Health Affairs

Posting date: October 18, 2005

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Health Affairs, 10.1377/hlthaff.w5.469
Copyright © 2005 by Project HOPE

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A Proposal For Financing Postmarketing Drug Safety Studies By Augmenting FDA User Fees

Daniel Carpenter ^1*

¹ Daniel Carpenter is a professor and director of graduate studies in the Department of Government, Harvard University, in Cambridge, Massachusetts.

^*Corresponding author.

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.

Key Words: Business Of Health, Consumer Issues, Legal/Regulatory Issues, Pharmaceuticals, Research And Technology

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