Healthy Skepticism Library item: 8798

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

Carpenter D.
A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.
Health Aff (Millwood) 2005 Jul-Dec; Suppl:
http://content.healthaffairs.org/cgi/reprint/hlthaff.w5.469v1

Abstract:

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.

Keywords:
Publication Types: Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S. MeSH Terms: Drug Industry Drug Toxicity* Financing, Government* Research/economics* United States United States Food and Drug Administration*