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Senate Approves FDA User Fee Reauthorization Bill

May 25, 2012—The Senate May 24 approved, 96-1, the Food and Drug Administration Safety and Innovation Act (S. 3187), an amended version of S. 2516 approved by the Senate Health, Education, Labor, and Pensions (HELP) Committee in late April [see Washington Highlights, April 27].

The bill, co-sponsored by the HELP Committee Chair Tom Harkin (D-Iowa) and Ranking Member Mike Enzi (R-Wyo.), reauthorizes the drug and device user fee programs through FY 2017 and creates user fee programs for generic drugs and generic biologic drugs. 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, 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].

A manager’s substitute amendment, adopted by unanimous consent Wednesday, make a handful of changes to the bill, including adding placeholder language that would establish a national system for tracking drugs throughout the supply chain, known as “track and trace.” Furthermore, provisions in the bill enhance the Food and Drug Administration’s (FDA’s) ability to address drug shortages by requiring early notification of impending shortages and provisions to expedite the development and review of drugs for serious or life-threatening disease and conditions Several senators proposed amendments to the bill, but only a handful were adopted. Sen. Jeff Bingaman (D-N.M.) proposed an amendment intended to get generic drugs to market faster by allowing companies that produce generic drugs to share some of the 180-day marketing exclusivity period; however, 60 votes were required for adoption and the amendment was not approved.

Sen. Harkin praised the bill for being “a shining example of what we can all achieve when we work together” and in an statement Sens. Harkin and Enzi said the legislation will “provide thousands of Americans with access to life-saving medicines and medical devices, and show that Congress can still function when it comes to critical and life-and-death issues like this one.”

Meanwhile, the House Energy and Commerce Committee May 10 unanimously approved its bipartisan version of the legislation (H.R. 5651) [see Washington Highlights, May 11]. The House bill is expected to go to the floor for a vote after Memorial Day. The current authorization for the programs expires Sept. 30.


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

Alexandra Khalife
Legislative Analyst
Telephone: 202-828-0418


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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
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Telephone: 202-903-0806