Billy Tauzin

Mr. TAUZIN

Mr. TAUZIN. The gentleman is correct. Like you, I too want to ensure that unapproved products are available in times of emergency. And while we allow the FDA to make products available during such time of emergency, absent such emergency, current law applies. We do allow for the shipments of such therapies in limited circumstances, namely, where a physician authorizes the continued treatment of an individual who initially received the drug during an emergency. However, this is the only exception. Absent that, present law applies to these unapproved products.

Mr. TAUZIN. Mr. Speaker, I would ask how much time is available on both sides at this point.

Mr. TAUZIN. Mr. Speaker, I commended the gentleman from Virginia (Mr. Tom Davis) and the gentleman from California (Mr. Cox) previously, along with the ranking members for their extraordinary work we did together; and I now ask unanimous consent to yield the balance of my time to the gentleman from Virginia (Mr. Tom Davis) so that Chairman Davis can control the balance of that time.

Mr. TAUZIN. 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 H.R. 2122.

Mr. TAUZIN. Mr. Speaker, I yield myself 4 minutes. Today, Mr. Speaker, the House will address one of President Bush's top initiatives in the war against terror, Project Bioshield. Mr. Speaker, it is absolutely critical that America's public health emergency system be prepared to respond to new and emerging threats, and we are here today to take care of that job. This bipartisan legislation is about the safety and security of American families and of our country. America is stepping up to the profound threat of terrorism and other public health emergencies, and I am proud to report that H.R. 2122 combines smart policy and provides additional resources to prepare the Nation for bioterrorism threats and for other public health emergencies. The chairman and ranking member of both the committees of jurisdiction and the Select Committee of Homeland Security have arrived at this consensus product that is before us today. I would like to thank the gentleman from Michigan (Mr. Dingell), the gentleman from Virginia (Mr. Tom Davis), the gentleman from California (Mr. Waxman), the gentleman from California (Mr. Cox), the gentleman from Texas (Mr. Turner) for their cooperation and hard work on this bill. This bipartisan spirit is similar to last year's effort on the Public Health Security and Bioterrorism Preparedness and Response Act that Senator Kennedy and I had the privilege to move through the Congress last year. Project Bioshield will spur the research and development of new vaccines, drugs, and other countermeasures to deal with these biological, chemical, nuclear or radiological agents that pose a material threat to our Nation's security. The list includes, among other dangerous agents, such things as anthrax, botulinum toxin, the plague, ebola, and other similar viruses, many of which lack any effective treatment or antidote today. The bill before us accomplishes this goal by doing two important things. First, it provides the needed flexibility in a range of areas from government contracting rules to peer review to personnel matters in order to speed up government-sponsored research and development into these deadly agents. Second, it creates a special reserve fund of money for the government to purchase these countermeasures that may ultimately be developed in response to the President's call. Without this clear commitment of funding in future years, private sector companies that are capable of such development simply will not undertake the heavy investment and risk associated with developing products to deal with agents that do not affect significant populations today and hopefully never will. At our urging, the House has already provided an advanced appropriations of $5.6 billion over the next 10 years for this purpose, and this is all consistent with our authorization in the House budget resolution. The bill 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. Under current law, the only way an individual can receive an unapproved product is pursuant to a clinical investigation. But in time of national emergency, when this Nation is under attack, it may be necessary to give such investigational drugs on a large scale basis to millions of Americans. H.R. 2122 provides that if there is such an emergency, and if no adequate alternative therapy is available, the Secretary can authorize the use of a drug, device, or vaccine in such a flexible manner. While we have made improvements to the administration's initial proposal in certain areas, our bill stays close to that original proposal, granting all the additional flexibilities and authorities requested by the President and even expanding them in some cases to further encourage companies to heed our call for innovation. Once again, I want to applaud the leadership of President Bush and the truly bipartisan work of this body across multiple committees of jurisdiction to protect our country and to promote public health security from the many new dangers that we face today. Mr. Speaker, I reserve the balance of my time.

Mr. TAUZIN. Mr. Speaker, will the gentleman yield?

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

Mr. TAUZIN. Mr. Speaker, I insert at this point into the Record of these proceedings a statement of administration policy in strong support of this bill. Executive Office of the President, Office of Management and Budget, Washington, DC, July 16, 2003. Statement of Administration Policy The Administration supports House passage of H.R. 2122, Project BioShield Act of 2003. This bill would implement a Presidential initiative to help spur the development and availability of next generation countermeasures against biological, chemical, nuclear, and radiological weapons. Specifically, H.R. 2122 would: (1) speed the Government's ability to turn promising scientific discoveries into necessary countermeasures by one-third or more; (2) authorize funding to purchase critical new countermeasures targeted against the most worrisome threats; and (3) allow the Food and Drug Administration to make promising treatments quickly available to Americans in emergency situations. Project BioShield is critical for strengthening our ability to protect Americans against biological, chemical, radiological, and nuclear terrorist threats. The Administration notes that provisions on submission of legislative proposals, and of reports on options considered and rejected, should reflect Constitutional principles regarding Executive-originated legislative proposals and protecting Executive deliberations. Mr. Speaker, I again center Congress' attention on the concerns that our colleague from Tennessee (Mr. Wamp) raises regarding the lack of domestic capacity to develop and produce new vaccines and countermeasures, indeed the concern he has that we might end up relying upon foreign sources for these critical supplies. Let me first say that I share that concern about our lack of a robust domestic vaccine industry. I know that the Secretary of Health and Human Services shares that concern. I also know that one of the primary purposes behind Project Bioshield is to help the Nation address this important problem by giving incentives to all companies, but especially our domestic pharmaceutical companies, to invest in this capacity, in this vaccine antidote producing capacity so that we have domestic supplies and domestic countermeasures available without relying upon foreign sources to protect this country in case of a domestic attack. I just read from the Secretary's letter his commitment to do exactly that, to use this Act to make sure that we incentivize the capacity of our country to produce those vaccines and those countermeasures, those antidotes, whatever may be required, in case of the unbelievable attack upon our country with some of these awful agents, and I am confident the Secretary will implement the Act with that goal in mind. We obviously on the Committee on Energy and Commerce will aggressively oversight the implementation of this Act so that we are satisfied that we are, in fact, encouraging domestic corporations to compete for these contracts. Mr. Speaker, I reserve the balance of my time.

Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the gentleman from Georgia (Mr. Norwood), a distinguished member of our committee.

Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the gentleman from Florida (Mr. Bilirakis), the distinguished chairman of the Subcommittee on Health of the Committee on Energy and Commerce, who celebrates his birthday today.

Mr. TAUZIN. Mr. Speaker, I yield 3 minutes to the gentleman from Connecticut (Mr. Shays).

Mr. TAUZIN. Mr. Speaker, I will be happy to speak to that. New subsection (k) permits the President to waive, in writing, only the consent portion of the conditions of authorization set forth in section 564(e) with respect to armed services personnel, and only to the extent that complying with the requirement is not feasible, is contrary to the best interests of the personnel, or is not in the interest of national security. It is not my intent that the President may ever waive pursuant to subsection (k) the other conditions. They are that the individual to whom the product is to be administered is informed, one, that the Secretary has authorized the emergency use of a product, and, two, about the significant known and potential benefits and risks of the use of the product. The committee intends, absent extraordinary circumstances, that such information be provided to individuals prior to receiving the unapproved product. After the gentleman raised these issues with us, we took a closer look at the language, and I acknowledge that there is a crossreference in new section 564(k)(2) that could be confusing. I want to continue to work with the gentleman and the gentleman from New York (Mr. Towns), who I know cares deeply about this issue, along with you and many of us, to make sure that the final version of this bill from the conference that we will have with the Senate, I am sure, provides that our military are informed of the drugs that are given before these drugs are administered. Let me also assure the gentleman from Connecticut that we understand the importance of the protections for military personnel receiving unapproved countermeasures contained in current law, title X, section 1107; and we intend the waiver authority in this bill to be used only in the very extraordinary circumstances that we describe in the bill.

Mr. TAUZIN. Mr. Speaker, if the gentleman will continue to yield, I thank my friend and give him that assurance.

Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from Nevada (Mr. Gibbons).

Mr. TAUZIN. Mr. Speaker, will the gentleman yield?

Mr. TAUZIN. Mr. Speaker, I thank the gentleman and will be happy to enter into a discussion with him. Let me first thank him for the excellent statement he has made. I think the gentleman is correct. I think it is as important to our country as perhaps the Manhattan Project was. I remember when Speaker O'Neill used to remind this House that partisanship ended at the water's edge. He meant to tell us that when it came to protecting our country, we were not Democrats or Republicans, we were Americans. And where the water's edge used to be the boundary of the threats against our country, because of 9-11, we now understand the water's edge is no longer the boundary. Within our country we now face these potential threats. So I thank the gentleman. And, indeed, the bill is designed to do exactly that, to balance those important elements of the equation and to make sure we incentivize the private marketplace, but also provide the public monies, $5.6 billion over 10 years, to make sure we have the available money in a trust fund, through our budget resolution, appropriated through our process, to make sure we can acquire those countermeasures, stockpile them, distribute them around the country, as the Secretary is prepared to do, to make sure that those countermeasures are available. It also balances the need to build in our own country the capability of building those vaccines and countermeasures that otherwise would never be built. Because who would, in the private sector, want to build a vaccine for the plague today, without this particular legislation? So I thank the gentleman.

Mr. TAUZIN. Mr. Speaker, will the gentleman yield?

Mr. TAUZIN. Mr. Speaker, I want to thank the gentleman for that language. The neat thing about the way this bill has been processed is that all through the process Democrats and Republicans have assisted in building it into a much better bill. And the language the gentleman has added to the bill is an extraordinary addition to the bill, and I thank him for it.

Mr. TAUZIN

Mr. TAUZIN. Mr. Speaker, I yield 15 minutes to the gentleman from Wisconsin (Mr. Green) on behalf of the Committee on Ways and Means and ask unanimous consent that he be permitted to control that time.

Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, there were two visions of Medicare prescription drug bills before the House several weeks ago. The vision offered by the Democratic Party is revisited upon us today in this motion to instruct. That vision was one of simply a government program for prescription drugs. It was one that eliminated any real possibility of competitive reform. It was one that literally provided for the government to always make sure that prescription drugs were available. In short, it literally put the government in the business of deciding what prescription drugs, at what price and when they might be available for seniors. There was another vision offered on the floor which was adopted by the House when it rejected overwhelmingly the Democratic vision. The vision that was offered on this side of the House that was finally approved in that long night of voting was a vision that literally said we are going to literally provide a $400 billion drug benefit for seniors. But, as part of the deal, we are also going to require Medicare itself to undergo reforms, to make sure that the Medicare system does not itself go bankrupt or bust the business of government as the years go by. There were predictions, for example, that by the year 2070 if we did not accept the vision of reforming Medicare, of making sure that there were competitive choices available for consumers so that Medicare itself would become more and more efficient, less bureaucratic, more responsive to Medicare doctors and Medicare patients, if we did not do that by the year 2070, entitlements in this country would eat up every single dollar raised from taxpayers, leaving no money to operate this body, the Congress or the courts or the Defense Department or any other vital function of our government. That is the choice we have again in this motion to instruct. The Democratic motion to instruct simply says, adopt that Democratic vision of a government-provided Medicare benefit only with no competition offered to that system and no tension between the private competition offered and the public system to ensure that the public system remains as intensely efficient as possible under the law. So in effect what this motion does is to strike the competitive features of the vision of Medicare reform adopted on the House floor and to rely instead upon government-backed, government-fallback medicine for Americans. Let me state very clearly again. The vision adopted on the floor of the House was to provide $400 billion of government-provided Medicare prescription drug assistance to seniors, to seniors who wanted to stay within the Medicare program or seniors who might want to choose some other competitive private plan that would be offered under that vision. The vision adopted by the House was exactly that, competition, more stores in town, a government store and private stores as well. The vision rejected that is again offered on the floor of the House is government medicine only, government medicine without the competitive choices that seniors should have. This motion to instruct should be rejected. Mr. Speaker, I reserve the balance of my time.

Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, let me point out to my friend from California, the Committee on Energy and Commerce had a chance to look at the Senate- passed bill. My colleagues on the other side offered it in the markup of the Committee on Energy and Commerce, and it was resoundingly rejected by the Committee on Energy and Commerce in markup. I notice my friend did not choose to offer the Senate-passed bill as the final motion on the House floor on the debate just several weeks ago. Instead, they chose to offer their vision instead of the Senate- passed bill. Now you wonder why they claim the Senate-passed bill is such a great bill. Let me also point out the problem I think of this whole Medicare debate and why this bill was so important and why for several Congresses now we have passed Medicare reform and a prescription drug benefits bill over to the other Chamber, never to see them become law. The problem is, why have Medicare prescription drugs not been added to Medicare many, many years ago? Medicine changed many years ago. When Medicare first started, Medicare was all about taking a senior to a hospital and putting them in a hospital bed and caring for them in a hospital. We know that medicine has changed during that period of time. Medicare has not. The whole purpose, the whole reason we have been in this massive, historic debate over Medicare prescription drugs is because no one in past decades before this majority came around chose to modernize Medicare with a prescription drug benefit; and without a prescription drug benefit, indeed Medicare is outdated. It is not up to the task of taking care of senior citizens today. It is built around a premise that we are going to put them all in the hospital. It is not built around the correct premise today that many seniors depend upon prescription drugs to maintain their health, to prevent the need to go to the hospital, to maintain their condition, to prevent the spread of disease that has begun to inflict their bodies, indeed, to make sure that those diseases are kept in some sort of control. Prescription drugs is the way in which so many seniors depend upon health maintenance today. To claim that Medicare is not outdated, when for decades it has not been updated with a prescription drug benefit, is not only wrong, it is, I think, the reason we have had this great debate in this Chamber for the last several Congresses and the reason why this majority is so very proud to say that we finally passed a bill that really has a chance of becoming law. We are going to go now into a conference with the Senate and we are going to debate the issues of whether competition should be a part of this program or whether the government should be the sole provider of this new benefit. We are going to debate in the Senate whether the reforms this House agreed upon are better than the Senate-passed bill which was rejected in the Committee on Energy and Commerce. I think we will win that debate. But we cannot win it if we give up with this motion to instruct and say we will take the Senate bill, which was already rejected in the Committee on Energy and Commerce and not even offered on the floor by my friends on the other side when they had the chance to do so. The bottom line is this motion to instruct takes us backwards. It indeed says, well, Medicare, which has not been updated, which has not been modernized to take care of seniors' real needs today, will be the sole provider forever of health care needs for seniors, when we know that competitive choices ought to be available to them. It says, we will count on the government always to be the provider of these new benefits, and that seniors will not have the choice of going to a better plan if they can find one and, in fact, if one is offered to them in their community. It says, even if we are putting up the cost of the premiums, they will not have that choice. That takes us backwards. We ought not take a backwards step today in this Chamber. We ought to move forward, take on the Senate and defeat the Senate bill, as we did in committee in the conference, and come out with a better bill that looks much more like the House bill passed on the House floor several weeks ago. Mr. Speaker, I reserve the balance of my time.

Mr. TAUZIN. Mr. Speaker, I ask unanimous consent to take from the Speaker's table the bill (H.R. 1) to amend title XVIII of the Social Security Act to provide for a voluntary program for prescription drug coverage under the Medicare Program, to modernize the Medicare Program, to amend the Internal Revenue Code of 1986 to allow a deduction to individuals for amounts contributed to health savings security accounts and health savings accounts, to provide for the disposition of unused health benefits in cafeteria plans and flexible spending arrangements, and for other purposes, with Senate amendments thereto, disagree to the Senate amendments, and agree to the conference asked by the Senate.

Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume. Let me reiterate again, the motion to instruct, to all Members of the House who are paying attention to this debate, basically says to the Senate and House conferees: accept the Senate language, take the Senate bill, take the Democratic vision that was rejected overwhelmingly on this House floor, and make it the conference report. It basically recedes to the Senate provisions and eliminates the basic competitive elements that were approved on this House floor in this historic vote just several weeks ago. My friend from Wisconsin made the case, but let me make it again. The argument that we need to instruct the conferees to adopt the Senate provision because somehow the seniors who are sickest and eldest in our society are going to lose Medicare in 2010 is just absolutely wrong. The fact is that they are not going to be driven into a small class of people only covered by Medicare because, as my friend points out, the private plans we vision coming into effect have guaranteed issue. They cannot refuse anybody. So if their mother, grandmother, grandfather wants to take one of these private plans because they offer a better, more efficient system of health care than does the Government plan, they will have a right to take it. They cannot be denied no matter how old or how sick they are. Secondly, I want to point out that the basic frame of the bill we passed a couple of weeks ago on the House floor said to the poorest in our society, those living below 135 percent of poverty that we are providing this new prescription drug benefit virtually free of charge. The only thing they pay is a copay on the drug, but the premiums are free. The deductibles are covered. In fact, we provide for the poorest in America the best benefit of any Medicare prescription drug plan that we had yet considered on the floor of the House until just 2 weeks ago. So the poorest are covered. Those who are the sickest who want to choose a better plan have guaranteed access to those plans under the bill we adopted on the House floor. This motion to instruct is virtually, literally saying that we should reverse the votes we took on the House floor; we should approve that Democratic vision of the government trying to do it all in a system that is already failing because it is beginning to go bust and a system that is too bureaucratic and literally too complex for even the providers to follow today. Our bill provides for bureaucratic reform, regulatory reform, guaranteed issue for seniors who are the sickest to choose whatever plan they want. And most importantly, it provides for free coverage in effect for all those living under poverty for this new prescription drug benefit program. So to argue that we have to adopt this motion to instruct for the oldest and the sickest and the poorest in our society is not quite accurate. On the contrary, the motion to instruct simply says go into debate with the Senate and yield in advance, give in to the Senate that there will be no competition in Medicare, give into the Senate that the government is going to be the provider of this new benefit and seniors will never have the kind of choices that Members of this body have in choosing the kind of health care plans that best suit them in their conditions, in their health care needs, in their particular problems as they find it and as they make choices in the future. Let us reject this motion to instruct just as we rejected the Democratic vision on the floor several weeks ago. Mr. Speaker, I reserve the balance of my time.

Mr. TAUZIN. Mr. Speaker, I yield myself just 1 minute to respond to my good friend. First of all, I am not sure who was in this Chamber way back when Medicare was first adopted by the House. I assume my friend, the dean of the House, was here, but I do not know of anybody else who was who currently serves in the Chamber. I can tell my colleagues there were no only dirty looks on this side when it comes to Medicare. We support Medicare, believe in it. My mother depends upon it. As I have often said on this House floor, she is a three-time cancer survivor who loves Medicare. That is why when we wrote this bill we preserved her opportunity to remain in fee- for-service Medicare if she chooses. But I want to give her something else, and that is why this bill provides for competitive choices for her so that she can choose a premium-based insurance program if it is better for her. If she wants to stay under Medicare, she can. In either case, she gets the Medicare prescription drug benefit that was not available to her all of these years until this majority came forward and provided one in this bill. Reject this motion to instruct. Let us go to the conference with the Senate and let us be hopeful and positive that we can negotiate with the Senate a version that will pass the House and Senate and get signed into law. Seniors understand. They are tired of waiting. They are tired of this debate. They are ready for a law that gives them a prescription drug benefit, and so is my mother.

Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Oregon (Mr. Walden).