Posting date: December 17, 2003

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Health Affairs, 10.1377/hlthaff.w3.618
Copyright © 2003 by Project HOPE

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Approval Times For New Drugs: Does The Source Of Funding For FDA Staff Matter?

¹ Daniel Carpenter is a professor of government in the Department of Government, Harvard University, in Cambridge, Massachusetts.
² Michael Chernew is an associate professor of economics in the Department of Health Management and Policy, University of Michigan School of Public Health, in Ann Arbor.
³ Dean Smith is a professor of health policy in the Department of Health Management and Policy, University of Michigan School of Public Health, in Ann Arbor.
⁴ Mark Fendrick is a professor of general medicine in the Department of Internal Medicine, University of Michigan School of Medicine.

^*Corresponding author.

Abstract

The Food and Drug Administration (FDA) has been criticized for injudicious and excessively rapid approval of new drugs as a result of pharmaceutical industry influence. Many critics focus on the Prescription Drug User Fee Act (PDUFA) of 1992, which augmented the FDA’s budget through the charging of user fees. We assess the effect of FDA staffing patterns and attributes of submitting firms on approval times for 843 new drug applications (NDAs) submitted between 1977 and 2000. NDA review times shortened by 3.3 months for every 100 additional FDA staff. The amount of funding for FDA staff appears to be a much more important influence on NDA review time than the source of funding.

Key Words: Pharmaceuticals, Research and Technology, Politics

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