Critical Care Assessment and Improvement Act of 2011

Thank you, Mr. Pitts, and thank you for your leadership on the committee to allow this bill to come to the floor today. Good news, Mr. Speaker: this bill is bipartisan, it's fiscally responsible, and it will make a positive impact on our Nation's national security.

It's been more than 10 years since 9/11 and the anthrax attacks that followed. And while we haven't had a successful terrorist attack on U.S. soil, our enemies are still working every day to kill innocent Americans. Today the threat of bioterrorism remains very real.

Earlier this year, the bipartisan Graham-Talent Commission warned that the United States it is still ``vulnerable to a large-scale biological attack.''

Thankfully, we have spent the last decade preparing for chemical, biological, radiological, and nuclear threats by developing and stockpiling numerous medical countermeasures to protect American citizens in case of such an attack. Because of these efforts, we now have numerous vaccines and treatments in the Strategic National Stockpile that will save lives, and thousands of lives, in the event of such an attack.

But we have more work to do to be prepared. H.R. 2405 is a bipartisan, fiscally responsible bill that will reauthorize successful biodefense programs at the Department of Health and Human Services while also making some key changes to our Nation's biodefense strategy.

In 2004 Congress passed Project BioShield, which created a market guarantee that prompted the private sector to develop countermeasures for the Federal Government. Because the government is the only purchaser of these countermeasures, it was important to show the private sector we were committed to developing and eventually purchasing these products for stockpile.

Project BioShield Special Reserve Fund has been a critical tool to protect our country against an attack, and this legislation will reauthorize the fund for 5 additional years to continue the Federal Government's commitment to procurement of medical countermeasures. Importantly, this legislation reaffirms that the Special Reserve Fund should only be used for chemical, biological, radiological, and nuclear countermeasure procurement. This is a national security priority, and these funds should never be diverted for other purposes.

In 2006, Congress created a Biomedical Advanced Research and Development Authority, called BARDA, which helped bridge what many termed the ``valley of death'' that had prevented many countermeasure developers from being successful. BARDA was created because we recognize that most of the CBRN countermeasures do not yet exist and medical development countermeasure is a risky, expensive and lengthy process.

BARDA bridges the funding gap between early-stage research and the ultimate procurement of products from the SRF fund from the national stockpile. H.R. 2405 reauthorizes BARDA for 5 years.

In 2006, we also created a unique set of public health programs to assist hospitals, local public health departments, and first responders in their preparedness efforts. Under H.R. 2405, these programs have been reauthorized for an additional 5 years so that we can continue to strengthen our preparedness infrastructure so critical for prevention and dealing with any possible attack.

H.R. 2405 also strengthens the role of the HHS Assistant Secretary of Preparedness and Response. We need to have one leader at HHS that coordinates countermeasure development and stockpiling across all agencies. This bill does that.

Finally, this bill includes important reforms to the Food and Drug Administration, the FDA. The bill strengthens FDA's role in reviewing medical products for national security priorities.

I believe that we've identified biological threats and spent millions in taxpayers' funds to develop countermeasures. The FDA must take a lead role in getting these countermeasures approved.

While we can use many of these products without FDA approval through an emergency-use authorization, the FDA licensure is hugely important and sends an important signal to developers of these new hopeful technologies and immunizations working on next-generation medical countermeasures.

Simply put, medical countermeasures for national security priorities cannot continue to be treated the same way as the next Viagra or Lipitor. FDA must accelerate their review and approval.

It's important for Members to know that this legislation, again, is fiscally responsible. H.R. 2405 does not create any new Federal programs or increase spending in any existing programs. I am pleased CBO has confirmed this in their score. H.R. 2405 creates a 5-year reauthorization of the biodefense programs we know are working while making critical policy changes at HHS to strengthen countermeasure development and public health preparedness.

I would like to thank my colleagues on the Energy and Commerce Committee for their hard work on this bipartisan legislation. Mr. Upton, Mr. Pitts, Mr. Waxman, Mr. Pallone, and their staffs have spent several months helping us develop a bipartisan bill that can be signed into law. I want to especially thank my friends, Gene Green, Sue Myrick, and Anna Eshoo for their work to advance this legislation; and I appreciate your work and counsel along the way, Mr. Green.

I hope we never have to use these countermeasures, Mr. Speaker; but they are critical to the assurance that the public will be protected from an attack, and we must continue to speed development and strengthen our national stockpile. Simply put, we must always be prepared.

I would urge the strong support of H.R. 2405.

Mr. Speaker, I yield myself such time as I may consume.

I am pleased to rise in support of H.R. 2405, the Pandemic and All- Hazards Preparedness Reauthorization Act of 2011. This bill is an opportunity to build a more prepared and resilient public health infrastructure. We all know very well that our Nation continues to face threats that require an ongoing commitment to public health and emergency preparedness, which is why, over the past 10 years, this Congress has placed a high priority on biodefense.

In 2004, with tremendous bipartisan support, we passed the Project Bioshield Act. Democrats and Republicans worked together to establish a process that would help our Nation respond to bioterrorism threats and attacks. We then identified some shortfalls and, in 2006, worked to amend the program by passing the Pandemic and All-Hazards Preparedness Act, also known as PAHPA. Specifically, PAHPA provided the Department of Health and Human Services with the additional authorities and resources necessary to rapidly develop drugs and vaccines to protect citizens from various medical incidents, whether accidental, such as H1N1 outbreaks, or those that are deliberate, such as anthrax attacks.

The programs and activities first established in both the 2004 Project Bioshield Act and the 2006 PAHPA codified and expanded the Federal Government's support for public health preparedness. As a result of these bills and the investments that followed, our Nation is better equipped to respond to bioterrorism threats and attacks.

H.R. 2405 will now help to build on that progress. The bill further facilitates the development of medical countermeasures, and it bolsters the Nation's public health preparedness infrastructure. It strengthens and clarifies the position of Assistant Secretary for Preparedness and Response, who has led the Federal Government's efforts and attempts to improve coordination and accountability.

I was especially supportive of the bill's provisions to identify and dedicate the FDA's role in hazardous events. H.R. 2405 enhances the flexibility of FDA while strengthening their emergency use administrative functions.

These revisions are a significant step forward on a framework for FDA to develop better policies and guidance in emergency situations.

In addition, I was appreciative of the bipartisan effort to address the special needs of pediatric populations in emergency situations. It was clear that there were some gaps in our Nation's public health emergency strategy for children, and I'm confident we took an appropriate approach for filling in these gaps.

So I really want to thank Representative Mike Rogers and Representative Gene Green and their staffs, who authored the base bill and have continued to work to strengthen its provisions.

I would also like to thank the staff of the Energy and Commerce Committee and, of course, my chairman, Mr. Pitts, who collaborated in a bipartisan manner to further enhance the bill. They have worked hard to accomplish the goals of our Members, as well as stakeholders, and to strengthen its provisions. It's been a good bipartisan process and one that I think should be emulated in our subcommittee and full committee in the future.

I would urge all Members to support H.R. 2405.

I reserve the balance of my time.

Mr. Speaker, I yield such time as he may consume to one of the authors of the bill, the gentleman from Texas (Mr. Gene Green).

Mr. Speaker, I yield 2 minutes to the gentlewoman from California (Mrs. Capps).

I have no additional speakers. I urge support for this legislation. It is truly bipartisan.

I yield back the balance of my time.

Mr. Speaker, as a personal aside, this probably won't be the headline on the 6 o'clock news tonight around the country because we're actually agreeing on something, and I think I can associate myself with the remarks of my colleague, the primary sponsor of this bill, as well as he could associate with mine, Mr. Pallone, and Mr. Pitts.

But I rise today in strong support of H.R. 2405, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2011, which will reauthorize certain provisions of the Project BioShield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006, and I'm proud to be an original cosponsor of this legislation.

This legislation was initially passed by Congress to help the U.S. develop medical countermeasures against chemical, biological, radiological, and nuclear terrorism agents to provide a mechanism for Federal acquisition of these newly developed countermeasures.

Our Nation remains vulnerable to these threats because many of the vaccines and medicines that are needed to protect our citizens do not exist. Developing and stockpiling these medical countermeasures require time, resources and research, all of which will be provided under this legislation before us today.

As my colleague from Michigan said, it may not be the bestseller on the market, like so many other pharmaceuticals, but this is something that our country needs.

H.R. 2405 is important to me because the University of Texas Medical Branch-Galveston National Laboratory is literally in the backyard of our congressional district. The Galveston National Lab is the only BSL- 4 lab located on a university campus.

At the lab, the scientists conduct research and develop therapies, vaccines, and diagnostic tests for naturally-occurring emerging diseases such as SARS and avian influenza, as well as for microbes that may be employed by terrorists.

This is exactly the type of research we hope to encourage under the Pandemic and All-Hazards Preparedness Reauthorization Act. As an original cosponsor of H.R. 2405 with Mr. Rogers, I'm really pleased with how quickly we moved this rare bipartisan piece of legislation. I want to thank Mr. Rogers, Chairman Upton, Ranking Member Waxman and Ranking Member Pallone, along with the chair of our Health Subcommittee, Mr. Pitts, Mrs. Myrick, Ms. Eshoo, and Mr. Markey for their work on H.R. 2405.

I strongly urge my colleagues to vote ``yes.''

Mr. Speaker, I rise in support of the Pandemic and All- Hazards Preparedness Reauthorization Act, H.R. 2405, a measure that will improve our nation's medical preparedness and response capabilities.

I am especially pleased to see that this bill takes important steps to ensure that our medical response systems are prepared to care for the critically ill and injured in the aftermath of a public health emergency.

As you can imagine, when we face a health emergency such as a flu pandemic, the critical care delivery system is an integral component of our nation's medical response. Yet, up to this point, critical care medicine has been largely under-contemplated in our national health policy.

Earlier this year, I introduced the bipartisan Critical Care Assessment Act, H.R. 971, with my colleague from Minnesota, Erik Paulsen. This measure seeks to identify gaps in the current critical care delivery model and bolster our capabilities to meet future demands.

I am pleased that the measure before us today includes two important provisions from my bill to improve federal disaster preparedness efforts to care for the critically ill and injured.

Notably, the reauthorization bill adds critical care to the priorities within the nation's medical preparedness goals. When a natural disaster strikes or a pandemic sweeps the nation, the demands on critical care increase exponentially, and I am pleased to see this language that recognizes the importance of treating the critically ill and injured in a public health emergency.

Additionally, the reauthorization bill improves efforts to ensure that the systems we have in place to address surge capacity will work effectively and efficiently during an emergency. Specifically, the bill includes language to provide for periodic evaluation and testing of the databases intended to ensure medical surge capacity.

As we learned during Hurricane Katrina and the 2009 H1N1 pandemic, having a system in place for the effective deployment of needed medical personnel and supplies is vital for the care of the critically ill and injured.

I would like to thank Chairman Upton, Chairman Pitts, and my colleagues on both sides of the aisle for working with me to recognize the importance of critical care preparedness by including these important provisions. I look forward to continuing to work to ensure we have a robust critical care infrastructure.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2405) to reauthorize certain provisions of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act relating to public health preparedness and countermeasure development, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials into the Record.

Mr. Speaker, I yield myself such time as I may consume.

H.R. 2405, introduced by my colleague Mike Rogers from Michigan, would reauthorize certain provisions of the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. These two laws help protect the United States against attacks from chemical, biological, radiological, and nuclear weapons.

Project Bioshield authorized funds for the purchase of medical countermeasures through the Special Reserve Fund and enabled the Secretary of Health and Human Services to authorize the emergency use of medical products. PAHPA created the Biodefense Advanced Research and Development Authority within HHS to help with the development of medical countermeasures and to ensure the communication between HHS and the developers of the medical countermeasures. PAHPA also created a position at HHS to lead the government's efforts on the chemical, biological, radiological, and nuclear weapons preparedness and response, the Assistant Secretary for Preparedness and Response.

Some of these key provisions expired at the end of FY 2011. Since the terrorist attacks of 9/11, we have become more aware of the dangers our country faces and of the lengths to which some may go to inflict harm on us. These provisions must be reauthorized, so I would urge all Members to support this critical piece of legislation.

I reserve the balance of my time.

Mr. Speaker, I yield such time as he may consume to the gentleman from Michigan (Mr. Rogers), the prime sponsor of the legislation.

Mr. Speaker, I would tell the gentleman from New Jersey that I have no other speakers.

Mr. Speaker, this is good, bipartisan legislation. I would like to thank Mr. Pallone, Mr. Green, Mr. Waxman, along with our side of the aisle, for developing and helping move this bipartisan legislation. I urge my colleagues to support it, and I yield back the balance of my time.