The House sent an Agriculture/FDA appropriations bill to the Senate June 16 without an amendment requiring FDA to base its regulations and guidance on "hard science," focusing the debate on the numbers.

In H.R. 2112, approved on a 217-203 vote, the numbers leave the FDA budget essentially flat at $3.68 billion, a nominal $3 million increase from fiscal 2011, according to Appropriations Committee calculations. Increases in user fees because of inflation and other adjusters are used to offset a $285 million decrease in direct funding from the Treasury.

This halts the recent upward trend of agency funding, which rose in FY '11 by $418 million from FY '10 (Also see "FDA Budget To Rise By $418 Million In FY 11 As Congress Decides To Cut Spending Elsewhere" - Pink Sheet, 12 April, 2011.).

Inactivity In The Senate

Funding action now switches to the Senate, where the Democratic majority is open to higher spending levels.

Appropriations legislation is in limbo there, however. That chamber has not approved a budget resolution setting funding limits for the government, so the appropriations subcommittees have been given no 302(b) allotments and no markups have been scheduled for the various appropriations bills.

Sen. Herb Kohl, D-Wis., who heads the Senate Agriculture/FDA appropriations subcommittee, continues to view FDA as one of his highest priorities, according to an aide, but is not yet discussing his goals for funding the agency.

One controversy was eliminated by the House when H.R. 2112's "hard science" provision, proposed in committee by Rep. Denny Rehberg, R-Mont., because of concerns about the potential for FDA to restrict the use of antibiotics in animals, was stripped from the bill (Also see "House Approps Bill Would "Harden" Science Requirements For FDA Rules, Guidance" - Pink Sheet, 1 June, 2011.).

Rehberg's provisions was deemed to be legislative in nature and therefore could not be included in an appropriations measure.

Rep. Fred Upton, R-Mich., chairman of the Energy and Commerce Committee, which writes FDA's authorizing legislation, says he will follow up on Rehberg's concerns and his panel "will continue to be vigilant in ensuring federal regulators are not putting their personal bias ahead of proper, scientifically supported policy."

H.R. 2112 provides $1.03 billion for the Center for Drug Evaluation and Research and related field activities, and $328 million for the Center For Biologics Evaluation and Research and related field activities. Prescription drug user fees, which help fund CDER, CBER and other portions of the agency, total $856 million.

-Cathy Dombrowski (c.dombrowski@elsevier.com )

FDA Appropriations Debate Moves To Senate, And From "Hard Science" To Harder Numbers

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