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FDA Science Board Calls For Five-Year Budget Doubling

This article was originally published in The Pink Sheet Daily

Executive Summary

Board’s report calls for nearly $1.9 billion in direct appropriations in 2009, up $375 million from 2008, followed by larger increases in each of the following five federal budgets.

FDA Science Board members recommend a nearly $1.9 billion direct appropriation for the agency in fiscal 2009, a $375 million increase over 2008 to be followed by larger increases in each of the following five federal budgets.

The House Energy and Commerce Committee released the report Feb. 26.

Members of the Science Board's Subcommittee on Science and Technology compiled the report in response to a request for input on FDA's funding from Energy and Commerce Chairman John Dingell, D-Mich., and Oversight and Government Reform Chairman Henry Waxman, D-Calif.

"These experts have recommended a funding increase for the FDA that is seven times what the president has proposed," Energy and Commerce Chairman John Dingell, D-Mich., notes in a release.

"We'd be wise to not only heed the warnings raised in their original report, but also use this new information to begin rebuilding this agency's ability to conduct its critical public health mission," Dingell adds.

According to the report FDA's fiscal 2008 budget from direct appropriations is nearly $1.5 billion for salary and expenses, not including rent and facility costs.

The subcommittee members recommend increasing the comparable direct appropriation, which does not include user fees, by $450 million to $2.32 billion for fiscal 2010.

For each of fiscal 2011 through 2013, the subcommittee members recommend a $460 million increase in FDA's direct appropriation, which would raise the agency's budget for salary and expenses to $2.78 billion in 2011, $3.24 billion in 2012 and to $3.7 billion in 2013, according to the report.

"Although significant new resources are needed immediately, there is also need for a phased-in approach, which is why the subcommittee is providing 5-year cost estimates," the subcommittee says.

The subcommittee, led by Science Board Chairwoman Gail Cassell, VP for scientific affairs at Eli Lilly, says it "recognizes that the timing of expenditures will depend on both institutional and market forces."

The subcommittee says it "strongly recommends that a regulatory science business plan be developed within an upgraded science organization led by a new chief scientific officer and new scientific directors in each of the centers," a recommendation included in its December 2007 report to FDA on the agency's scientific capabilities.

FDA touted its fiscal 2009 budget request as a 5.7 percent increase over its current funding provided in an omnibus appropriations package.

However, Sen. Ted Kennedy, D-Mass., a co-author of the FDA Amendments Act, said the proposed $130 million increase for FDA is misleading because the budget figures do not account for inflation and they include user fees that have not yet been authorized.

"In real dollars, the budget would result in a decrease of $72 million in FDA program funding," Kennedy said in a release.

Along with House Oversight and Government Reform Chairman Henry Waxman, D-Calif., Dingell on Feb. 5 asked Cassell to convene members of the Science Board subcommittee and provide advice on whether President Bush's proposed budget will provide sufficient funding to correct problems noted in the subcommittee's report to FDA.

- Malcolm Spicer ([email protected])

[Editor's note: This story appears courtesy of the editorial staff of 1 'The Tan Sheet', your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]

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