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Both Chambers Clear FDA Reauthorization for President’s Signature

June 29, 2012—The Senate June 27 voted, 92-4, to adopt the House amendment to the Food and Drug Administration Safety and Innovation Act (S. 3187), meeting the goal both chambers set to have the legislation ready for the president’s signature before July 4 [see Washington Highlights, June 22].  The current Food and Drug Administration (FDA) user fees are set to expire Sept. 30 of this year.

The agreement has been praised as an example of bipartisan, bicameral legislation. In a joint statement, Senate Health, Labor, Education, and Pensions (HELP) Committee Chair Tom Harkin (D-Iowa) and Ranking Member Michael Enzi (R-Wyo.) said that the bill “is a great example of the kind of progress we can achieve when we work together, and we are grateful to all of our colleagues for their efforts in this process.”

In addition to expediting FDA review of generic applications  and protecting patients from drug shortages, the senators add that the bill will “help FDA do its job more effectively, increasing accountability and transparency, so U.S. companies can innovate and compete in the global marketplace.”


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