Monday, April 14, 1997
The biotech and pharmaceutical industries last week
provided Congress with proposals worked out with the FDA for the
reauthorization of the Prescription Drug User Fee Act (PDUFA), as
well as a 20-page outline of targets for legislative intervention
where the industry and the agency have been unable agree on the
broader issues of FDA modernization.
both the Biotechnology Industry Organization and the Pharmaceutical
Research and Manufacturers of America, Amgen Inc. Chairman and CEO
Gordon Binder told the Senate Labor and Human Resources Committee
that industry is not asking Congress to go beyond the reforms
outlined by BIO and PhRMA.