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Washington Highlights

Senate Panel Approves FDA User Fee Reauthorization

April 27, 2012—The Senate Health, Education, Labor, and Pension (HELP) Committee April 25 approved by voice vote bipartisan legislation to reauthorize the Food and Drug Administration (FDA)’s user fees programs for approval of prescription drugs and medical devices. The committee adopted a manager’s amendment offered by Committee Chair Tom Harkin (D-Iowa) and Ranking Member Mike Enzi (R-Wyo.), building off previous drafts under discussion by the committee [see Washington Highlights, April 20].

The unnumbered Food and Drug Administration Safety and Innovation Act would reauthorize the drug and device user fee programs through FY 2017.  The legislation also would create user fee programs for generic drugs and generic biologic drugs.  In addition, the legislation permanently would authorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), both of which are intended to encourage manufacturers to conduct pediatric studies of their products.

The legislation also includes an AAMC-endorsed proposal to require the Secretary of Health and Human Services to issue proposed regulations establishing a unique device identifier system no later than Dec. 31, 2012, finalize the regulation within six months of the close of the comment period, and implement such a system within two years for certain devices [see Washington Highlights, March 23].

Meanwhile, the House Energy and Commerce Committee postponed an April 26 markup of similar legislation until May 8 to afford more time to reach a bipartisan consensus on the bill.

The current authorization for the programs expires Sept. 30.


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
Senior Legislative Analyst, Govt. Relations
Telephone: 202-903-0806