[Congressional Record Volume 157, Number 172 (Thursday, November 10, 2011)]
[Senate]
[Pages S7382-S7384]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BURR (for himself, Mr. Harkin, Mr. Enzi, Mr. Casey, Ms. 
        Mikulski, Mr. Alexander, Mr. Lieberman, Ms. Collins, Mrs. 
        Hagan, and Mr. Roberts):
  S. 1855. A bill to amend the Public Health Service Act to reauthorize 
various programs under the Pandemic and All-Hazards Preparedness Act; 
to the Committee on Health, Education, Labor, and Pensions.
  Mr. BURR. Mr. President, I rise today to highlight the introduction 
of important bipartisan legislation to reauthorize the Pandemic and 
All-Hazards Preparedness Act of 2006 and the BioShield Special Reserve 
Fund. I am pleased to be joined by my colleagues, Senators Harkin, 
Enzi, and Casey. I thank them for their efforts and leadership on this 
important legislation. It

[[Page S7383]]

is clear that my colleagues share my dedication to strengthening and 
enhancing our Nation's ability to be prepared for and respond to all 
hazards that may confront us.
  As we introduce legislation to strengthen and improve our Nation's 
medical and public health preparedness and response programs, it is 
appropriate to reflect on the progress we have made to date, the 
seriousness of the threats facing our Nation, and the work that remains 
to be done if we are going to be prepared to respond to the full range 
of threats, whether naturally occurring, like an influenza pandemic, or 
a deliberate bioterrorism attack.
  During the 109th Congress, I chaired the Subcommittee on Bioterrorism 
and Public Health Preparedness. Building on the lessons learned from 
Hurricane Katrina and September 11, Congress took a hard look at how we 
could better prepare and respond to public health and medical 
emergencies. The Subcommittee held multiple public hearings, 
roundtables, and meetings, and Congress received significant input from 
public health officials, medical experts, emergency managers, 
biotechnology companies, and stakeholders from across our nation. These 
actions culminated with the passage of the Pandemic and All-Hazards 
Preparedness Act of 2006.
  Through the Pandemic and All-Hazards Preparedness Act, Congress 
empowered the Department of Health and Human Services with the tools it 
needs to protect the American people more effectively and efficiently 
in response to a public health emergency. This law established the 
Office of the Assistant Secretary for Preparedness and Response, or 
ASPR, to unify the Department's preparedness and response programs and 
mission and answer the critical question of ``who is in charge?'' when 
it comes to medical and public health preparedness and response. Since 
its inception, ASPR has carried out significant preparedness and 
response planning and coordinated response efforts with federal, State, 
and local public health partners.
  The Pandemic and All-Hazards Preparedness Act of 2006 also 
established the Biomedical Advanced Research and Development Authority, 
or BARDA, to speed up the development of countermeasures--such as 
vaccines or treatments--to protect Americans against a potential 
chemical, biological, radiological, or nuclear terrorist attack, or 
other public health emergency, such as a pandemic influenza. PAHPA also 
gave BARDA the ability to make mile-stone based payments through the 
BioShield Special Reserve Fund--a $5.6 billion medical countermeasure 
procurement fund established by Congress in 2004 to provide assurances 
of the federal government's commitment to purchasing medical 
countermeasures if companies embarked on years long development of 
these life-saving products. Even without full funding, BARDA has been 
able to identify promising countermeasures and support the critical 
advanced research and development necessary for making these products 
available to the American people. Thanks to BARDA and the investment we 
have made over the last few years, our nation was much better 
positioned to quickly respond to the H1N1 pandemic influenza two years 
ago.

  I am very proud to have authored this important bipartisan law five 
years ago and I am proud to have again joined with Senators Harkin, 
Enzi, and Casey in a bipartisan manner to tackle the serious challenges 
that remain in ensuring our nation is prepared to respond to all-
hazards. In recent weeks, Congress has been reminded of the urgency of 
our work in this area. Last month, the WMD Center published a 
comprehensive Bio-response Report Card evaluating our nation's 
preparedness against potential bioterror attacks. This report noted 
that while we have made progress, the U.S. Government received ``Ds'' 
and ``Fs'' in certain areas associated with responding to large-scale 
biological attacks that terrorists like Al- Qaida or others may seek to 
perpetuate against us. This report and recent analysis by the 
Government Accountability Office calling for improvements to our 
nation's medical countermeasure programs are a serious wake-up call 
that cannot go unaddressed. The American people expect the President 
and Congress to do all we can to prevent an attack, and in the event of 
an attack, be prepared to respond in order to save lives. When it comes 
to protecting the American people, failing grades are unacceptable.
  Our work on this important legislation has been guided by sound 
principles. First and foremost any improvements to existing programs 
and authorities must be targeted and strategic and based on the lessons 
we have learned over the past five years, including the H1H1 pandemic 
and disasters at home and abroad. We must ensure the continuity of 
critical medical and public health preparedness authorities and 
programs, including the BioShield Special Reserve Fund. Given the 
significant fiscal challenges facing our nation, we must also ensure 
that we are maximizing the taxpayer resources supporting this critical 
preparedness mission, as well as ensuring appropriate transparency and 
accountability for these resources and programs. Finally, we must 
ensure a robust medical countermeasure enterprise, from the research 
bench to the points where patients receive care, including by ensuring 
that the U.S. Food and Drug Administration's regulatory tools and 
pathways reflect modern-day threats.
  The Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 
would strengthen and enhance our nation's medical and public health 
preparedness and response programs and go a long way in addressing many 
of the short-comings and concerns raised by GAO and the WMD Center, as 
well as other stakeholders. Our legislation provides the ASPR with 
enhanced policy oversight and coordination of medical and public health 
preparedness and response programs to further unify our response in the 
event of a public health emergency. Our legislation also ensures an 
appropriate emphasis on chemical, radiological, biological, and nuclear 
threats as part of an all-hazards approach to our National Health 
Security Strategy. Our legislation ensures that an emphasis on 
strategic initiatives to advance medical countermeasures and community 
resiliency are incorporated into the National Preparedness Goals, as 
well as the importance of considering the unique needs and 
considerations for individuals at-risk in the event of a public health 
emergency.
  Our legislation would reauthorize the National Disaster Medical 
System, the volunteer Medical Reserve Corps, the Emergency System for 
Advance Registration of Volunteer Health Professionals, the Public 
Health Emergency Preparedness and Hospital Preparedness Cooperative 
Agreement Programs, and the Strategic National Stockpile. Targeted 
flexibility under our bill will help our State and local partners 
optimize community resiliency at the local level. By reauthorizing the 
BioShield Special Reserve Fund, our bill sends the clear signal that 
the U.S. Government remains committed to purchasing medical 
countermeasures.
  The critical role that FDA plays in our medical countermeasure 
enterprise has become clear over the past five years and our 
legislation strengthens this enterprise by making targeted improvements 
to FDA's role in this important endeavor. For example, our bill allows 
the Secretary to make medical countermeasures under review by the FDA 
available in limited circumstances based on either a declared emergency 
or an identified threat, and requires the material threat posed by the 
agent of agents for which a product under review is intended is 
considered when reviewing medical countermeasures for approval, 
clearance, or licensure. We will stretch taxpayer dollars even further 
by allowing FDA to extend the shelf life of products stockpiled in the 
Strategic National Stockpile. Our legislation also charges FDA with 
promoting medical countermeasure expertise and developing regulatory 
science tools to advance the review, approval, clearance, and licensure 
of these products. By enhancing the scientific exchange between FDA and 
medical countermeasure stakeholders, FDA will not only be identifying 
problems, but an active partner in solving them to ensure our nation 
has the medical countermeasures necessary to protect the American 
people. Medical and public health preparedness and response programs, 
including the availability of medical countermeasures, are a matter of 
national security and our bill will ensure the appropriate, senior-
level national security focus on these issues.

[[Page S7384]]

  In addition to reauthorizing PAHPA, I am pleased to also introduce 
the Medical Surge Capacity Act, critical legislation that I hope we can 
include in the final version of PAHPA reauthorization. I thank Senators 
Harkin, Enzi, and Casey for working with me on this important 
bipartisan legislation that makes strategic improvements to current law 
to enable the Secretary of Health and Human Services to target and 
issue waivers under Section 1135 of the Social Security Act in as 
timely a manner as possible based on the circumstances of an emergency. 
This legislation authorizes HHS to implement waivers as soon as either 
a public health or national emergency is declared, and enables the 
Secretary to institute 1135 waivers in ``host areas'' outside of a 
declared disaster area, but into which patients are being evacuated to 
receive care.
  I look forward to continuing to work with my colleagues in Congress 
and the administration to do the important work of reauthorizing PAHPA 
and BioShield in order to ensure our nation is as prepared as possible 
in the event of the unthinkable, whether natural, or man-made.
  Mr. HARKIN. Mr. President, today it gives me great pleasure to 
introduce the Pandemic and All-Hazards Preparedness Act Reauthorization 
of 2011--also known as the PAHPA Reauthorization of 2011--with a 
bipartisan group of Senators that includes Senators Burr, Casey, Enzi, 
Mikulski, Alexander, Hagan, Collins, Lieberman, and Roberts. This 
reauthorization builds on a record of bipartisan cooperation to 
strengthen our ability to respond to and prepare for medical and public 
health emergencies over the past decade.
  Based on lessons learned since the original PAHPA legislation was 
signed into law in 2006, this reauthorization continues to support the 
progress made by the Federal Government and its State and local 
partners to protect its citizens during public health and medical 
emergencies. It also proposes a number of targeted changes that will 
improve our ability to address a variety of threats to the public 
health of our Nation.
  Such threats are diverse in origin and include exposure to chemical, 
biological, radiological, or nuclear agents. Sometimes these threats 
occur naturally--the 2009 H1N1 pandemic influenza, for example--or they 
can be the result of malicious intent--such as the deliberate release 
of anthrax in 2001. A recent and very challenging example is the 
radiation leak that occurred at the nuclear plant damaged by Japan's 
massive earthquake.
  It is not just known threats that place the health and well-being of 
Americans at risk; there are just as many emerging or unknown threats 
against which protection is critical. Because the impact of these 
threats could be catastrophic, it is imperative that we continue to 
strengthen our Nation's ability to adequately prepare for a public 
health emergency.
  Building our Nation's response capacity requires close collaboration 
among Federal, State and local governments; hospitals and health care 
providers; businesses; schools; indeed, all Americans. I have long 
taken the Federal Government's role in being prepared for a public 
health emergency public health preparedness as it is calledvery 
seriously.
  We have made tremendous progress in preparedness during the last 
decade, but this reauthorization provides additional flexibility to 
State and local governments to more efficiently use Federal resources 
in preparing for public health emergencies. For example, this bill 
reauthorizes the Public Health Emergency Preparedness Cooperative Grant 
Program, which provides critical resources to State and local public 
health agencies, and streamlines requirements making it easier for them 
to meet program requirements and target resources.
  Our ability to be prepared for a public health emergency also depends 
on the advanced development and procurement of medical countermeasures. 
These are the vaccines, therapies, and diagnostics needed to prevent or 
respond to a bioterrorism event or other public health emergency. In an 
effort to ensure that we have the appropriate medical countermeasures, 
we need to continue to support innovative research into promising new 
products and ensure that products are readily available during a time 
of emergency. We also need to address the scientific challenges of 
identifying safe and effective medical countermeasures when human 
trials are not available or ethical.
  This bill addresses a number of these concerns and provides greater 
certainty for biotech companies that operate in this space and 
continues to build on partnerships between the private sector and the 
Federal Government to ensure that we have the appropriate medical 
countermeasures to prepare for or respond to a public health emergency.
  Underlying all of our preparedness activities is the issue of how we 
ensure that our most vulnerable citizens will be protected should 
disaster strike. We know that many populations--including individuals 
with disabilities, seniors, and children--may have unique needs that we 
have the responsibility to address during a public health emergency. In 
the past, when faced with catastrophic events, we have too often seen 
such needs go unmet. Now we must use lessons learned to ensure more 
efficient, effective, and equitable responses in the future.
  Something that I am especially proud of is that the PAHPA 
Reauthorization of 2011 requires that these individuals are an 
integrated part of our preparedness efforts. This means that we 
continue to address the unique needs of at-risk populations--such 
providing information in a way that it is understandable to all 
Americans, including those with cognitive limitations--and plan for 
these unique needs when it comes to drafting preparedness plans and 
conducting preparedness drills and exercises. This bill truly focuses 
on addressing the need of our most vulnerable citizens by considering 
them as critical part of our overall preparedness planning--not as an 
afterthought.
  This bill represents a true bipartisan effort and had the support of 
a number of important stakeholders. For example, we have already 
received the endorsements of the Alliance for Biosecurity, American 
Academy of Pediatrics, and the American Dental Association. In the 
coming days and weeks, we expect many more endorsements. Because the 
bill is so critical to our ability to prepare for and respond to public 
health and medical emergencies, I urge my colleagues to support this 
bill.
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