Monday, November 11, 1996
WASHINGTON - The FDA and representatives of the biotechnology
and pharmaceutical industries are deeply immersed in negotiations over the renewal
of user fees, pitting the FDA's desire for more money against industry efforts
to obtain new commitments from the agency to changes that would reduce the time
and money required to bring products to market.
The Prescription Drug User Fee Act of 1992 (PDUFA), which authorizes
FDA to charge fees for reviewing applications to market drugs and biologicals
and sets performance criteria for reviews, expires in September 1997. Both FDA
and industry have a strong common interest in having Congress enact new user
fee legislation. The Act has become a critical source of funding for FDA - which
says it covers 35 percent of the cost of reviewing drugs and biologics and has
funded the hiring of 600 new reviewers - and has shortened review times.
FDA wants to negotiate an agreement on PDUFA with industry by Dec. 20. The agency is under pressure to provide firm financial projections to the Office of Management and Budget in early January for use in President Clinton's budget proposal for fiscal 1997, which must be submitted to Congress by Jan. 20.