A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.
I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augmentation is an achievable, incremental reform that would subsidize information that is now undersupplied in the U.S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system.
Carpenter
Daniel
D
Department of Government, Harvard University, Cambridge, Massachusetts, USA. dcarpenter@latte.harvard.edu
D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D005380:Financing, Government; D012106:Research / Q000191:economics*; D014481:United States; D014486:United States Food and Drug Administration