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The Argument for FDA “Exceptionalism”

April 16, 2010


Deputy Commissioner Sharfstein Briefing/Alliance Member Meeting Recap. Yesterday, as part of the Alliance’s quarterly  member meeting, we were honored to have FDA Principal Deputy Commissioner Sharfstein and other FDA leaders brief us on the new FDA-TRACK system. We have attached the slides that accompanied their presentation. When the program was first announced, the Alliance issued a press release and last week’s Analysis and Commentary discussed FDA-TRACK.

2010 Membership Dues. While most Alliance members have paid their dues for 2010, a number of you have not. If you aren’t sure or need another copy of the invoice, please contact Tony Curry by e-mail. Also, we have a new PO box to send dues payments to: PO Box 7508, Silver Spring, MD 20907-7508.


Since last Fall, the Alliance and this column have talked about how difficult this year was likely to be for federal appropriations. This has proven true, with the President proposing flat-funding for most domestic federal agencies. Within that capped amount, there were winners and losers in each agency. Some were proposed for increases, while others needed to be cut or eliminated in order to make the total come out to flat funding.

FDA was one of the “winners” under the President’s request. The agency’s budget request for FY 11 appropriated funding (about $150 million increase) comes to a little more than 6% over FY 10. Since FDA’s costs (staff, benefits, IT, rent) go up nearly 6% per year, this has been characterized as “enough to cover inflation.”

It isn’t quite as simple as that. In the request, FDA was allocated virtually no budget for inflationary costs. Instead, the President proposed new programming (advancing regulatory science, food safety, etc.) that will soak up virtually all the proposed new dollars. To fund inflationary costs AND the new programming, FDA needs at least $250 million in increased appropriated funding.

The Alliance has recommended an even larger amount, a $495 million increase to strengthen and expand FDA’s capacity to fulfill its mission and serve the American public. We believe that the FDA can use these monies well and that it is an amount that can be absorbed in one fiscal year.

Part of the challenge of advocating for increases above the President’s request is that many programs elsewhere in HHS and throughout the federal government will be taking cuts below their FY 10 funding levels. To borrow a phrase from a completely different debate, we need to argue for FDA “exceptionalism” that places strengthening FDA at a higher and more urgent level than other government programs

As part of our effort, we have revamped the Alliance website and will soon be releasing a short advocacy document on FDA’s Impact on the American Economy. A similar paper, being developed now, will be on FDA’s Importance to National Security.  Our goal is to show why FDA is uniquely important. FDA is not just another regulatory agency and not just another public health agency. In good times and bad, FDA needs to be strengthened through increased appropriated funding.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.


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