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
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.
BREAK IN TRANSCRIPT