Joe Barton

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Chairman, will the gentleman yield?

Mr. BARTON of Texas. Yes, Mr. Chairman. I would revise my unanimous- consent request and ask unanimous consent that the gentleman from Michigan [Mr. Dingell] control 7\1/2\ minutes and yield as he sees fit; that I control 7\1/2\ minutes in support of the amendment and yield as I see fit; and that the gentleman from Florida [Mr. Canady] control the 15 minutes in opposition.

Mr. BARTON of Texas. Mr. Chairman, if the gentleman would yield, I am more than willing to yield all the time in opposition for the gentleman to control. I thought perhaps there might be a member of the minority that also wanted to control some of that time, but if obviously there is not, it is his time.

Mr. BARTON of Texas. Mr. Chairman, I ask unanimous consent that the gentleman from Michigan [Mr. Dingell] and myself, who are proponents of the amendment, each control 7\1/2\ minutes, and the gentleman from Florida [Mr. Canady] and a Member of the minority party in opposition, control their 15 minutes and be permitted to yield blocks of time.

Mr. BARTON of Texas. Mr. Chairman, I yield 1 minute to the gentleman from Oregon [Mr. Blumenauer].

Mr. BARTON of Texas. Mr. Chairman, I yield 2 minutes to the distinguished gentleman from Illinois [Mr. Poshard].

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, in this last election cycle, many of us campaigned on the need for the Federal Government to use a common sense approach in dealing with private industry. The regulatory yoke placed upon the medical device industry in the United States by the Food and Drug Administration is a prime example of how a bureaucratic agency can destroy small business, as well as the entrepreneurial spirit. My goal, which I believe is shared with many of my colleagues on both sides of the aisle, is to modernize the Food and Drug Administration. This is to be distinguished from terminating or eliminating the FDA, which I have also been accused of, and I want to make it clear that I believe there is a legitimate need for the FDA. However, it is imperative that this Congress lead the charge to bring the FDA into the 21st century. The current FDA approval process is slow and unpredictable, while at the same time costing the United States jobs, technology, and most importantly--lives. We held numerous hearings in the 104th Congress in my subcommittee and others detailing the need to change the manner in which our domestic device industry is regulated. In the 104th Congress I introduced H.R. 3201 to reform the medical device industry. With the help of many of my Democrat colleagues, especially Bill Richardson and Anna Eshoo, we were able to get 162 cosponsors on H.R. 3201, both Republican and Democrat. This strongly indicates that there is support for FDA reform. I intend to continue refining H.R. 3201 in hopes of obtaining more support. Under the leadership of Jim Greenwood, and with the great deal of help from Richard Burr and Scott Klug, our FDA reform team was able to make amazing strides and I fully intend to maintain this momentum. I will be introducing the Medical Device Modernization Act of 1997 shortly, which will insure the safety and effectiveness of medical devices, assure a predictable approval process for our companies and insure that U.S. patients are receiving the best available medical technology in the world. I will be asking for your cosponsorship and support of this bill. Again it is imperative that we pass reform for the medical device industry. Small business is the nerve center of this county's current economic growth. Sixty-five percent of the companies in the medical device industry have less than 20 employees and 98 percent of medical device firms have less than 500 employees. These are the companies involved in high technology which is fueling economic expansion, these are the companies hiring your constituents, these are the companies doing the research and development that can lead to saving your constituent's lives. These small companies have been more vocal on FDA modernization in the last 2 years and I applaud them in their efforts. We spent a great deal of time laying the groundwork for reform in the 104th Congress for FDA reform by educating Members, conducting oversight hearings, and working with various segments of the industry. It is now time for the 105th Congress to implement the solution. I look forward to working with House Commerce Committee Chairman Bliley, subcommittee Chairman Bilirakis, Congressman Dingell, and Senate Majority Leader Lott in arriving at an acceptable solution to all.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, I would like to thank Chairman Solomon for allowing me the time to express my support for the provision in the 105th Congress House Rules Package which requires that the Speaker of the House, in consultation with the minority leader, develop a system for drug testing the Members, staff and officers of the House of Representatives. I appreciate Chairman Solomon's commitment to ensuring that this provision is a part of the package. In the past several Congresses, I have introduced a bill that would require Members of Congress to be mandatorily drug tested. Since 1989, I have followed this practice myself, by paying out of my own pocket to have both my staff and myself randomly drug tested. However, I have continued to work hard to see that mandatory drug testing be implemented in the entire House of Representatives. I believe that Members of Congress should be mandatorily drug tested, just as our constituents working in federal agencies and private industry are tested. We should not hold ourselves to a different standard than those we represent. As Members of Congress, we have an obligation to not only set policy, but to set an example for those we represent, and show them that we are held accountable for our actions, just as they are asked to be accountable in their jobs. Furthermore, considering the recent rise of drug use among teens in this country, we must send a message to young people that drug abuse is dangerous and wrong, by taking action to institute mandatory drug testing for Members of Congress. I am greatly encouraged by this language in the House Rules Package for the 105th Congress. With this provision, we have the opportunity to institute a tough policy on drug testing for Members and staff in the House of Representatives. I urge my colleagues to support this House Rules Package, which I know the chairman himself and the staff of the House Rules Committee has put a lot of work into. I appreciate Chairman Solomon's willingness to work with me personally on an issue I feel strongly about, especially for the language specifying that the system of drug testing may provide for testing of any Member, officer, or employee of the House. I would especially like to recommend that the drug testing system developed for the House contain a provision that Members of the House of Representatives, in particular, be required to submit to mandatory, random drug tests. Although the traditional method of drug testing is urinalysis, I would like to see the final regulations leave the options open so that Members may have the choice of other methods of testing in addition to urinalysis. Again, I thank the chairman for the time and commend him for his long-standing championship of drug testing so that we may fight the war against drugs and make the Congress more accountable to those we represent.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, I am sure at one time Texas was part of Florida; today, though, we are an independent State of the great 50-State Union. Mr. Speaker, I do rise in support of H.R. 1791 as the chief sponsor in the Committee on Commerce. This legislation is required, quite frankly, because of an oversight in 1990 that both the gentleman from New York [Mr. Manton] and the gentleman from Florida [Mr. Bilirakis] have already referred to. Because of a series of missteps and oversight in subsequent Congresses in 1990, we have never been able to rectify that original mistake until this point in time. There is no opposition to this legislation. The American Medical Association supports it, the Clinton administration, the Health Care Finance Administration that implements Medicaid and oversees Medicaid supports it, the Rural Health Care Caucus supports it. It was reported by committee unanimously on a voice vote. The gentleman from Virginia, Chairman Bliley, has been very active, as has Chairman Bilirakis in subcommittee. The ranking member, the gentleman from Michigan, Mr. Dingell, and the gentleman from California, Mr. Waxman, have been very supportive. So there is no opposition. This rectifies a mistake. Osteopathic physicians are board certified. There are 40,000 of them in the Nation. I have the fortune of having a cousin, Dr. Neil Gibson, who is an osteopathic physician licensed under the State of Texas, educated at the North Texas Health Science Center, Fort Worth, TX, in Mr. Pete Geren's district. He is a physician in west Texas, in a community where he is the only physician that is licensed to practice medicine. Osteopathic physicians conduct over 100 million patient consultations per year. This legislation will make it possible for them to be reimbursed when they are caring for a pregnant woman or a child under the age of 21. This legislation is long overdue. I am sure and hope that it will pass unanimously in the House, and then we will pass it in the Senate, so that it rectifies past mistakes. I am pleased to be the chief sponsor. I want to thank again all the Members of the House on both sides of the aisle that have worked so hard in this Congress to correct a mistake, especially Chairman Bilirakis who has been very, very supportive. I urge unanimous adoption of the legislation.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, if the gentleman will yield, if he will change his position and agree to the bill, I am sure the chairman would give him the right to close.

Mr. BARTON of Texas. Very briefly, I want to reinforce what the gentleman said, Mr. Speaker. This $3 million one-time grant will help start the permanently endowed scholarship fund. Texas A&M is going to raise privately $25 million to permanently endow this scholarship fund. But this $3 million will be the first of the funds for the first class of fellows that are going to begin next year. Of the $3 million, less than $100,000 will be used over the life of the program for administrative expenses. Over $2.9 million will go to fund as many as 200 scholarships. So this is truly, as the gentleman from Pennsylvania [Mr. Clinger] said, a living memorial to a former President.

Mr. BARTON of Texas. Mr. Speaker, I want to reinforce all that has been said in favor of this legislation. Will Rogers, the great philosopher from Oklahoma, once said that he never met a man that he did not like. I think we could say about President Bush that there was never a man or woman that met the former President that did not like him. He is truly one of the most decent human beings that has ever been in public service for this country. Texas A&M and its private benefactors have raised, or are attempting to raise, over $125 million to build, construct, or operate the Bush Library and the George Bush School of Public Service. The funds that we are offering today to help in that effort are maybe not something that we absolutely have to do, but sometimes I think this Congress should do things that we should do. We should do this to honor a great former Member of the House, a great former Vice President, and a great former President of the United States.

Mr. BARTON of Texas. Mr. Speaker, I rise in very strong support of this very important legislation that has been endorsed and supported by a bipartisan coalition of the House of Representatives. We have the chairman, the subcommittee chairman, I believe, the ranking Democrat on the authorizing committee, on the subcommittee and full Committee of Appropriations; we have both the ranking members and the majority members in support of it. We have both leadership groups in the House in support of it. This is a living memorial to a former Member of the House of Representatives, to a former Vice President and, obviously, to a former President of the United States of America. This money is very consistent with other memorials that have been authorized by the Congress for other Presidents. President Kennedy; we have a program that gives approximately $4 million a year to the Kennedy Center here in Washington, DC. We have the Woodrow Wilson School. We have the Eisenhower College, which received $5 million back in 1968. We have the Hoover Institution, which received $7 million in 1975. We have the Harry S. Truman Scholarship Fund that has received several million dollars from the Government. President Bush is very supportive of this legislation. I have a letter dated June 10 that I will put into the Record. I will read part of it. Your proposal for creating a George Bush Fellowships is excellent. I am delighted to give you my enthusiastic support. The concept of facilitating promising students coming to our school is wholly consistent with the standards for excellence that we have set. I want to reiterate to my colleagues President Bush, who is going to spend approximately 3 days a week at the school interacting with the students, Mrs. Bush, who is also going to spend 3 days a week at the school, did not want a post office named after the President, they did not want a plaque somewhere, they did not want a monument. They wanted money that would go to future generations of America, the best and the brightest. I hope that we will unanimously support this legislation. Mr. Speaker, I include the letter referred to for the Record: June 10, 1996. Charles F. Hermann, Director, George Bush School of Government and Public Service, Texas A&M University, College Station, Texas. Dear Chuck, your proposal for creating a George Bush Fellowships is excellent, and I am delighted to give you my enthusiastic support. The concept of facilitating promising students coming to our school is wholly consistent with the standards for excellence we have set. I would be pleased to have my name associated with future generations who intend to pursue careers in public service. In response to your query about my willingness to interact with those who are awarded these fellowships, let me affirm what I have said in the past: I very much want to be involved on a continuing basis with the Bush School, its faculty, and its students. Barbara and I would particularly enjoy the chance to get acquainted with fellowship students in appropriate ways that would underscore their outstanding merit. By all means, keep me posted on your progress. Sincerely, George Bush.

Mr. BARTON of Texas. Mr. Speaker, will the gentleman yield?

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Chairman, I would hope for a unanimous vote in support of the amendment, and I yield back the balance of my time.

Mr. BARTON of Texas. Mr. Chairman, it is my understanding that the minority also accepts the amendment. With that, Mr. Chairman, I yield back the balance of my time, but I do have a query to the Chair: Is the bruise above the Chairman's left eye going to preclude him from participating in the sporting contest tomorrow evening that he has been preparing for for the last several months?

Mr. BARTON of Texas. I yield to the gentleman from Indiana.

Mr. BARTON of Texas. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, before I talk abut my amendment, I want to compliment the gentleman from Indiana, Chairman Myers, and the gentleman from Alabama, Ranking Member Bevill, for their work, not just this year but in prior Congresses. They have always been a pleasure to work with and been very professional and have helped me not just on this amendment but many other issues in the past, including the late lamented superconducting super collider that they both worked very hard for. Mr. Chairman, the amendment before the body is a straightforward amendment. It would reduce the general administration account in the departmental administration, Department of Energy, by $1 million, from $195 million to $194 million, and transfer that $1 million to the Inspector General account in that same department. The Inspector General office last year actually spent $28 million. The Senate mark this year was at $23 million. The current House mark is at $24 million. So this transfer of $1 million would increase the Inspector General account to $25 million. The Inspector General's office in the department has been very helpful to me in my duties as chairman of the Committee on Oversight and Investigations of the Committee on Commerce, especially with regard to the travel practices of the current Secretary, Mrs. O'Leary. They have uncovered numerous instances of waste of funds. In fact, the Secretary herself in her appearances before my subcommittee has admitted that mistakes have been made and is trying to work to rectify those mistakes. So I would hope that we would accept this amendment, and it is my understanding that both the gentleman from Alabama [Mr. Bevill] and the gentleman from Indiana [Mr. Myers] are prepared to accept it.

Mr. BARTON of Texas. Mr. Chairman, I offer an amendment.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, I again note that the Appropriations Committee is recommending increased funding for the Food and Drug Administration. As chairman of the Oversight and Investigations Subcommittee of the Committee on Commerce, I commend the Committee on Appropriations for its strong support of the Food and Drug Administration, which plays an important role in protecting public health. In addition, I commend my colleagues on the Committee on Appropriations for their oversight activities regarding the Food and Drug Administration. The Subcommittee on Oversight and Investigations has worked diligently in this Congress to identify shortcomings in FDA's performance of its important duties and work with the agency to correct those shortcomings. No problem in agency performance is as vexing as the systematic failure of FDA to meet its statutory duties to timely review various applications and petitions about food, drugs, and medical devices. Indeed, not only does the agency fail to meet its statutory duty for timely reviews, the agency refuses to acknowledge it. In testimony before the Committee on Appropriations, as well as the Committee on Commerce, Commissioner Kessler has boasted of meeting the goals of the Prescription Drug User Fee Act, alluding to objectives he identified and included in letters sent to Congress that were then made part of the legislative history of the Prescription Drug User Fee Act. However, Commissioner Kessler's testimony has consistently ignored the plain language of the Federal Food, Drug, and Cosmetic Act specifying review periods. Given Commissioner Kessler's legal training, one would expect that his testimony might be more mindful of the plain language of FDA's authorizing statute. Timely review of applications and petitions is a matter of very real consequence. Witnesses who have come before the Oversight and Investigations Subcommittee have repeatedly told heart-wrenching stories of their inability to obtain in the United States safe and effective treatments that are available elsewhere. These patients, often fighting life- threatening diseases, are the very personal side of the grim statistics regarding the adverse effect on public health caused by excessive delay in approval of safe and effective drugs and medical devices. There are also economic consequences. Hearing records explain clearly that as approval of medical devices is excessively delayed in the United States, the developers of those devices, principally U.S. firms, are forced by economic realities to begin manufacture of those devices overseas where more timely approvals have been obtained. It is dark humor that a joke told at an international medical device conference observed that if a medical device is approved in the United States, it must be obsolete. These delays not only deny American patients the most safe and effective therapies, but also result in the loss of U.S. jobs. Regrettably, these are not small shortcomings. I urge my colleagues to review a table that lists the statutory deadline for review of certain applications and petitions, as well as the average time that FDA takes to conduct these reviews, according to the latest published FDA reports. I trust my colleagues will share my concerns that agency performance is woefully off the mark. The Committee on Appropriations is to be commended for directing FDA to meet its statutory duties for timely review. I ask unanimous consent that this statement be printed following my remarks. Food Additive Petitions.--Within 180 days (6 months) after filing of a petition, FDA is required to publish a regulation authorizing the use of the food additive or deny the petition. 21 U.S.C. Sec. 348(c). Current ``average time to approval''--48 months. ``Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations for 1996,'' Hearings Before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the Committee on Appropriations, House of Representative, Part 6, 104th Cong., 1st Sess., p. 664 (Mar. 28, 1995) (hereafter ``FY 96 House Agriculture Appropriations Hearings''). Health and Nutrient Content Claim Petitions.--Within 190 days (6.25 months) after filing of a petition, FDA is required to propose regulations authorizing the use of the health or nutrient content claim or deny the petition. 21 U.S.C. Sec. 343(r)(4). Current average review time from filing to issuance of a proposed rule--10 months. 62 Fed. Reg. 296 (Jan. 4, 1996); 60 Fed. Reg. 37,507 (July 20, 1995). Nutrient Content Claim Synonym Petition.--Within 90 days (3 months) after submission of a petition, FDA is required to approve the use of the synonym for nutrient content claims or deny the petition. 21 U.S.C. Sec. 343(r)(4). Current average review time from submission to approval--19.5 months.\1\ FDA Docket No. 94P-0216 (Letter from F. Edward Scarborough, Ph.D., Director, Office of Food Labeling to Douglas C. Marshall, Darigold, Inc. (Oct. 30, 1995)). --------------------------------------------------------------------------- \1\ To date, FDA has received only one synonym petition. --------------------------------------------------------------------------- New Human Drug Applications (NDAs).--Within 180 days (6 months) after filing of an application, FDA is required to approve the human drug or give the application notice of an opportunity for a hearing before FDA on the question of whether the application is approvable. 21 U.S.C. Sec. 355(c)(1). Current average time for ``first action''-- twelve months. Statement by David A. Kessler, M.D., Commissioner of Food and Drugs, Department of Health and Human Resources Before the Subcommittee on Health and Environment, Committee on Commerce, U.S. House of Representatives, p. 4 (May 1, 1996) (hereafter, ``Health and Environment Subcommittee Hearing''). Abbreviated New Drug Applications (ANDAs).--Within 180 days (6 months) after initial receipt of an application, FDA is required to approve the drug or give the applicant notice of an opportunity for a hearing before FDA on the question of whether the applicant is approvable. 21 U.S.C. Sec. 355(j)(4)(A). Current average review time from receipt to approval--34.2 months. Department of Health and Human Services Fiscal Year 1997 Justification of Estimates for Appropriations Committees for the Food and Drug Administration,'' p. 65 (hereafter ``FY 97 FDA Justification of Estimates for Appropriations Committees''). Medical Device Premarket Approval Applications (PMAs).-- Within 180 days (6 months) after receipt of an application, FDA is required to approve the medical device or deny the application. 21 U.S.C. Sec. 360e(d)(1)(A). ``Current average review time''--20 months. Health and Environment Subcommittee Hearing, pp. 9-10. New Animal Drug Applications (NADAs).--Within 180 days (6 months) after filing of an application, FDA is required to approve the animal drug or give the applicant notice of an opportunity for a hearing before FDA on the question of whether the application is approvable. 21 U.S.C. Sec. 360b(c)(1). Current average review time from receipt to approval--39 months. FY 97 FDA Justification of Estimates for Appropriations Committees, p. 83. Abbreviated New Animal Drug Applications (ANADAs).--Within 180 days (6 months) after initial receipt of an application, FDA is required to approve the generic animal drug or give the applicant notice of an opportunity for a hearing before FDA on the question of whether the application is approvable. 21 U.S.C. Sec. 360b(c)(2)(C). Current average review time from receipt to approval--31 months. FY 97 FDA Justification of Estimates for Appropriations Committees, p. 84.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, next week, on July 3, Americans will be preparing to celebrate our independence from the British empire over 200 years ago. They will have another reason to celebrate next week; July 3 is the day in which we become independent from having to work for the Government. It is a sad fact, but a true fact that July 3 is the day in which the cost of all levels of government will finally be paid for. An even more amazing fact, it is not only taxes but also government regulations that we must pay for. In fact, regulations cost more to the average American citizen than the taxes that we pay. I am happy to join with Senator Coverdell in the other body and the gentleman from Texas, Majority Whip DeLay, in this body to be an original cosponsor of Cost of Government Day. I would urge all of my colleagues to join us in this resolution. Let us tell the truth to the American people: Government costs too much, it spends too much money and it wastes a lot of the money that it spends. Let us begin to cut back on taxes, cut back on regulations, and have Independence Day from Government not on July 3 but sometime much earlier in the year.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, on rollcall No. 222, 223, and 224 I was unavoidably delayed by weather problems that affected airline flights from Dallas to Washington. Had I been present, I would have voted ``yea'' on all three votes.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Chairman, I rise to speak in opposition to the amendment. (Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)

Mr. BARTON of Texas. Mr. Chairman, I am reminded of a story that President Abraham Lincoln used to tell. Somebody was about to be hung and the crowd was gathering on the town square and they asked the gentleman about to be hung if he had any last remarks; and he said, if it were not for the honor of the occasion, he would just as soon not be there. If it were not for the honor of having my amendment singled out to be struck from the bill, I would just as soon not be here. I am the author of the amendment to change the name of the National Science Foundation to the National Science and Engineering Foundation. Admittedly, it was a close vote, 23 to 22, but it still was an affirmative vote. I think it is very important that we recognize engineering for its contributions to the American society. Our first President, George Washington, was a practicing engineer. Even in this century, we have had engineering Presidents like President Hoover and President Carter. There are over 6 million practicing engineers in our Nation. So engineers are not a part of science, they are a separate discipline. If you go to any major research university in this country, they have a school of engineering that is separate and apart from their science departments. We have a National Academy of Sciences. We have a National Academy of Engineering. If my colleagues read the annual report of the National Science Foundation, budget summary, fiscal 1997, I read the first sentence, ``The National Science Foundation requests $3.3 billion for fiscal 1997 to invest in almost 20,000 research and education projects in science and engineering.'' Everywhere in the first two pages of the NSF budget summary, where it says ``science,'' it says, ``and engineering.'' All of the various societies of engineering have submitted letters of endorsement to change the name of the National Science Foundation to the National Science and Engineering Foundation. I will submit those for the Record. We have the Institute of Electrical and Electronics Engineers, the American Society of Mechanical Engineers, the American Nuclear Engineering Society, the American Society of Civil Engineers; they have all gone on record specifically endorsing the Barton amendment to change the name from the National Science Foundation to the National Science and Engineering Foundation. There is no cost to this amendment. The Director of the National Science Foundation, Dr. Neal Lane, testified at our budget hearing that there is no cost associated with this. It does not cost anything. It empowers engineers. They are a separate field. It passed in committee on a bipartisan vote in support of it. Mr. Chairman, I would strongly recommend that we defeat the amendment of the gentleman from Michigan [Mr. Ehlers]. Keep the name change as adopted in committee and let us empower engineers. Let us call it the National Science and Engineering Foundation.

Mr. BARTON of Texas. Mr. Chairman, will the gentleman yield?