Monday, January 13, 1997
WASHINGTON - Significant agreements reached by representatives from the biotech and pharmacuetical industries and the FDA in negotiations over a new Prescription Drug User Fee Act (PDUFA) could be jeopardized by deadlocks on some of the most contentious issues, especially the amount of money industry will pay for reviews of drug and biological applications and the scope of the commitments FDA is willing to make in order to receive the industry's financial aid.
Negotiators for the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers Assocation (PhRMA) disagree with FDA not only about the amount of money the agency wants to collect, but also about the philosophy underlying the request. FDA, like virtually all government agencies, is under pressure from both the White House and Congress to reduce its budget. The Office of Management and Budget has asked FDA to trim its current budget by 3 percent in its next request.