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The House Committee Approves FDA User Fee Reauthorization Bill

May 11, 2012—The House Energy and Commerce Committee May 10 unanimously approved bipartisan legislation (H.R. 5651) to reauthorize the Food and Drug Administration (FDA)’s user fee programs. The bill includes titles to reauthorize the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which facilitate the review and approval of life-saving and life-improving drugs and medical devices, as well as titles authorizing the new Generic Drug User Fee Act (GDUFA) and Biosimilars User Fee Act (BSUFA), which will help expedite approval to better benefit the American people.

Further, the bill permanently authorizes the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), which foster the development of prescription drugs for children and safe use of drugs by children. The bill also includes language to encourage interaction with industry and improve transparency, regulatory reforms, and the drug approval process.

The Energy and Commerce bill includes AAMC-endorsed language to require the HHS Secretary to release proposed regulations on a unique medical device identification system no later than 120 days after enactment. However, the House-committee bill does not include language in the Senate HELP Committee-approved bill requiring the regulation be finalized within 6 months of the close of the public comment period and implemented no later than 2 years after the regulations are finalized [see Washington Highlights, April 27]. 

Committee Chair Fred Upton (R-Mich.) applauded both Republicans and Democrats for finding common ground on the bill which is “essential in getting new treatments to patients and creating American jobs.”

The bill was approved by voice vote by the Energy and Commerce Subcommittee on Health May 8, where subcommittee chair Joseph Pitts (R-Pa.) said the bill will “ensure that FDA has the resources and reforms needed to speed new drugs, devices, and treatments to those who are ill” by making the drug approval process “more transparent, more consistent, and more predictable.” Chairman Pitts also noted that the legislation will not only benefit patients, but it will help the United States remain the preeminent leader in drug and device development and manufacturing.

The Senate Health, Education, Labor, and Pensions (HELP) Committee approved its version of the bill (S. 2516) April 25, and it is reported that both the House and Senate bills could go to the floor as early as next week.


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