House Passes Bioterrorism/PDUFA Legislation in 425-1 Vote

Washington, D.C. (May 22, 2002)—The House of Representatives today voted 425-1 to approve “The Public Health Security and Bioterrorism Preparedness and Response Act,” which combines counter-bioterrorism measures and renewal of the Prescription Drug User Fee Act (PDUFA). The bill, which cleared a House-Senate conference Tuesday, is slated for a Senate vote Thursday.

“The five-year PDUFA renewal will ultimately help transform the promise of the Human Genome Project into direct medical benefits for patients suffering disorders such as Alzheimer’s and Parkinson’s disease, various genetic diseases, cancer, and autoimmune diseases,” said BIO President Carl B. Feldbaum. “BIO fully supports passage of this legislation.”

“We commend Representatives Tauzin and Dingell and Senators Kennedy and Frist, who authored the underlying bioterorrism bills, and the members who served on the conference and worked diligently to ensure this legislation, which is critical to the nation’s health and security, moved forward,” said Feldbaum.

PDUFA Changes Minor

The PDUFA renewal that emerged from conference contains only minor changes from the original proposal the FDA submitted in March.

“This legislation retains the recommendations reached by BIO and the FDA with only minor revisions, and thus user fees will increase substantially, giving the FDA the ability to hire scores of new medical review officers,” said Steve Lawton, BIO’s vice president of regulatory affairs. “The FDA agrees to improve first-cycle review performance by establishing good review practices, and they will, for the first time, allow for the use of independent experts to provide advice on complex scientific issues.”

Bioterrorism Legislation ‘A Good First Step’

The sweeping bioterrorism legislation provides funding to boost state and local preparedness; conduct research and development on anti-bioterrorism agents; and enhance controls on biological agents, food and drinking water.

“This legislation is a good first step,” said Brent Erickson, BIO’s vice president for industrial and environmental biotechnology. “It provides benefits to states and first responders, and increases the national stockpile of antibiotics and vaccines.”

Approved drugs and biologics were exempted from a set of new tracking requirements for biologics and toxins in the conference bill; the Department of Health and Human Services will set up an exemption process for investigational products. Companies that “import for export” biologics or food will be subject to new tracking burdens, but these requirements, too, were modified in conference.

The matter of regulating H1-B visa holders’ access to potential bioterrorism agents was left unresolved. “Earlier versions of the legislation would have prevented such workers from handling these agents at all,” said Erickson, “but legislators sensibly decided instead to direct federal agencies to develop new regulations; BIO will be engaged in those discussions.”

Though slated for a Thursday vote, the bioterrorism/PDUFA bill could pass the Senate as early as today. President Bush is expected to sign the legislation.

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

###