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House, Senate Committees Gear Up for FDA User Fees Reauthorization

April 20, 2012—Committees in both chambers made progress toward reauthorizing user fee programs that supplement the budget of the Food and Drug Administration (FDA) in anticipation of scheduled markups the week of April 23. The Senate Health, Education, Labor, and Pensions (HELP) Committee released a committee print of the bill it will consider April 25, as well as “redlined” versions of drafts it previously circulated for public input [see Washington Highlights, April 6], while the House Energy and Commerce Health Subcommittee unveiled a discussion draft in time for its April 18 hearing on the subject.

The House hearing featured testimony from Director of the FDA Center for Drug Evaluation and Research Janet Woodcock, M.D., Director of the FDA Center for Devices and Radiological Health Jeffrey Shuren, M.D., J.D., and a second panel of industry witnesses. Dr. Woodcock testified that provisions in the committee’s draft to avert drug shortages through expedited review of products may have “unintended consequences” since FDA could potentially prevent the shortages through other means.

Lawmakers and panelists also discussed the importance of achieving an appropriate balance between new responsibilities for the agency and commensurate funding increases, though some committee members expressed skepticism, since 70 percent of the FDA’s budget is provided through an annual appropriation.

In his opening statement, Subcommittee Chair Joe Pitts (R-Pa.) indicated that there “are still some outstanding issues that staff continues to work on, and I hope that they can be resolved before next week’s subcommittee markup.”


Tannaz Rasouli
Sr. Director, Public Policy & Strategic Outreach
Telephone: 202-828-0525

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806