Healthy Skepticism Library item: 8326

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wechsler J.
Washington report: Congress debates FDA fees and funding
Pharmaceutical Technology 1997 Apr; 21:16, 18, 20, 22, 24, 26, 28

Abstract:

Issues before Congress related to reform legislation and U.S. Food and Drug Administration (FDA) funding, including the Prescription Drug User Fee Act (PDUFA) of 1992, are discussed. Although the original aim of PDUFA was to ensure that any private sector fees would be used to add resources to improve FDA’s application review process, it was noted that the Office of Management and Budget (OMB) uses the program in attempts to cut FDA’s budget. Another issue discussed is the position by OMB that generic makers should fund the Office of Generic Drugs.