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Senate Committee Approves FDA Spending Bill

May 5, 2012—The Senate Appropriations Committee April 26 approved 28-1, the fiscal year (FY) 2013 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies appropriations bill (S. 2375,S. Rept. 112-163) without amendment.

The bill, which skipped subcommittee consideration, includes an appropriation of $2.524 billion for the FDA, an $18.7 million (0.8 percent) increase over the FY 2012-enacted level. Additionally, the FDA budget is supplemented by industry user fees, which the committee estimates will yield $1.385 billion in FY 2013. This addition brings the committee’s total for the FDA to $3.910 billion, a $19.8 million (0.5 percent) increase over the comparable FY 2012 level.

The bill’s user fee estimates include the amounts assumed in the president’s FY 2013 budget request for the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee and Modernization Act (MDUFMA) user fees, which Congress will need to reauthorize before they expire Sept. 30; however, the total does not include potential revenues generated through proposed new user fees, such as those for generic drugs and biosimilars, which are still being negotiated. As a result, the committee’s total for FDA falls short of the president’s recommended $4.486 billion (a $654 million or 17 percent increase over FY 2012) total for the agency, though the committee’s appropriation slightly exceeds the president’s appropriations request of $2.517 billion.

The Senate Health, Education, Labor, and Pensions (HELP) Committee approved its user fee reauthorization bill April 25 [see Washington Highlights, April 27], while the House Energy and Commerce Health Subcommittee is scheduled to consider its version of the legislation May 8. The report for S. 2375 states that the Appropriations Committee will follow legislation authorizing the fees and adjust the bill’s user fee amounts if necessary.


Alexandra Khalife
Legislative Analyst
Telephone: 202-828-0418


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Jason Kleinman
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Telephone: 202-903-0806