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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

House Committee Approves FY 2013 FDA Funding; FDA Reauthorization Progresses

June 22, 2012—The House Appropriations Committee June 19 approved by voice vote the fiscal year (FY) 2013 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies bill providing appropriations for the FDA. The bill is expected to go to the floor the week of June 25.

The bill (H.R. 5973, H. Rept. 112-542), approved by voice vote in subcommittee June 6, provides $2.480 billion for the FDA, a $16 million (0.7 percent) decrease from the FY 2012-enacted level. According to the draft committee report, the bill assumes industry user fees will provide an estimated $1.354 billion, a $62 million (4.8 percent) increase over the FY 2012-enacted level, bringing the FDA’s FY 2013 total to $3.834 billion, a $46 million (1.2 percent) increase over the FY 2012-enacted level. The report notes that committee will make adjustments for the recently approved generic drug and biosimilars user fee legislation, but despite the additional fees the funding level remains lower than the Senate bill and the president’s request [see Washington Highlights, May 4].

Ranking Member Norm Dicks (D-Wash.) said that the legislation “underfunds” the FDA, putting at risk “the agency’s ability to oversee the safety of our food, drugs and medical devices”; however, Committee Chair Hal Rodgers (R-Miss.) said the bill makes “responsible cuts to the FDA.”

Meanwhile, the House June 20 unanimously approved by voice vote an amended version of the Food and Drug Administration Safety and Innovation Act (S. 3187), representing an agreement reached between House and Senate negotiators. In his opening remarks, Energy and Commerce Committee Chair Fred Upton (R-Mich.) applauded both the House and Senate for “working closely together throughout this process to get the job done” and added that the legislation “will make a real difference in the lives of patients as well as support innovators across the country.”

In addition to reauthorizing current user fee program through FY 2017, the legislation authorizes the creation of new generic drug and biosimilar user fees. The bill also includes language from the House measure that would reduce the amount of time for the FDA to make administrative decisions, giving the agency 150 days, rather than 180, to respond to citizen petitions requesting a stay on pending generic applications, including those for generic biologic drugs.

Not included in the bill is proposed language that would establish a national system for tracking drugs throughout the supply chain, known as “track and trace.” However, the bill does include 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].

Additionally, the Congressional Budget Office estimates the final agreement will reduce the deficit by $311 million over 10 years.

The Senate is expected to consider the legislation as early as the week of June 25, keeping both chambers on track to deliver the bill to President Obama before July 4. The current authorization for the programs expires Sept. 30, 2012.

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

Alexandra Khalife
Legislative Analyst
Telephone: 202-828-0418
Email: akhalife@aamc.org

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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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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org