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Friday, July 6, 2012

FDA User Fees and the Regulation of Drugs, Biologics, and Devices: Comparative Analysis of S. 3187 and H.R. 5651

Susan Thaul, Coordinator
Specialist in Drug Safety and Effectiveness

Erin Bagalman
Analyst in Health Policy

Amalia K. Corby-Edwards
Analyst in Public Health and Epidemiology

Judith M. Glassgold
Specialist in Health Policy

Judith A. Johnson
Specialist in Biomedical Policy

Sarah A. Lister
Specialist in Public Health and Epidemiology

Amanda K. Sarata
Specialist in Health Policy

UPDATE: On June 18, 2012, the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce distributed the text of an agreement that combined provisions of S. 3187 [ES], as passed by the Senate on May 24, 2012, and H.R. 5651 [EH], as passed by the House on May 30, 2012. The full House passed the new version by voice vote under suspension of the rules on June 20, 2012. On June 25, 2012, the Senate voted for cloture to limit debate on that bill, S. 3187 [EAH], the Food and Drug Administration Safety and Innovation Act of 2012 [hereinafter referred to as “the agreement”]. The Senate is expected to vote on the agreement sometime the week of June 25, 2012. For information on selected features of the agreement, see the Introduction of this report. 

The Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce have worked for more than a year developing Food and Drug Administration (FDA)-related legislation, versions of which both chambers passed in the last week of May 2012. S. 3187 (the Food and Drug Administration Safety and Innovation Act) and H.R. 5651 (the Food and Drug Administration Reform Act of 2012) each include provisions that would affect the regulation of human drugs, biological products, and medical devices, along with several agency-wide administrative or miscellaneous items. Majority and minority committee leaders have expressed the desire to get a completed bill to the President before July 4, 2012.

The impetus to the timing of these bills is that current authority for FDA to collect fees under the Prescription Drug User Fee Amendments (PDUFA) of 2007 and the Medical Device User Fee Amendments (MDUFA) of 2007 will expire on October 1, 2012, unless reauthorizing legislation is enacted before then. Member statements at committee hearings indicated no opposition to reauthorization and very little comment about changes to the current user fee programs. Because Members of Congress generally consider the user fee reauthorizations to be must-pass legislation—for example, the user fee revenue accounts for more than half of the agency’s human drug program budget—they have used these bills as vehicles for numerous additional measures.

The introduction to this report highlights selected features of S. 3187 [EAH], the agreement, relative to S. 3187 [ES] and H.R. 5651 [EH]. The remainder of this report provides, in a series of 14 tables, comparisons of the provisions in S. 3187 [ES] and H.R. 5651 [EH], presented generally in the order in which they appear in the Senate bill, the first to be reported by committee. Each table addresses a broad topic (e.g., human device regulation) and is preceded by narrative discussing the policy and legislative context of the table’s provisions.

Date of Report: June 26, 2012
Number of Pages: 100
Order Number: R42564
Price: $29.95

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