxes from the sale of cigarettes and smokeless tobacco, including Internet sales, so States can utilize their rightful revenue.

Mr. HATCH

Mr. HATCH. Mr. President, I rise today to introduce with my friend and colleague from Vermont, Senator Leahy, the Satellite Home Viewer Extension Act of 2004. We are pleased to be joined in this effort by Senators DeWine and Kohl. S. 2013 provides for a five-year extension of the statutory license for satellite carriers to make secondary transmissions of ``distant'' network and superstation television programs, which is set forth in section 119 of the Copyright Act. The current section 119 license permits satellite carriers to provide subscribers that reside in unserved households with network programming from distant television markets. This section is set to expire at the end of 2004. The extension of this statutory license for an additional five years would continue to serve the many interests that the section 119 license seeks to advance. Most importantly, it assures that television viewers incapable of receiving local network stations off the air retain access to network programming via satellite. This is particularly important for viewers who live in rural areas and may be unserved by either local stations or cable carriers. Indeed, many of my constituents in Utah depend on satellite systems for their television reception. This statutory license also enables the satellite home delivery industry to effectively compete with cable companies, which have long enjoyed a statutory license of their own. The limited extension also recognizes, however, that satellite carriers are still in the process of making local signals available to their subscribers, an important development for viewers and local broadcasters, as well as for the satellite carriers themselves. The Satellite Home Viewer Improvement Act of 1999, which I was proud to help draft, authorized for the first time the retransmission of local signals to satellite subscribers residing in those local markets. The roll-out of ``local-into-local'' service by satellite carriers continues at a substantial rate, giving subscribers more choices than ever and further strengthening the competition between cable and satellite carriers. In light of these continuing changes, an additional extension of the Section 119 license is warranted pending further developments in this area. I recognize that there are likely to be other issues relating to the section 119 license that warrant consideration in connection with this reauthorization. I look forward to working with my colleagues and hearing from the interested parties on those matters in the coming months.

Mr. HATCH

Mr. HATCH. Mr. President, I rise today to introduce with my friend and colleague from Vermont, Senator Leahy, the Satellite Home Viewer Extension Act of 2004. We are pleased to be joined in this effort by Senators DeWine and Kohl. S. 2013 provides for a five-year extension of the statutory license for satellite carriers to make secondary transmissions of ``distant'' network and superstation television programs, which is set forth in section 119 of the Copyright Act. The current section 119 license permits satellite carriers to provide subscribers that reside in unserved households with network programming from distant television markets. This section is set to expire at the end of 2004. The extension of this statutory license for an additional five years would continue to serve the many interests that the section 119 license seeks to advance. Most importantly, it assures that television viewers incapable of receiving local network stations off the air retain access to network programming via satellite. This is particularly important for viewers who live in rural areas and may be unserved by either local stations or cable carriers. Indeed, many of my constituents in Utah depend on satellite systems for their television reception. This statutory license also enables the satellite home delivery industry to effectively compete with cable companies, which have long enjoyed a statutory license of their own. The limited extension also recognizes, however, that satellite carriers are still in the process of making local signals available to their subscribers, an important development for viewers and local broadcasters, as well as for the satellite carriers themselves. The Satellite Home Viewer Improvement Act of 1999, which I was proud to help draft, authorized for the first time the retransmission of local signals to satellite subscribers residing in those local markets. The roll-out of ``local-into-local'' service by satellite carriers continues at a substantial rate, giving subscribers more choices than ever and further strengthening the competition between cable and satellite carriers. In light of these continuing changes, an additional extension of the Section 119 license is warranted pending further developments in this area. I recognize that there are likely to be other issues relating to the section 119 license that warrant consideration in connection with this reauthorization. I look forward to working with my colleagues and hearing from the interested parties on those matters in the coming months.

Mr. HATCH

Mr. HATCH. Mr. President, my heart is heavy. Utah has once again given one of her sons to the cause of liberty. Any loss of our fine young men or women is a tragedy. However, I believe this is particularly so with the loss of SP4 David J. Goldberg. He was a fine young man, loved dearly by his parents and wife. Though of a young age, he had already accepted the responsibilities of a man and had volunteered to serve his Nation during a time of war. This sense of responsibility, especially to his fellow soldiers, was one of the defining characteristics of his life. I have learned from the many who knew him and loved him that the specialist was always there for his fellow soldiers, frequently volunteering for extra assignments when others were not available. He will be greatly missed. And so, another name has been added to Utah's List of Honor: SP4 David J. Goldberg. He joins an illustrious list that includes CPT Nathan S. Dalley, West Point graduate and a member of the Army's 1st Armored Division, SSG James W. Cawley, U.S. Marine Corps Reserve; SSG Nino D. Livaudais of the Army's Ranger Regiment; Randall S. Rehn, of the Army's 3rd Infantry Division; SGT Mason D. Whetstone of the U.S. Army and former Special Forces soldier Brett Thorpe. Their names and the service they performed is something that I shall never forget. I shall always honor them and their families. cpt nathan s. dalley, u.s. army Mr. President, on November 17, God called home one of our best and brightest, CPT Nathan S. Dalley. At the young age of 27, Captain Dalley entered the hallowed list of those sons and daughters of Utah who have given their lives for their country. Captain Dalley epitomized what a soldier should be: a born leader, mindful of his responsibilities, and eager to help and encourage others. He was exceptional in many ways, yet a decent man that treated everyone with respect. You see, I had the honor of knowing Captain Dalley. I was proud to nominate him to the United States Naval Academy; however, he decided to pursue his career in public service with the Army and attended West Point. It should also be noted that he was also accepted to the Air Force Academy; remarkable achievements by any standard. While preparing these remarks, I went through my files and found these words from this young man's Advanced Placement History teacher, who wrote a nomination recommendation: As impressive as [Nathan Dalley's] academic qualities are, I find his personal qualities to be even more impressive . . . His kindness and friendliness to everyone set him apart in the classroom, and in the larger school setting. In my class he was a remarkably effective cooperative learner and peer tutor. Nate understands that his contributions to the community as a whole are as important as his personal academic success, and I have every confidence that he will be successful in his future pursuits. Captain Dalley not only met these high expectations, but exceeded them. To his mother, his sisters and his fiancee, I would like to say that, although I have no words to minimize your grief, I hope there is some comfort in knowing that all who knew your son respected him and knew him to be a good friend. I will never forget Nathan Dalley or the others from Utah's list of honor. Their sacrifice will make a difference, their will be freedom in Iraq, and those who would destroy liberty will be brought to justice. So today we add CPT Nathan S. Dalley to this illustrious list that includes SSG James W. Cawley, United States Marine Corps Reserve; SSG Nino D. Livaudais of the Army's Ranger Regiment; Randall S. Rehn, of the Army's 3rd Infantry Division; SGT Mason D. Whetstone of the United States Army; SP4 David J. Goldberg of the Utah-based 395th Finance Battalion, Army Reserve and former Special Forces soldier Brett Thorpe. We will honor them always and stand fast behind their families.

Mr. HATCH

Mr. HATCH. Mr. President, I rise to make a few comments about the historic Medicare legislation that President Bush signed into law yesterday. I will center my remarks today on the provisions of the bill that amend the Drug Price Competition and Patent Term Restoration Act of 1984. I am a coauthor of the 1984 law and it is of particular interest to me. This law, often referred to as the Waxman-Hatch Act or Hatch Waxman, is of great importance to my fellow Utahns and the rest of the American public as it saves an estimated $8 to $10 billion for consumers each year. Over the past 2 years, the Senate has spent considerable time and effort debating refinements to the 1984 law designed to close some loopholes that emerged and were exploited. While I would have preferred a more comprehensive reexamination of the statute with the goal of assessing how the law might be changed to facilitate new biomedical research and how best to disseminate the fruits of this research to the public in a quick and fair fashion, the amendments made to Hatch-Waxman made under the leadership of Senators Gregg, Schumer, McCain, Kennedy, Collins, and Edwards are very significant. It has been my position for some time that once the Congress adopts and the President signs, as he did yesterday, Medicare reform legislation that includes a prescription drug benefit, pressure will grow on Congress and the Food and Drug Administration to find new ways to bring new biotechnology products to the public when the patents expire. The Center for Medicare and Medicaid Services will be compelled to look for ways to economize on the purchase of drugs and it seems likely to me that the Department of Health and Human Services will have to explore regulatory measures that can produce saving. The Commissioner of Food and Drugs, Dr. Mark McClellan, has indicated a willingness to examine this issue. Few, if any, of my colleagues in Congress have to date joined in the discussion surrounding whether and, if so, how to create a fast track approval system for biologic products, but I believe the bill signed into law yesterday will encourage this debate. I welcome this debate and recognize that very important public health matters are at its heart. As well, retaining America's worldwide leadership in biomedical research is at stake whenever we consider legislation that affects pharmaceutical related intellectual property. We must proceed carefully but we must proceed. Critical to the success of this debate is a need to observe the principle of balance contained in the original 1984 law so that both research based firms and generic firms receive new incentives that will allow them to continue to produce and distribute the products that the American public deserves. As more and more biological products come to the market, the pressures on the Federal Government, State governments, private insurers, and private citizens to pay for these products will result in considerable pressure to create a fast track FDA approval system for off-patent biological products. Such a mechanism was not discussed in the 1984 negotiations that resulted in Hatch-Waxman largely because the biotechnology was still in its infancy. This is not the case today. Few, if any, of my colleagues in Congress have to date joined the discussion surrounding creating a fast track approval for off-patent follow-on biologic products, but I believe the new law signed yesterday will encourage this debate. As part of an appraisal of the laws relating to the development and approval of pharmaceutical products, I would also hope that my colleagues and the public will examine the full complement of incentives that Senator Lieberman and I have included in our bi- partisan bioterrorism bill, S. 666. These incentives, which include day-to-day patent term restoration and a harmonization of the marketing exclusivity period to the 10-year term employed by the EU and Japan, will be helpful for the development of countermeasures to bioterrorist attacks and they should also be carefully considered with respect to developing new vaccines, diagnostics, and preventive and therapeutic agents for a host of other diseases and conditions. With respect to the patent challenge provisions of the Medicare bill, I want especially to commend the efforts of Senator Gregg, Chairman of the HELP Committee and the Majority Leader, Senator Frist, for working so hard to improve this legislation. There can be no doubt that the bill the President signed yesterday is a big improvement compared with the McCain-Schumer bill of last year, S. 812, that passed the Senate. I must also commend my colleagues in the House including, Commerce Committee Chairman Billy Tauzin, Commerce Committee Ranking Democrat John Dingell, and my colleagues from the House Judiciary Committee, Chairman Jim Sensenbrenner and Ranking Democrat John Conyers, and Intellectual Property Subcommittee Chairman Lamar Smith for their help in vastly improving the Gregg-Schumer-Kennedy amendments that passed the Senate by a 94-1 vote this summer. As the sole dissenter in the Senate, I am pleased the conferees were able to work in a bipartisan, bicameral spirit to correct the constitutional flaw in the Senate-passed bill. I commend the Department of Justice for its work that helped dislodge the unconstitutional ``actual controversy'' language from the declaratory judgment provision of the bill. I am also pleased that the conferees decided to reject the provision of the Senate bill that would have resulted in the so-called parking of exclusivity in cases in which a generic challenger could show that the patents held by a pioneer drug firm were not infringed or were invalid. In order to give an incentive for vigorous patent challenges, the 1984 law granted a 180-day head start over other generic drug firms when the pioneer firm's patents failed or were simply not infringed. As I will explain in some detail, I think there may be a way to improve this language further and to save consumers a considerable sum of money in the process. The 180-day marketing exclusivity rules were first enacted as part of the Waxman-Hatch Act. The policy behind these provisions is to benefit the public by creating an atmosphere that ensure vigorous challenges of the patents held by innovator drug firms. The intent of this section of the 1984 law was to award the 180-day head start to the first successful challenger of a pioneer firm's patents. Unfortunately, we drafters of the statute employed language that has been interpreted by the courts to grant the 180-days of exclusivity to the first generic drug applicant to file an application with the FDA that challenges the patents. I must say that in most cases the first filer and first successful applicant was the same applicant. But I believe that the line of court decisions that include the Mova and Granutec cases has resulted in the establishment of a first filer regime that is not without unintended consequences and perverse incentives. The mismatch between the rights accorded to the first applicants and first successful challenger contributed to an atmosphere in which anticompetitive agreements were entered into between certain pioneer and generic drug firms. I am pleased that the Medicare reform bill signed into law yesterday contained Senator Leahy's Drug Competition Act, which is designed to increase enforcement of longstanding provisions of antitrust law that prevent anti-consumer agreements. The 2002 FTC study, ``Generic Drug Entry Prior to Patent Expiration,'' catalogs the agency's actions in this arena including such cases as those involving Hoescht and Andryx and Abbott and Geneva. I am also pleased that the Senate language prevailed on Senator Leahy's Drug Competition Act so that potentially anticompetitive agreements between research-based and generic drug firms will be reported to both the Department of Justice and the Federal Trade Commission. I worked extensively with Senator Leahy on his bill in the 107th Congress and took the lead, with his cosponsor, Senator Grassley, in convincing the House conferees of the wisdom of the Senate's dual reporting requirement. So, the conferees made a number of important improvements to provisions of the legislation affecting challenges to drug patents. At our August 1, 2003, Judiciary Committee hearing, both the FDA and FTC expressed reservations about some elements of the Senate bill's rules pertaining to the 180-day marketing provision. The Administration, correctly in my view, took exception to the provisions in the Senate bill that would have allowed a sue now/use the exclusivity later--and perhaps years later at that--policy on marketing exclusivity. At the August 1st hearing, Mr. Robert Armitage, General Counsel of the Eli Lilly Company, presented compelling testimony on the matter of ``parking'' or delaying, the use of the 180-day exclusivity until the basic patents expire. The question confronting policymakers centered on the wisdom of retaining the Gregg-Schumer-Kennedy provision that would have encouraged very early lawsuits by those with, for examples, noninfringing formulations of the pioneer product, in order to gain the potentially very lucrative 180-days of exclusivity down the road. I welcome and expect that day will come when Congress will reexamine the whole rationale and operation of the 180-day marketing exclusivity provisions. The day will come when the Congress will be forced to confront the incongruity in the statute, pointed out by my friend and skilled patent-challenging lawyer and philanthropist, Al Engelberg, is awarding 180 days both for a successful invalidity challenge and an non-infringement action. The former, a finding of invalidity, accrues to all generic firms while the latter benefits only the specific non- infringer. This is a distinction with a difference in a sector of the economy where a whole cottage industry has grown up fueled in large part by non-infringement suits to non-basic patents. It is less than clear that the public benefits as much as it can or should under the present system which is left largely in place by the new bill language. This issues deserves further discussion. Nevertheless, I am pleased that the Senate language that allowed long-term parking of exclusivity was modified in an important way by the conferees. I want to commend the FDA and especially the Chief Counsel for Food and Drugs, Mr. Dan Troy, and the soon-to-be betrothed Associate Commissioner for Legislative Affairs, Mr. Amit Sachdev, for their contributions in this area. Having now commended the administration for helping to improve materially the Senate version of the 180-day provisions, I must also unfortunately report to my colleagues in the Senate and to the American public that we have not accomplished as much as possible with respect to the 180-day provisions. First off, I continue to believe that it is both unfair and ill- advised to retain the bill language that does not reward a non-first- filer to gain the 180-days marketing exclusivity in the case, which will admittedly be rare, in which the subsequent filer prevails on a patent invalidity challenge. I am told that conferee staff first thought that the provision as drafted, and now signed into law, would result in a subsequent filer's successful invalidity challenge forfeiting the first filer's 180 days of marketing exclusivity. Although the successful challenger does not get the 180-day head start, at least under this reading, the subsequent successful challenger is not penalized with respect to market entry. Upon further scrutiny of the statutory language, it is my understanding that in such circumstances the language may actually work to grant the 180-days of marketing exclusivity to the first filer, so that the successful subsequent challenger not only does not get the 180-day benefit, but actually receives a 180-day penalty for invalidating the patent. If this is the correct way to read the statute, the law should be changed. I am told that the staff of any conferee nor the FDA strongly defended this policy. Unfortunately, nor was there agreement to change the language to at least clarify that the subsequent challenger's success was at least a forfeiture event or, preferable from my perspective, would result in the granting of the 180-days to the successful challenger in a patent invalidity challenge rather than benefitting the fastest paper shuffler. This is bad policy. Finally, I must unfortunately report to my colleagues that the new statute retains the Gregg-Schumer-Kennedy provision that may cost the Federal government, according to the Congressional Budget Office, $700 million over the next 10 years. Moreover, it is my understanding that the total cost of this provision to consumers over the next 10 years could exceed $3 billion. At issue are the sections of the bill that essentially give the first filer an exclusive right to the potential 180-day marketing exclusivity until its case is decided at the appellate court level. The question arises of what happens if a subsequent filer is not sued by the pioneer firm and is ready, willing and able to go to market but for waiting for the disposition of the first filer's challenge in the appellate court? If the first filer prevails in the appellate court, it will receive the 180-days of exclusive marketing even though one or more subsequent filers were ready, willing, and able to go to the market long before the first filer's challenge was resolved. I would also note the FTC study documents that when the first filer wins in the district court, they almost always prevail on appeal. The FTC opposed reinstating the earlier policy of the appellate court trigger because it believes that, on average, consumers will lose out while generic firms get an extra measure of certainty. In any event, subsequent to the Judiciary Committee hearing in August and throughout the fall as the conference committee met, I was involved in participating and facilitating discussions designed to craft language to close this new loophole sanctioned by the Gregg-Schumer- Kennedy language as well as to make a few other clarifications to the parking language. Specifically, I preferred statutory language that would automatically convert unsuccessful Paragraph IV invalidity/ noninfringement challenges to standard Paragraph III--``the patents expire on''--applications. FDA believes it can accomplish this by rule or guideline, but the courts have not been kind to FDA rulemaking with respect to Hatch-Waxman in recent years. While I am mindful that the forces behind the first filer system of challenge have won the day in this legislation, I think in the circumstance when the subsequent challenger has not been sued, and may have even been issued a covenant not to be sued by the pioneer firm, that the first filer should at least forfeit its 180 days if it is not prepared to go to market in the 75-day grace period the new provision creates. This is good for the consumer and sound policy since the rationale behind the 180-day provision is to create an incentive for challenges to the pioneer's patents, not to create an entitlement to the first applicant to file a patent challenge with the FDA in the Parklawn Building. It seems to me that the first time that a blockbuster product is kept off the market, perhaps for over a year, due to the application of this new law and there is a second generic ready, able and willing to go to market, there will be a great public clamor, as there should be. At one point, I thought I was close to agreeing to language with Senator Kennedy and others to close this new loophole. Unfortunately, we did not reach agreement and since this was a part of the legislation in which the Senate and House language was virtually identical, it is understandable the conferees concentrated their efforts on those many provisions in which there were substantial differences. On the very last days before the conference report was completed, Senator Schumer and I also came close to closing this newly created loophole, but time ran out on this effort. Let me just say I am mindful that the politics and financial interests with respect to this issue among those in both the research- based firms and generic drug companies are a very sensitive matter. I also recognize it will be exceedingly difficult to reopen these provisions now that the President has signed the bill into law. Nevertheless, I think we got this aspect wrong and we should try to fix it. I pledge to continue to work with Senator Gregg, McCain, Schumer, Kennedy as well as Representatives Tauzin, Dingell, Sensenbrenner, Smith, and Conyers and other interested members of Congress and other affected parties to fix this problem before consumers have to pay for this ill-advised policy. In the interest of moving this issue along in a constructive fashion, I have developed a discussion draft that emerged out of my discussions with Senator Kennedy and others that addresses these issues. Frankly, much of this draft reflects refinements to a draft that Senator Kennedy prepared in part as a response to a draft prepared largely by several private sector parties earlier this year that I submitted to the Medicare conferees for their consideration. It is my understanding that the administration does not oppose this language but, unfortunately, neither did it support this approach due, in some measure, to the fact that it was not anxious to open new issues in the already complex Medicare conference. Although they both opposed the underlying Medicare reform bill, I commend my colleagues, Senators Kennedy and Schumer for their interest in improving this particular aspect of the legislation. In closing, let me say again that Senators Gregg, Kennedy, Schumer, McCain, and Frist have worked hard to improve the patent challenge provisions of current law and all deserve our thanks. I am very proud of the Drug Price Competition and Patent Term Restoration Act, which has done so much to help consumers have access to more affordable medications. The underpinning of this great consumer measure is a very complex, legal framework. Any changes to the law must be carefully scrutinized to assure they achieve their intended effect. I plan to monitor very carefully the implementation of the first, substantial Waxman-Hatch amendments in almost two decades and intend to work with my colleagues to make certain they achieve their intended purpose. I welcome the views of any interested parties who wish to comment on this discussion draft, as well as other implementation issues that the Congress should consider. At the same time, I think there are broader issues here it behooves the Congress to consider. These include the issue of follow-on biologics as well as whether the law today contains the appropriate incentives, including intellectual property incentives, for pharmaceutical research and development in light of the fact that science appears to be moving away from an era of large patient population, small-molecule medicine to small patient-population, large biological molecule therapies. Mr. President, I ask unanimous consent that the draft be printed in the Record.

Mr. HATCH

Mr. HATCH. Mr. President, I stand today in strong support of D. Michael Fisher, who has been nominated to serve for the U.S. Court of Appeals for the Third Circuit. Let me speak briefly about his background and the reasons I endorse his confirmation. Attorney General Fisher has extensive legislative experience, having served for 22 years in the Pennsylvania General Assembly. He has also practiced in civil litigation for close to 20 years. Parenthetically, I would note my understanding that Attorney General Fisher's first law office was across the hall from my law office in Pittsburgh--the 9th floor of the Frick Building--in 1970. Since 1997, Attorney General Fisher has served as Pennsylvania Attorney General and he has been a great leader. He coauthored Pennsylvania's Megan's Law; he supported the passage of a State DNA postconviction statute; and he helped negotiate the landmark national tobacco settlement. Attorney General Fisher's nomination is widely supported. His endorsers include Democratic Pennsylvania Governor Edward Rendell, the bipartisan 19-member Pennsylvania delegation to the U.S. House of Representatives, Pennsylvania State legislators, the Pennsylvania District Attorneys Association, and the Pennsylvania Trial Lawyers Association. He is also fully endorsed by serving attorneys general from across the country. The former attorney general of Tennessee, Charles W. Burson, who also served as legal counsel for former Vice President Gore, has written in support of Attorney General Fisher's nomination: ``While [Attorney General Fisher] and I may differ on particular issues, I am certain that as a Federal Appellate Judge, he will deliberately, and with an even hand, apply the law to the facts and render sound judgments.'' I cannot recall seeing such a range of support for a judicial nominee as Attorney General Fisher enjoys. It is truly impressive and speaks well of him. I will support Attorney General Fisher's confirmation, and I urge my colleagues to do the same.

Mr. HATCH

Mr. HATCH. Mr. President, I am pleased that the Senate today confirmed James B. Comey as the Deputy Attorney General. James Comey brings a wealth of experience and perspective as a line prosecutor, as a manager in the U.S. Attorney's Office for the Eastern District of Virginia, and most recently as the U.S. attorney for the Southern District of New York. His record demonstrates that he is a leader, one who can inspire others to accomplish great things, and one who can oversee and manage an organization such as the Justice Department. With the recent departure of Larry Thompson, who was a fine Deputy Attorney General, I am sure everyone shares my view that Mr. Comey has very big shoes to fill. However, I am confident that he is the right person for the job. His impressive background and past government service make me confident that he will be a great asset to the Department of Justice, the Judiciary Committee, and the American people. The importance of the Deputy Attorney General within the Justice Department cannot be overstated. Over the years, the Deputy Attorney General's Office has played a greater role in overseeing the Department's operations, implementing new policy initiatives, and ensuring the effective enforcement of our criminal and civil laws. A review of Mr. Comey's record establishes one simple fact--he is well qualified to serve as the Deputy Attorney General. Since January 2002, Mr. Comey has served as the U.S. attorney in the Southern District of New York, an office that many consider to be the premier U.S. Attorney's Office in the country. In the Southern District of New York, Mr. Comey has earned the respect of judges, defense counsel, and prosecutors for his professionalism, fairness and judgment. While serving as the U.S. attorney, Mr. Comey was responsible for leading his office in some of the more significant terrorism and white collar prosecutions. Prior to assuming the position as the U.S. attorney, Mr. Comey served from 1996 to 2001, as managing assistant U.S. attorney, in charge of the Richmond Division of the U.S. Attorney's Office for the Eastern District of Virginia. From 1993 to 1996, Mr. Comey was an associate and later a partner at the law firm of McGuire Woods in Richmond, VA. Early in his career, from 1987 to 1993, Mr. Comey served as an assistant U.S. attorney in the Southern District of New York. As a Federal prosecutor, Mr. Comey investigated and prosecuted a wide variety of cases, including firearms, narcotics, major frauds, violent crime, public corruption, terrorism, and organized crime. In the Eastern District of Virginia, he handled the Khobar Towers terrorist bombing case, arising out of the June 1996 attack of a U.S. military facility in Saudi Arabia in which 19 airmen were killed. Mr. Comey was educated at William & Mary, B.S. with honors 1982, chemistry and religion majors, and the University of Chicago Law School, J.D. 1985. After law school, he clerked for then-U.S. District Judge John Walker in Manhattan. Let me take one moment to highlight perhaps Mr. Comey's most important accomplishment. While serving his country in a variety of prosecutorial positions, he has demonstrated that he is a dedicated family man. He and his lovely wife, Patrice, are raising five wonderful children, ranging in age from 15 to as young as 3 years old. Mr. Comey is a dedicated public servant, and a talented and well- respected prosecutor. He is uniquely qualified to lead as the Deputy Attorney General of the Justice Department.

Mr. HATCH

Mr. HATCH. I have been listening to the rather remarkable remarks from the other side, that this legislation has been rammed through the Congress, that it is partisan, when it is bipartisan. It has taken us 15 years to get here. It could take another 15 years if we do not support this bill right now. We have been working on Medicare prescription drug legislation for 15 solid years. We have worked day in day out, hours, weeks, and months in order to get to this point. It is bipartisan. It was bipartisan in the House; when it passes today it will be bipartisan in the Senate. The opponents of this bill keep saying that seniors will be worse off if this Medicare bill becomes law. Give me a break. We are going to put $400 billion out there for senior citizens so they will have a Medicare drug benefit. We are giving seniors a choice in coverage. Medicare beneficiaries may stay in traditional Medicare or they may choose to participate in one of the new Medicare Advantage plans. We are improving health care for rural communities, something our friends on the other side have ignored for years. The fact is, it is time to realize that we are going to have to pass this legislation because it is the right thing to do and it will be a bipartisan vote. We are devoting close to a quarter of this bill's funding to retiree health coverage. CBO told us that 37 percent of retirees could have lost their coverage if S. 1, the bill approved by the Senate earlier this year, had become law. This bill reduces that number to under 20 percent. I don't know how anyone can say this bill is going to be harmful to retirees when we are devoting $89 billion towards retaining retiree health coverage. We also are improving access to less expensive, generic drugs by improving Hatch-Waxman. The real reason our colleagues do not like this bill is that it is not an $800 billion bill. Our bill is $400 billion which provides for some private sector competitive models. The reason our opponents do not like our legislation is because they do not believe in the private sector. With regard to their argument that some of the big companies are going to benefit from this legislation, of course they will benefit. The argument I find most amusing is the claim this bill will lead to increased drug company profits. The reason the bill is so desperately needed is because beneficiaries with low incomes are unable to afford their prescriptions today. They have to choose between food, rent, and taking their medicines. When this prescription drug benefit goes into effect, low-income beneficiaries will finally be able to get their prescriptions filled. This legislation includes generous subsidies so the low-income will be able to receive their prescription drugs without worrying about how to pay for them. Of course, this is going to lead to increased drug sales. Surely this is no surprise to anyone. Any prescription drug bill that works is going to lead to increased drug sales. Where are the medicines supposed to come from, except from the manufacturers of those medicines? Every single Medicare prescription drug bill introduced by these naysayers also would have increased drug sales, and they know it. This bipartisan conference report has the same basic drug benefit structure that passed the Senate by a vote of 76 to 21--the same one-- and we are hearing these arguments here today? My distinguished friend from Massachusetts voted for that bill, and the legislation before us has the same drug benefit structure contained in S. 1 earlier this year. The Congressional Budget Office has concluded that the competitive approach of this bipartisan drug benefit will be better at controlling drug costs than other proposals. To suggest that no one support a Medicare drug benefit because it will lead to increased drug sales turns logic on its head. If this were our basic principle, then we should not have food stamps, because that would lead to increased profits of grocery stores and farmers. What about housing subsidies? This might lead to profits by construction companies, utility companies and increased sales of lumber, bricks and nails! So, this is just an absurd issue and it is easy to see why. I am here to tell you that this bill will strengthen and improve the Medicare program. The spending in this bipartisan prescription drug bill goes toward more improved health benefits for America's seniors and the disabled. This is a good bill and I urge my colleagues to support it.

Mr. HATCH

Mr. HATCH. Mr. President, I give tribute to my dear friend C. Booth Wallentine, who, just days ago, began a very well earned retirement after serving for 41 years in the Farm Bureau. Thirty-one of those years he served as the executive director of the Utah Farm Bureau. Booth is an institution in my State, and I have to say that when agriculture issues come up, my first question often is, ``What's Booth's take on this?'' Even on rare occasions when we have disagreed on an issue, I found it valuable to understand his perspective. As far as I am concerned, nobody knows agriculture in Utah like Booth Wallentine, and I dare say that no state Farm Bureau director knows Congress and the legislative process like Booth Wallentine, either. This combination of expertise in the substance and in the process of agriculture policy-making has helped to set Booth apart as a highly effective advocate on behalf of Utah agriculture interests. It has also helped him to provide service in various other ways. He served as vice chairman of the Salt Lake Chamber of Commerce as well as chairman of the board of Utah State University. Remarkably, both institutions awarded him their respective distinguished service awards. He also served as the president of the Utah Council on Economic Education and chaired the Utah Farm Service Agency Committee on Risk Management. Somehow he found the time to help establish the National Mormon Pioneer Trail Foundation and was asked to chair the Department of the Interior's Historic Trail Commission. But wait a minute, there's more. Booth Wallentine was Utah State University's very first inductee in their Agriculture Hall of Fame, he was named the Future Farmers of America Farm Leader of the Year, a Friend of the Cattlemen, a Friend of Utah Wool Growers, and he earned the Utah State Extension Leadership Award. Booth was also officially recognized by the Environmental Protection Agency for his environmental leadership in helping farmers to improve Utah's water quality. I should point out that this is not a complete list, but it serves to make the point that Booth Wallentine is a great American. He has helped Utah in so many ways. I know that I will miss him dearly, but I gain some comfort knowing that while he goes into retirement, we continue to benefit from the wisdom he shared with us and the legacy he has left. I thank my friend, Booth Wallentine for serving so long and so well. I pray that the Lord will bless him and his sweet wife, Raeda, in their retirement.

Mr. HATCH

Mr. HATCH. It is my understanding I have 7 minutes.

Mr. HATCH. Mr. President, I have listened carefully to the debate on H.R. 1 during the last few days. I regret to say I have heard many half-truths and misrepresentations about our bill from the opponents of the legislation. This simply won't stand. We're reaching the point where twisted facts and wrong-headed reasoning have been repeated so often that even those who know better are no longer jarred to hear it. As one of the conference committee members who actually wrote this bill, I find this untenable, because the opposition is just scaring and confusing Medicare beneficiaries. The last thing any of us want is for critical decisions to be made in a climate of fear or in a fog of uncertainty. Yes, this legislation is not perfect. But it is good. I'll tell you why. First, and most important, this bill provides all beneficiaries-- seniors and the disabled--with voluntary prescription drug coverage for the first time in almost 40 years. Coverage for their medications is something Utah beneficiaries have sought for decades. Not a day goes by that I do not receive a letter from some part of Utah beseeching Congress to pass this bill. Second, that coverage will be immediate. Seniors wherever they may live, from St. George to Logan, from Tooele to Vernal and down to Blanding and Monticello, will be able to use a new drug card to get an immediate discount on their medications. Third, the program is voluntary. We all know--as do the bill's opponents--that beneficiaries will not be forced to join this new drug program. If they are happy with the status quo, then things can stay as they are. If they want to participate in the new program--it will be there for them. Fourth, H.R. 1 provides choice in coverage. Beneficiaries may stay in traditional Medicare and elect to take a stand-alone drug plan if they want one. Or they may receive their coverage through a local health plan or the new regional PPO plans offered through the new Medicare Advantage program. How often does a Federal program offer people the range of choices that this bill creates? Fifth, this bill preserves retiree health coverage. Close to one- quarter of the spending in this bill, approximately $89 billion, is dedicated to protecting retiree health benefits. For the first time--and none too soon--Medicare will provide funding as an incentive for employers to continue retiree health coverage. Under this bill, no beneficiary will be forced to drop retiree health coverage and participate in the new prescription drug program. Sixth, the conference agreement is good for rural America, which has gotten the short shrift under Medicare for some time. We want to ensure that Medicare beneficiaries will have access to quality health care, no matter where they live. We also want rural providers, providers in Moab and Panguitch, providers in Price and Manti, providers who dispense vital health services to beneficiaries, to be properly reimbursed for their services. This legislation accomplishes those important goals. Seventh--as I intend to amplify later--this legislation improves the Drug Price Competition and Patent Term Restoration Act of 1984, better known as Hatch-Waxman. The conference agreement strengthens the 1984 law so it is easier for everyone, including seniors and the disabled, to have timely access to less expensive, generic drugs. Eighth, the Medicare agreement includes an appropriate response to the question of reimporting prescription drugs into the United States. While we include the provisions contained in the legislation approved by the Senate, this agreement also requires the HHS Secretary to conduct an extensive study that identifies the barriers to implementing a drug reimportation program. Many of my constituents have written, asking why they cannot use the lower cost medications from Canada. The answer is easy: it is just irresponsible for Congress to jeopardize public safety by allowing the unchecked reimportation of drugs. That is why I adamantly opposed the House policy. If we truly care about our seniors and other patients who depend upon prescription drugs, we should not expose them to what amounts to pharmaceutical Russian roulette. And, finally, we have done all we can to craft a bill that is as cost-conscious as possible, a bill that the Congressional Budget Office has certified stays within our budget, and a bill that minimizes bureaucracy whenever possible. We have worked hard to write a measure that relies whenever possible on the private sector, not on exploding the size of big, Washington government. Before I conclude, I would like to take a minute to refute some of the points that have been raised by the opponents of this legislation. Yesterday, I heard my good friend from Massachusetts talking about how he feels that the Senate is being stampeded with a bad bill. It is hard to argue we are being stampeded, when we have worked on this issue for almost 15 years. I also have heard our colleague say this legislation dismantles the Medicare program and that the HMOs are going to make out like bandits. Again, that is simply not true. Guess who was one of the people who helped to bring about HMOs. None other than the senior Senator from Massachusetts. This agreement improves the Medicare program by giving beneficiaries voluntary prescription drug coverage for the first time in 40 years-- that is a reaffirmation of Medicare, not a weakening of it. We also give beneficiaries expanded choices in their health care coverage; they may remain in traditional Medicare or in their retiree health care plan. Or they may receive their coverage through local or regional plans offered to them through the new Medicare Advantage program. Contrary to what my friend from Massachusetts says, no one will be forced into an HMO, and I hope that the American people are not buying that kind of scare tactic. The other fallacy that I heard during this debate was that the premium support demonstration project, which would be conducted in only six metropolitan areas, is going to disadvantage beneficiaries who remain in traditional Medicare. I have heard it said that those premiums could go up by 10, 15 or 20 percent, even though we who wrote the bill know that the Part B premiums for traditional Medicare could not rise by any more than 5 percent over the regular premium. This rhetoric is absolutely outrageous. If you look on page 254 of the conference report, you will see that it is not true. The legislative language speaks for itself: ``The amount of the adjustment under this subsection for months in a year shall not exceed 5 percent of the amount of the monthly premium.'' In addition, if a beneficiary is under 150% of poverty, there is no impact on premiums at all. And I am really getting tired of Speaker Newt Gingrich's words being continuously misconstrued. He never said, as my colleagues on the other side of the aisle like to assert, that he wanted Medicare to wither on the vine. What he did say is that the agency that controlled Medicare, HCFA, should wither on the vine because it was filled with bureaucrats that were strangling the program. That is a far cry from what they have been representing-- person after person after person. He was arguing against large bureaucracies and for seniors to have more control over their health care. I have saved the best for last: the accusations and allegations made against the AARP, which are truly amazing to me. It is truly amazing how last year they were considered to be the greatest organization on Earth by folks on the other side of the aisle, but this year they are dirtier than dirt. That is just not true. It is ironic that some in this Chamber are criticizing the AARP for supporting a bill that will provide drug coverage to Medicare beneficiaries. What a difference a year makes! Last year, the AARP could do nothing wrong in the eyes of today's opponents. Yet, suddenly the AARP is either greedy or being taken in like a bunch of half-wits. So much for honest disagreement among friends! What has changed? What does AARP know that the opponents of S. 1 do not? AARP knows that this may very well be our last chance to enact a program adding prescription drug coverage to Medicare. AARP knows, as we all do, that this is not a perfect bill. But AARP also knows that this bill lays a solid foundation which we can refine in the future. In the eyes of this Senator, AARP has made a courageous decision by endorsing our proposal and I greatly appreciate their support In conclusion, I want to commend the chairman of the Senate Finance Committee, Chuck Grassley and the ranking minority member, Max Baucus on a job well done. I also want to compliment the Majority Leader, Dr. Bill Frist, on his leadership in shepherding this bill through the Senate. Today we will make history. We will break gridlock. We will act decisively to help the people of this great country. The citizens of this great country are counting on us to get the job done. So, let us clear away all the parliamentary hurdles and pass H.R. 1. It is the right thing to do. One last thing. I have heard some of my colleagues who are opposed to this bill raise the issue that Government can do nothing to help restrain the growth of drug costs or bring drug costs down. Again, this is a misrepresentation of what the conference agreement actually does. The conference bill specifies the Government ``may not interfere with the negotiations between drug manufacturers and pharmacies and PPO sponsors and may not require a particular formulary or institute a price structure.'' Opponents claim that provision, which originated with Democratic proposals, by the way, is a concession to the pharmaceutical industry. That is why it is so phony to hear these arguments. They are plain wrong. The noninterference provision is at the heart of the bill's structure for delivering prescription drug coverage. It is a good deal for consumers rather than price fixing by the CMS bureaucracy, which I believe is opening the door for universal health care. It is a misrepresentation of the language in this provision to argue otherwise.

Mr. HATCH. Mr. President, I have listened to my dear friend and colleague from Massachusetts. I guess he wants us to spend another 15 years either trying to reform Medicare, improve Medicare or pass another prescription drug benefit program through the Congress. We are putting up $400 billion over 10 years, for both a Medicare drug benefit, something that seniors currently do not have today, and Medicare program improvements. Medicare beneficiaries have a choice of whether or not they want to participate in this program. They may remain in traditional Medicare. And, to be honest with you, those remaining in traditional Medicare who end up participating in the comparative cost adjustment demonstration project will not see their premiums increase more than 5 percent.

Mr. HATCH. I only have a few minutes, so I would like to finish my comments. According to my colleague from Massachusetts, we are dismantling Medicare. That could not be further from the truth. How can we say that--when we are improving and strengthening Medicare, we are giving Medicare beneficiaries a choice of coverage, and we are giving them $400 billion to help with their prescription drug coverage and Medicare benefits. These new choices include the plans created under the new Medicare Advantage Program, the stand-alone drug plan, the regional plans, the local plans--how on Earth is that dismantling Medicare? And this coming from one in this body who was one of the major proponents of HMOs, to begin with? I might add, I have been here long enough to have remembered that. Next is Social Security? Nobody in this body wants to hurt Social Security, and the Senator from Massachusetts knows that. Since when does the Washington Post have the inside track on the Senate Republican agenda? Give me a break.

Mr. HATCH. I am going to finish in just a minute. Again, I think my friend from Massachusetts, as great a Senator as he is, is trying to scare senior citizens. And, frankly, I think to say let's just not pass this bill and let's go back to the drawing boards is just plain wrong. The Members of the Medicare conference have been meeting for hours and hours, days, weeks, months to figure out how to provide Medicare beneficiaries with the best drug coverage possible. There are Members of Congress who have been working on this issue, trying to get a bill signed into law, for close to 15 years. And we are almost at the finish line. Yet my good colleague wants to go back to another 15 years of floundering around on this issue. Now, if beneficiaries did not have choice in drug coverage, maybe my friend from Massachusetts would have a point. But seniors will have choice in coverage. Why would we go back to the drawing board, especially after all the time and effort we have put in this legislation? We have before us a bill that really does so much for seniors. The AARP is coming out strongly behind this bill, because they know full well that it is the last train out of the station, it is the only way we can go. I urge my colleagues to support this legislation so Medicare beneficiaries can finally have what they have wanted for close to 40 years--comprehensive prescription drug coverage.

Mr. HATCH. I yield the floor.