Health Aff (Millwood). 2005 Jul-Dec;Suppl Web Exclusives:W5-469-80.

A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

Source

Department of Government, Harvard University, Cambridge, Massachusetts, USA. dcarpenter@latte.harvard.edu

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.

PMID:: 16234281; [PubMed - indexed for MEDLINE]

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A proposal for financing postmarketing drug safety studies by augmenting FDA use...
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A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

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