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FDA and the President’s FY 12 Budget Request: What to Watch For

Two upcoming events this week will set the tone for FDA appropriations for the next two years. On Monday, the President will release his request for FY 12 funding. On Tuesday, the House will begin consideration of HR 1, which provides for continuing appropriations for the remainder of FY 11 (through September 30, 2011).

This column previews the President’s FY 12 request; a separate column will analyze the House situation for FY 11. These are based on analysis I have done for the Alliance for a Stronger FDA, which is the leading advocacy voice for increased appropriations for FDA. I urge you to e-mail me at sgrossman@strengthenfda.org for more information about joining.

The President’s FY 12 budget request is the opening salvo in what is likely to be a long, hard fight over next year’s appropriation. While Congress is unlikely to accept the President’s recommendations, it is critically important to FDA whether the President suggests increases, flat funding or cuts for the agency.

If past years’ patterns repeat, there will be confusion on Monday after the release of the President’s budget request. Many of the numbers being discussed by media and commentators will be inaccurate or out of context.

Here are the most common sources of misunderstanding:

·        What base is being used in the President’s request? A proposed $100 million increase (or decrease) for FY 12 means something different if it is based on the FY 10 funding level (which is also the current FY 11 CR level) or on the President’s FY 11 request.


If the President follows past practice, the FY 12 budget request will be based on his FY 11 budget request. Because Congress never adopted it and never will, it would mean that every number in the President’s request has to be adjusted before determining its impact.   


·        For FDA specifically, are user fees included in any given budget number? If comparisons are made between budget numbers, are they both calculated the same way?


As recently as this past week, the media was confused because the House appropriations committee’s initial FDA numbers for the FY 11 CR referred to the President’s FY 11 funding request. The intended reference was to the budget authority (BA) appropriations request (monies to be drawn from general revenue). However, some analysts attempted to interpret the House position by referencing the President’s FY 11 request that included both BA appropriations and user fees.


·        The President’s budget request for FDA usually appears larger because it includes revenue from user fees that are proposed, but not authorized. In many cases, the proposed user fees have been submitted to Congress year after year, although they will never be adopted.


·        The President’s budget request is distorted by the inclusion of tobacco user fees, which represent $450 million in agency income in FY 11. While BA comparisons are not affected by these monies, they make any increase in total funding for the agency look much greater that it really is. The tobacco program is distinct and self-funded. Its growth in no way helps FDA meet its traditional public health mission.  

In terms of timing, the House and Senate want to resolve FY 11 before devoting much time to FY 12. A fast schedule (probably unrealistic) for FY 12 funding would be: 

·        Hearings in March/April, 2011

·        Subcommittee and full committee mark-ups in April/May

·        Final floor action and House/Senate conference agreements in June and July

·        Under this schedule, no bills (or only conference reports) would require action in September.

More likely, there will continue to be sharp disagreements between the House and the Senate on funding levels, delaying the passage of FY 12 funding bills until summer or September. FDA Matters will continue to keep you posted.


For purposes of disclosure: I am one of the founders and Deputy Executive Director of the Alliance for a Stronger FDA. It is the only multi-stakeholder group devoted to education and advocacy to increase the appropriated resources available to FDA. Members include patient and consumer groups, professional societies, research advocacy groups, associations, companies, consultants and individuals. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.


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