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FDA, SOTU, and the President’s Budget Request

The President’s State of the Union (SOTU) address gave no clues as to the fate of the FDA budget for FY 11 (begins October 1, 2010). Both the general and specific details for the agency await the February 1 release of the President’s budget request.

While the House and Senate have control over the final amount that FDA receives, the President’s request is the baseline against which the Congress works. FDA Matters is pleased to offer a guide to interpreting this first stage of the FY 11 appropriations process.

What the State of the Union didn’t tell us. There was hope that the President would make reference to FDA or touch upon food safety. This didn’t occur and there was almost nothing on public health in the address. Even a reference to cancer research did not lead to a mention of support for NIH.

The President announced a three-year freeze on discretionary domestic spending, followed by inflationary increases for the rest of the decade. Within this, some agencies and programs will continue to grow, while others will need to be cut substantially or eliminated. Other than to exclude defense and veteran’s affairs, the President did not give any indication of who would be favored with budget increases.

What to expect when the President’s budget request is released. It will be confusing. Increased revenue from existing and new user fees is likely to be included in totals showing that FDA is growing. This will mask whether the non-user fee budget authority (BA) appropriations (public funds) will increase under the President’s request.

Media often report straight from the OMB summary sheets, so don’t believe any reported numbers unless they recognize the distinction between user fees and BA appropriations. Another potential point of confusion is whether the user fees that fund the new Tobacco Center will be represented as providing more resources to FDA.

The distribution of any new funds among the FDA functions is also important. It is possible, for example, for food safety to receive increases while the rest of FDA is flat-funded.

Looking strictly at BA appropriations, FDA received $2.35 billion for FY 10. Based on year-over-year inflation in FDA costs, the agency needs an increase of $120 to $140 million just to maintain current staffing and program levels. Any less will mean cutbacks within the agency.

It is possible the President’s request will include new responsibilities for FDA. Unless separate additional funding is provided, this will also hinder efforts to strengthen the agency.

For comparison purposes, FDA received a $306 million increase in FY 10. The Alliance for a Stronger FDA is recommending a $500 million increase for FY 11.

What Congress does next. Just as the President has weighed FDA against competing priorities, so must Congress. Action will accelerate through the Spring, with hearings, mark-ups and negotiations. Congress will be trying to get appropriations done by September 15, well before the elections.

Why advocacy is essential to funding the FDA. The Alliance for a Stronger FDA has 180 members and represents all FDA stakeholder groups: consumer and patient groups, health professional societies, associations, companies and individuals. Former FDA commissioners and Secretaries of HHS have chosen to be honorary members and support efforts to provide better funding for FDA.

The Alliance has been a potent force over the last 3 years by successfully reversing a decade of budgetary neglect of FDA. The Alliance needs your support to continue its work in what appears to be a very rough year. For information about becoming a member, please write to me at sgrossman@StrengthenFDA.org.


For purposes of disclosure, I am one of the founders of the Alliance for a Stronger FDA and serve as deputy executive director. The Alliance is not affiliated in any way with FDA Matters or with my consulting practice, HPS Group, LLC.

An earlier column with additional background:

Can FDA Withstand the FY 11 Budget-Cutters?

December 6th, 2009

The President’s FY 11 budget request is likely to be deeply constrained. Having advocated successfully for a number of costly initiatives, President Obama will need to show that he can also reduce the deficit. He asked Cabinet secretaries to submit their budget requests at a no-growth level and an alternative budget on the assumption that their Department might be reduced by 5% overall. Read the rest of this entry »

One Response to “FDA, SOTU, and the President’s Budget Request”

  1. The President’s budget request is always an exercise in magical thinking–where cuts are portrayed as increases and dollars are “spent” that will never be received. FDA has is particular twists and turns because of user fees….and because of the decade of neglect tyhat ran from the late 90’s to a a few years ago. Also, FDA’s mission keeps expanding.

    CQ Today reported this afternoon that the President’s budget will assume that cap and trade (clean air) legislation will be adopted. As result, hundreds of billions of revenue will be available to pay for specific programs and/or reduce the annual deficit over the next 10 years. Probablility of passage is considered slim, but the “revenue” will make the budget look better than it is. Here is the story: http://www.cqpolitics.com/wmspage.cfm?docID=cqmidday-000003287086

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