Forum Session

Who’s Using Whom? Experience with User Fee Programs at FDA
September 23, 2011


Michele J. Orza, ScD


Both the Prescription Drug User Fee Act (PDUFA) and its counterpart for medical devices are due for reauthorization in 2012, and the U.S. Food and Drug Administration (FDA) has just released for public comment the results of its negotiations with industry over the details of the next iteration of PDUFA. Over the two decades since PDUFA was enacted, user fee programs have steadily expanded at FDA. They now help finance a wide range of functions from the review of veterinary drugs to the regulation of tobacco products and account for 37 percent of FDA’s 2012 budget request. User fees can be an attractive mechanism for financing federal programs, especially in tough economic times. But they have the potential to skew agency operations toward fee-supported functions, a concern in particular for regulatory agencies. With both advantages and disadvantages, user fee programs require careful attention to design and ongoing monitoring. This session examined user fee programs at FDA, particularly PDUFA, and their impact on agency operations, the industries FDA regulates, and the public health.


William K. Hubbard, MPA
Former Senior Associate Commissioner for Policy, Planning and Legislation
U.S. Food and Drug Administration
Transition Management Consulting, Inc.

Steven A. Grossman, JD
HPS Group, LLC
FDA Matters: The Grossman FDA Report
Deputy Executive Director
Alliance for a Stronger FDA

Marcia Crosse, PhD
Director, Health Care
U.S. Government Accountability Office

Cole Werble, MA
Senior Editor
The RPM Report
Founding Member
Prevision Policy

Slides from the presentations by Mr. Hubbard, Mr. Grossman, Dr. Crosse, and Mr. Werble are available for download.

Related Materials

For more information on federal user fees, see U.S. Government Accountability Office (GAO), “Federal User Fees: A Design Guide,” GAO-08-386SP, May 2008. See also Office of Management and Budget, Circular No. A-25 Revised, which establishes federal policy for user fees.

For more information on FDA user fees, see the web page for FDA’s Division of User Fees.

See also National Health Policy Forum Session on March 12, 2010, “Not Your Father’s Drug Approval Process: FDAAA and the Evolving Pharmaceutical Marketplace.”

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