Joe Barton

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on this bill.

Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent that of the 20 minutes that I control, the gentleman from Ohio (Mr. Brown) have the right to control 10 minutes of that time.

Mr. BARTON of Texas. Mr. Speaker, I move to suspend the rules and pass the Senate bill (S. 2634) to amend the Public Health Service Act to support the planning, implementation, and evaluation of organized activities involving statewide youth suicide early intervention and prevention strategies, to provide funds for campus mental and behavioral health service centers, and for other purposes, as amended.

Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of S. 2634, as amended. I am pleased that the House is considering this legislation which is authored with the intent to improve access to quality health care to individuals suffering from mental and behavioral health problems that can lead to suicide. Last year, over 4,000 young men and women in our great country resorted to the ultimate act of denial by committing suicide. Senator Gordon Smith of the other body has been the lead advocate for this legislation, and the bill is named in his son's honor, who, unfortunately, committed suicide last year, I think on this date. So we are here under the leadership of Senator Gordon Smith to try to do something legislatively to prevent future young Americans from resorting to suicide. I have had a young staff member on my staff last spring also commit suicide; so while I have not had the sacrifice or the tragedy that Senator Smith has had, I have been touched by suicide on my congressional staff down in Texas. I can tell you, as one would expect, that it is a very devastating experience. It is incredibly painful. It is a pain that is exacerbated when you see how your family and friends are burdened with grief because of an action like this. It is my sincere hope that the legislation the House is considering this evening, which the other body has already passed, will indeed help those who are troubled and are thinking about committing suicide in the future. This bill is a 3-year authorization bill that provides educational and support programs for children at risk of suicide. These suicide programs would be administered through a grant program through the States. It reflects a balanced and reasonable compromise that allows parents to have a direct role in determining whether their children participate in these long-range programs. At the same time, when there is a young man or woman in our country who is actively contemplating suicide, the bill would allow that emergency intervention could be done without any consent so that we stabilize that individual and prevent them from actually committing the suicide act at the time they are contemplating it. The compromise before us this evening does not modify in any way or affect any existing requirement under the No Child Left Behind Act. It is my hope that in the next Congress the House Committee on Energy and Commerce, which I have the privilege to chair, will systematically reauthorize many of the expired programs and even expired agencies at the Department of Health and Human Services. One of those agencies that we intend to look at very closely is the Substance Abuse and Mental Health Services Administration, or SAMSHA, which has primary responsibility to improve mental health services across this country. I am strongly inclined to rework several of the mental health service programs currently in effect at SAMSHA so that we are sure that the funding programs actually produce measurable results and the kind of results we intend those programs to produce. Without a doubt, as a part of our review of the SAMSHA program, I will pay close attention to SAMSHA's work in the area of suicide prevention. Mr. Speaker, I want to thank the subcommittee chairman, the gentleman from Florida (Mr. Bilirakis); the ranking member of the full committee, the gentleman from Michigan (Mr. Dingell); and the subcommittee ranking member, the gentleman from Ohio (Mr. Brown), for their cooperation in this legislation. I would also like to commend the gentleman from Tennessee (Mr. Gordon) and the gentleman from Oregon (Mr. Walden) for their help on the House side in improving this legislation. And, finally, I would like to thank the Speaker of the House and the majority leader for their assistance in expediting this bill as it comes to the floor today. Mr. Speaker, I would encourage my colleagues to support the legislation. Mr. Speaker, I reserve the balance of my time.

Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Nebraska (Mr. Osborne), who has been involved in programs to prevent suicide in Nebraska for a number of years.

Mr. BARTON of Texas. Mr. Speaker, could I ask since the distinguished gentleman from New Jersey has yielded to me the balance of his time, how much time that means I now have.

Mr. BARTON of Texas. Mr. Speaker, I reserve the balance of my time.

Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the gentleman from Nebraska (Mr. Osborne) who has been directly involved in these programs.

Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the gentleman from Oregon (Mr. Walden).

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, on Tuesday, July 13, 2004, on the floor of this House, Representative Hinchey of New York made several statements about Daniel E. Troy, Chief Counsel of the FDA. Allegations were leveled against Mr. Troy that he took unprecedented action regarding the FDA's involvement in the submission of briefs in product liability cases. His actions were neither unprecedented nor unusual. In a letter dated July 15, 2004, to Chairman Bonilla, five former FDA chief counsels--two of them Democrats--state, Mr. Troy's actions in this regard are neither ``radical'' nor ``even novel.'' The FDA must have the ability to carry out the responsibilities Congress has given the Agency. His interest in those cases is to vindicate FDA's authority over medical product risk communication and to safeguard the agency's primary jurisdiction. As Chief Counsel for the FDA, Mr. Troy appears to have acted completely within the scope of his duties and obligations. In order to address the allegation that Mr. Troy acted inappropriately, I would like to submit a copy of that letter for the Record. July 15, 2004. Re Hinchey amendment to cut $500,000 from the appropriations for the FDA Office of Chief Counsel. Hon. Henry Bonilla, Chairman, Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Committee, House of Representatives, Washington, DC. Dear Mr. Chairman: The undersigned comprise all of the former Chief Counsel to the Food and Drug Administration (in both Republican and Democratic Administrations), except for one who is currently an attorney in the Office of the General Counsel of the Department of Health and Human Services. We are writing to recommend reconsideration of the amendment to the FDA appropriations bill by Representative Hinchey of New York on the floor of the House of Representatives, which would reduce the appropriation for the FDA Office of Chief Counsel by $500,000 and would increase the appropriation for the Division of Drug Marketing, Advertising, and Communications in the FDA Center for Drug Evaluation and Research by a corresponding amount. We support additional funds for the Division of Drug Marketing, but we believe that the reduction of the appropriation for the Office of Chief Counsel and Representative Hinchey's reasons for penalizing that Office cannot be supported. FDA's Office of Chief Counsel performs critical functions in the administration and enforcement of the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. The substantial reduction in the funding of that Office, therefore, would materially impair its ability to meet the needs of its client, FDA. Such impairment would be contrary to the public interest. Representative Hinchey's reasons for penalizing the Office of Chief Counsel and criticizing FDA Chief Counsel Daniel E. Troy are set forth in the House Debate on the FDA appropriations legislation as reported in 150 Cong. Rec. H5598-TI5599 (July 13, 2004). Representative Hinchey states that Mr. Troy ``has taken the agency in a radical new direction'' by submitting amicus curiae briefs in cases in which courts have been asked to require labeling for pharmaceutical products that conflicts with FDA decisions about appropriate labeling for those products. Representative Hinchey characterizes this activity as a ``pattern of collusion between the FDA and the drug companies and medical device companies'' in a way that has ``never happened before.'' These characterizations are inaccurate. In Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973), the Supreme Court agreed with the briefs filed by the Department of Justice on behalf of FDA that the agency has primary jurisdiction over new drug issues. In Jones v. Rath Packing Co., 425 U.S. 933 (1977), the FDA took the position in an amicus curiae brief submitted by the Department of Justice that federal food labeling requirements preempt inconsistent state requirements, and the Supreme Court agreed. In subsequent private tort litigation, FDA has taken the position, through amicus curiae briefs filed by the Department of Justice, that FDA decisions regarding drug product labeling and related issues preempt inconsistent state court determinations, and the courts have agreed. E.g., Bernhardt v. Pfizer, Inc., 2000 U.S. Dist. Lexis 16963 (November 16, 2000); Eli Lilly. v. Marshall, 850 S.W. 2d 164 (Texas 1993). All of this was to protect a uniform national system of food and drug law. All of it occurred before Mr. Troy assumed his current position. In none of these cases did any court request FDA's opinion. Thus, there is ample precedent for the actions that Mr. Troy has recently been undertaking. His action is not radical or even novel. The amicus curiae briefs filed by the Department of Justice at the request of Mr. Troy protect FDA's jurisdiction and the integrity of the federal regulatory process. There is a greater need for FDA intervention today because plaintiffs in courts are intruding more heavily on FDA's primary jurisdiction than ever before. In our judgment, Mr. Troy's actions are in the best interests of the consuming public and FDA. If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to the public health, and FDA's ability to advance the public health by allocating scarce space in product labeling to the most important information would be seriously eroded. By assuring FDA's primary jurisdiction over these matters, Mr. Troy is establishing a sound policy of national decisions that promote the public health and, thus, the public interest. We therefore recommend that the $500,000 cut from the appropriations for the FDA Office of Chief Counsel be restored. Sincerely yours, Peter Barton Hutt (1972-1975). Richard A. Merrill (1975-1977). Richard M. Cooper (1977-1979). Nancy L. Buc (1980-1981). Thomas Scarlett (1981-1989).

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Chairman, I thank the distinguished subcommittee chairman, the gentleman from Louisiana (Mr. Baker); and I want to commend the full committee chairman, the gentleman from Ohio (Mr. Oxley), for bringing this bill to the floor. There have been some issues about how to get it to the floor, and I am happy to report that we were able to work those out. The committee I chair was given a sequential referral, which we handled very expeditiously on Friday while we were not in session, so we were able to move on this bill. I think the policies in the bill are a fair compromise between those who think all stock options should be expensed and those who think no stock options should be expensed. The gentleman from Ohio (Mr. Oxley) and the gentleman from Louisiana (Mr. Baker) and others on the Committee on Financial Services have given us a compromise that sets a finite number of the most senior management team whose options should be expensed. So I am happy to support the bill. I would encourage all Members to vote for the bill and hope that we can move it to the other body and hopefully get a positive vote on this piece of legislation in the other body. So on behalf of the Committee on Energy and Commerce, we are happy to cooperate with our friends on the Committee on Financial Services to bring this bill to the floor.

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may consume. (Mr. BARTON of Texas asked and was given permission to revise and extend his remarks, and include extraneous material.)

Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on S. 15.

Mr. BARTON of Texas. Mr. Speaker, I yield such time as he may consume to the gentleman from California (Mr. Cox), the distinguished chairman of the Select Committee on Homeland Security.

Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the great volunteer, the gentleman from Tennessee (Mr. Wamp). (Mr. WAMP asked and was given permission to revise and extend his remarks.)

Mr. BARTON of Texas. Mr. Speaker, I believe I have 4 minutes remaining. I yield that time to the gentleman from Virginia (Mr. Tom Davis), the chairman of the Committee on Government Reform, and ask that he control the balance of the Committee on Energy and Commerce time.

Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Michigan (Mr. Rogers), a member of the committee.

Mr. BARTON of Texas. Mr. Speaker, the Senate recently joined the House in passing one of President Bush's top legislative initiatives for this Congress, Project Bioshield. The House passed a similar bill in July 2003 by a strong bipartisan vote of 421 to 2. I want to commend our colleagues in the Senate for working with us after the House passed its legislation to provide a bill that will be acceptable to both bodies. The bill largely reflects H.R. 2122, the bill that passed the House last year. Revisions in the Senate were made in close consultation with the House committees of jurisdiction. This is a bicameral and bipartisan product. On the House side, I want to thank the gentleman from Louisiana (Mr. Tauzin), my predecessor as chairman of the committee, who is on the floor this evening, for his strong leadership; and I would also like to thank the gentleman from California (Mr. Cox), the gentleman from Virginia (Mr. Tom Davis), the gentleman from Michigan (Mr. Dingell), the gentleman from Texas (Mr. Turner), and the gentleman from California (Mr. Waxman) for their cooperation and hard work on this bill. The bipartisan spirit reflected in this legislation is similar to the effort of the last Congress on the Public Health Security and Bioterrorism Preparedness and Response Act and also on the Homeland Security Act. We can be proud of this product, and America can be confident in our commitment to make the right investments and smart policy choices to meet the challenges and to protect our Nation's public health. Project Bioshield will spur the research and development of new vaccines, new drugs and other countermeasures to deal with those biological, chemical, nuclear, or radiological agents that pose a material threat to our national security. This list includes anthrax, the plague, ebola and other similar viruses, many of which lack any effective treatment or antidote today. The bill provides increased flexibility in a range of areas, from government contracting rules and peer review to personnel matters, in order to speed up government-sponsored research and development into these deadly agents. It would also authorize a special reserve fund of money, authorized in advance, for the government's purchase of those countermeasures that ultimately are developed in response to the President's call. This latter feature is the most important because, without this clear commitment of funding in future years, private sector companies that are capable of such development will not undertake the heavy investment and risk associated with developing products that deal with agents that do not affect significant populations today and hopefully never will. Congress has already provided the advance appropriation of $5.6 billion over the next 10 years for this purpose, consistent with our authorization in the House budget resolution. The bill before us also provides new authority to the Secretary of Health and Human Services to authorize, in times of emergency, the use of unapproved products whose benefits in treating or preventing infection outweigh the risk of using those products. Under current law, the only way an individual can receive an unapproved product is pursuant to a clinical investigation. In a time of national emergency, however, it may be necessary to give such investigational drugs on a large-scale basis to millions of Americans. The bill before us today says that if there is such an emergency, if no adequate alternative therapy is available, then and only then the Secretary can authorize the use of such a drug, device, or vaccine in a flexible manner. I applaud the leadership of President Bush and the truly bipartisan work of both bodies across multiple committees of jurisdiction to protect our country and to promote public health security from the many new dangers that we face today. I would urge my colleagues to support the bill and look forward to President Bush signing into law another of his major homeland security initiatives. At this point in the Record, I will insert an exchange of letters between the gentleman from California (Mr. Thomas) and myself on this subject. House of Representatives, Committee on Ways and Means Washington, DC, July 13, 2004. The Hon. Joe Barton, Chairman, Committee on Energy and Commerce, 2125 Rayburn House Office Building, Washington, DC. Dear Chairman Barton: I am writing concerning S. 15, the ``Project Bioshield Act of 2004,'' which is scheduled for floor consideration on Wednesday, July 14, 2004. As you know, the Committee on Ways and Means has jurisdiction over matters concerning health issues. Specifically, Section 9 of the bill provides a waiver for application of Section 1867 of the Social Security Act, known as the Examination and Treatment for Emergency Medical Conditions and Women in Labor Act. Section 9 allows hospitals and other providers to transfer unstable patients during a declared emergency period or pursuant to a state emergency preparedness plan by waiving hospital requirements under Medicare, and thus falls within the jurisdiction of the Committee on Ways and Means. However, in order to expedite this legislation for floor consideration, the Committee will forego action on this bill. This is being done with the understanding that it does not in any way prejudice the Committee with respect to exercising its jurisdictional prerogatives on this or similar legislation. I would appreciate your response to this letter, confirming this understanding with respect to S. 15 and would ask that a copy of our exchange of letters on this matter be included in the Congressional Record during floor consideration. Best regards, Bill Thomas, Chairman.

Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the gentleman from Arizona (Mr. Shadegg), the distinguished whip of the Committee on Energy and Commerce.

Mr. BARTON of Texas. Mr. Speaker, I yield such time as he may consume to the gentleman from Louisiana (Mr. Tauzin), the distinguished former chairman of the Committee on Energy and Commerce, who in a very true sense is a principal author of this piece of legislation and who has toiled tirelessly for the last several years to have it passed.

Mr. BARTON of Texas. Mr. Speaker, pursuant to the order of the House of Tuesday, July 13, 2004, I call up the Senate bill (S. 15) to amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures, and ask for its immediate consideration.

Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the distinguished gentlewoman from Florida (Ms. Ginny Brown-Waite), a former president pro tempore with the Florida Senate who chaired the Homeland Security Select Committee in the Florida Senate.

Mr. BARTON of Texas. Mr. Speaker, could I inquire as to how much time remains that I am controlling?

Mr. BARTON of Texas

Mr. BARTON of Texas. Mr. Chairman, I have before me dueling charts about this amendment. If you believe this chart that the gentleman from New York (Mr. Sweeney) has put out, my State is disadvantaged by the bill before us. If you believe this chart that the distinguished subcommittee chairman of the appropriations subcommittee has put out, my State is disadvantaged by the amendment of the gentleman from New York (Mr. Sweeney). Now, both of the gentleman's charts are honorable. So this is a question literally that is a 50/50 question, and they are both right. The debate that we have had tonight is one of those debates that reminds me of the Founding Fathers' debate when we were putting our Constitution together, because you had the rural States that thought everything should be done on a State basis, the little States; and then you had the urban States that thought everything should be done on a population basis. The result was the Great Compromise, where the House of Representatives is based on population and the Senate is based on each State gets two votes. Now, earlier tonight one of the members of my committee, the gentleman from New York (Mr. Fossella), rose and made a point of order on part of this bill that had a funding formula that was legislating on an appropriations bill for about $3.4 billion, and that point of order was sustained. As the gentleman from Texas (Mr. Turner) has pointed out and the gentleman from California (Mr. Cox) has pointed out, the chairman and the ranking member of the Select Committee on Homeland Security, their committee and the committee that I chair, the Committee on Energy and Commerce, have reported a first responder bill that is waiting to come to the floor. So the vote on this is really a coin flip. But in this case, I think we should go with the subcommittee chairman, the gentleman from Kentucky (Mr. Rogers), and oppose the Sweeney amendment, knowing that between now and conference with the other body, we are going to have to come up with a formula similar to the one that our Founding Fathers did with the Great Compromise between the big States and the little States, where we have a pool of money that is based on one man-one vote, and then we have another pool that is based on need with some sort of a grant application process. I am going to work on that from the authorization level, and I know many others are willing to. So I think this is really one of those debates where both sides are going to win, because the ultimate result is going to be a formula that is different than the current formula. But for this vote tonight, I urge a ``no'' vote on the amendment offered by my good friend, the gentleman from New York (Mr. Sweeney).

Mr. BARTON of Texas. Mr. Chairman, I move to strike the requisite number of words. (Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)