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House Passes FDA Reauthorization, Both Chambers Prepare for Conference

June 1, 2012—The House May 30 approved, 387-5, an amended version of the Food and Drug Administration Reform Act of 2012 (H.R. 5651, H. Rept. 112-495). Sponsored by Rep. Fred Upton (R-Mich.) and cosponsored by Reps. Joe Barton (R-Texas), John Dingell (D-Mich.), Frank Pallone (D-N.J.), Joseph Pitts (R-Pa.), and Henry Waxman (D-Calif.), the legislation reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) for five years and creates new user fee programs for generic drugs and generic biologic drugs.

Originally, the Congressional Budget Office (CBO) estimated that H.R. 5651 would increase the federal deficit by $247 million over 10 years. The cost estimate prompted Rep. Upton to offer a substitute amendment shortening the FDA’s time frame for responding to citizen petitions regarding pending generic (as well as biosimilar) drugs, intended to expedite the process of getting lower-priced drugs to market.

CBO now projects the amended version of the bill will reduce the deficit by $370 million over 10 years, bringing the bill’s cost estimates closer to the Senate version (S.3187), which CBO projects will reduce the deficit by $363 million in the same time period.

The House bill was unanimously approved in subcommittee and it has been praised as an example of successful bipartisan legislation [see Washington Highlights, May 11]. Rep. Upton thanked his colleagues on both sides of the aisle for their bipartisanship and said the bill will “help American patients and innovators, and it will support millions of jobs in an important sector of our economy.”

The Senate passed its version, 96-1, May 24. Both chambers will now come together to begin the conference committee process to reconcile differences and finalize legislation with the goal of delivering a bill to President Obama before July 4. The current authorization for the programs expires Sept. 30, 2012.


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