Mr. Speaker, pursuant to the order of the House of Tuesday, July 15, 2003, I call up the bill (H.R. 2122) to enhance research, development, procurement, and use of biomedical countermeasures to respond to public health threats affecting…
Mr. Speaker, pursuant to the order of the House of Tuesday, July 15, 2003, I call up the bill (H.R. 2122) to enhance research, development, procurement, and use of biomedical countermeasures to respond to public health threats affecting national security, and for other purposes, and ask for its immediate consideration.
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. 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. Speaker, will the gentleman yield?
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.
The gentleman is absolutely correct. The Secretary should perform these reviews as expeditiously as possible once the R&D or procurement has started so as to prevent any exports of countermeasures or countermeasure R&D that could harm our U.S. national security.
Let me thank the gentleman from Massachusetts (Mr. Markey). He raised a great number of concerns as we went true this process. I want to thank the gentleman for the way in which he worked with Members on both sides of the aisle so we cannot only take care of those concerns but produce a great product for the security of our country, and he has added immeasurably to that effort.
Mr. Speaker, I yield 3 minutes to the gentleman from Ohio (Mr. LaTourette).
Mr. Speaker, will the gentleman yield?
The gentleman is absolutely correct. These provisions do not preempt the Public Buildings Act to the extent that it would otherwise apply to such activities.
Mr. Speaker, if the gentleman will continue to yield, that is also correct. The Project Bioshield Act authorizes the construction of highly specialized laboratories, all of which I would expect to be biosafety level 3 or 4 laboratories unsuitable for general purpose use. Project Bioshield does not authorize the construction of ``public buildings'' as defined by the Public Buildings Act of 1959.
If the gentleman would continue to yield, that is also correct. The authority allows the Secretary to take control of these facilities only during, and as necessary to respond to, public health emergencies affecting national security. Under the Bioterrorism Response Act passed last year, a public health emergency can be declared by the Secretary for up to 90 days at a time; and although the Secretary may extend the designation for multiple 90-day periods, it is not the intention of this legislation to allow the Secretary to control a facility for the useful life of that facility.
Mr. Speaker, I yield myself such time as I may consume.
(Mr. TAUZIN asked and was given permission to revise and extend his remarks, and include extraneous material.)
Mr. Speaker, I think we have a couple of other Members who need to do colloquies.
While we are waiting, I wanted to take this time, Mr. Speaker, to refer to a letter received today from the Secretary of Health and Human Services, Secretary Tommy Thompson, dated July 16, 2003; and I want to place the letter in the Record at this point.
The Secretary of Health
and Human Services,
Washington, DC, July 16, 2003.
Hon. Billy Tauzin,
Chairman, Committee on Energy and Commerce, House of
Representatives, Washington, DC.
Dear Chairman Tauzin: Thank you for your leadership on H.R.
2122, the Project BioShield Act of 2003. This legislation is
a critical step toward strengthening our ability to protect
Americans against chemical, biological, radiological and
nuclear threats.
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.
I would like to address two issues that have arisen as the
House takes up this vital priority. First, I share
Representative Wamp's interest in building domestic capacity
to produce countermeasures. In implementing Project
BioShield, I will do everything in my power to purchase from
domestic sources. To have a secure supply, we must build
capacity within the United States and my department is
committed to achieving that objective. The essential purpose
of Project BioShield is to ensure we have necessary and
timely countermeasures. We cannot achieve this goal by
relying on foreign sources. Building a robust domestic
capacity to produce countermeasures is, therefore, at the
very heart of Project BioShield.
Second, I agree with Representative Jackson-Lee that the
Strategic National Stockpile must serve all areas of the
Nation, including rural areas. The Centers for Disease
Control and Prevention has positioned stockpile assets to
deliver needed medical supplies anywhere in the country
within 12 hours. I have a personal understanding of the
challenges that rural areas face and share Representative
Jackson-Lee's interest in rural America. My department is
pro-actively working with state and local health departments
to ensure the effective and timely delivery of stockpile
assets to both rural and urban parts our Nation.
If I can provide you or the members of the Committee with
any further information or if I can otherwise be of
assistance, please do not hesitate to contact me.
Sincerely,
Tommy G. Thompson.
Mr. Speaker, I wanted to refer to it because the Secretary refers to several concerns raised by other Members of the House, of which I also share with him, and I think we will have a colloquy on one of those.
The first is a concern by the gentleman from Tennessee (Mr. Wamp) whose interest is in building domestic capacity to produce countermeasures; and, indeed, the Secretary indicates in his letter that it is indeed his desire to make sure those countermeasures are developed within this country. We cannot achieve the goal of securing our country if indeed we rely upon foreign sources for these measures; and, therefore, the building of robust domestic capacity to produce these countermeasures is at the very heart of the Bioshield Project.
I wanted to assure my friend, the gentleman from Tennessee (Mr. Wamp), that I share the Secretary's comments and his intentions in that regard.
Secondly, the gentlewoman from Texas (Ms. Jackson-Lee) was concerned that strategic national stockpile must be developed in such a way as to serve rural areas of the country, not simply the urban areas of our country, because rural areas can be affected by these bioterrorism threats just as easily, obviously, as urban areas. The Secretary indicates that the Centers for Disease Control and Prevention has positioned stockpile assets anywhere in the country, delivery within 12 hours, in effect making sure that rural areas are not left out of the protection of this bill and the other bioterrorism bills that have passed the House and are part of the Centers for Disease Control stockpiles and distribution system.
So that those two concerns by our colleagues are addressed in this letter, and I wanted to share with those colleagues my agreement with the Secretary on both of those points.
Mr. Speaker, I reserve the balance of my time.
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. 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. Speaker, I am pleased to yield 2 minutes to the gentleman from Georgia (Mr. Norwood), a distinguished member of our committee.
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. Speaker, I yield 3 minutes to the gentleman from Connecticut (Mr. Shays).
Mr. Speaker, will the gentleman yield?
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. Speaker, if the gentleman will continue to yield, I thank my friend and give him that assurance.
Mr. Speaker, I yield 2 minutes to the gentleman from Nevada (Mr. Gibbons).
Mr. Speaker, will the gentleman yield?
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. Speaker, will the gentleman yield?
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. Speaker, I would ask how much time is available on both sides at this point.
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.