[Congressional Record Volume 156, Number 40 (Thursday, March 18, 2010)]
[Senate]
[Pages S1751-S1752]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SPECTER (for himself and Mr. Casey):
  S. 3140. A bill to grant the Secretary of Health and Human Services 
authority to design, construct, and operate facilities for the purpose 
of developing and producing biological products in order to meet 
critical national needs for such biological products, in response to 
potential bioterrorist attacks or naturally occurring pathogens; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. SPECTER. Mr. President, I have sought recognition today to 
introduce the Biosecurity and Vaccine Development Improvement Act, 
which will ensure our country has the resources necessary to protect 
the American people in the event of a disease outbreak or terrorist 
attack.
  Last year, in preparation for flu season and concern about the H1N1 
virus, the Department of Health and Human Services set out to acquire 
120 million doses of vaccines. In August 2009, the department initially 
projected that these doses would be available by mid-October. However, 
only 11 million were obtained by that time, and the 120 million doses 
were not acquired until January 2010.
  The current system consists of government contracts with private 
vaccine manufacturers to produce vaccines. While this lowers overhead 
costs to the Government, the Government is not able to dictate when 
vaccines will be produced or which vaccines will be produced. The 
production of the H1N1 vaccine is good example of the problems that can 
arise without a dedicated Government manufacturing facility for 
vaccines. The delay was due to several problems with the supplying 
companies. For example, one company based in Australia had to produce 
vaccines to meet the needs in Australia before exporting doses to the 
U.S. Another company had to produce their regular seasonal flu vaccine 
before switching to H1N1 vaccine production. This demonstrates the 
critical need to examine the current vaccine system.
  The current system has limitations on the ability to produce vaccines 
related to bioterrorism such as smallpox, anthrax, ebola virus and 
botulism, leaving the U.S. without vaccines and susceptible to 
terrorist attacks. What we want to do is to avoid having the government 
come up short on something like what happened with Katrina where we are 
unprepared for the eventuality.
  I have long been concerned with these issues. Since 2004, when I 
chaired the Labor, Health and Human Services and Education 
Appropriations Subcommittee, with the joinder of Senator Harkin, who is 
now the chair, we appropriated $14.336 billion for pandemic 
preparedness. So you can see that we are talking about very substantial 
funds to meet a very substantial problem. Over the past year, I have 
held a number of meetings about the need for a facility, through a 
public/private partnership, that would afford the U.S. Government 
greater control over vaccine and countermeasure production and 
development. These meetings included Vice President Biden, Secretary of 
Health and Human Services Sebelius and Secretary of Homeland Security 
Janet Napolitano. On August 21, 2009, I chaired a hearing in 
Pittsburgh, PA, to examine the problems our current system faces and 
what can be done to remedy them.
  This legislation would provide funding for a public/private 
partnership vaccine developing and manufacturing facility, determined 
by a competitive bidding process. A public/private facility such as 
this would allow the government to determine what vaccines would be 
produced and would use new technology being developed by General 
Electric to allow rapid change in the vaccines produced. This process 
currently requires extensive cleaning and

[[Page S1752]]

takes weeks, but this new technology includes disposable manufacturing 
equipment to change production quickly and would improve output and 
meet demand.
  This proposed facility would develop and manufacture medical 
countermeasures critical to this Nation's health and security and could 
greatly enhance the U.S.'s vaccine-producing abilities. I encourage my 
colleagues to work with me to move this legislation forward promptly.
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