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President’s Request for FDA for FY 13 Expected Monday

February 10, 2012

On Monday (February 13), the Office of Management and Budget (OMB) will release the President’s Budget Request for FY 13. Unofficially, this marks the official beginning of the FY 13 appropriations cycle. No matter whether the House or the Senate agree or disagree with the President’s direction or numbers … the baseline is the President’s Request. House or Senate positions are always stated in terms of the President’s request.

The President’s budget will come out in stages on Monday — probably about mid-morning the first documents will start to appear on the OMB web site and then eventually on the HHS and then the FDA web sites. Referring to the FDA portion as “FDA’s numbers” can be a bit misleading — the FDA section of the “Justification of Estimate for Appropriations Committees” was 621 pages last year. There will be descriptions of new initiatives, performance measures calculated for ongoing initiatives, and numbers sliced up into different categories by program, function, etc. The most valuable information is contained in the three “all-purpose” tables, which are usually found around page 65 to 70 of the document. One table covers budget authority (BA) appropriations, one covers user fees, and the third one covers all funding.

If you are interested, check the FDA’s web site around noon: there will probably be information about when Commissioner Hamburg will make an announcement about the budget and answer questions from reporters and stakeholders. (This is usually sometime between 2 and 4 p.m.) I recollect this being done as a conference call, but it is possible that it might be a web feed this year.

As soon as possible, but probably about mid-afternoon, the Alliance will send out a press release describing our position and providing an initial analysis of the budget authority (BA) appropriations request from the President. At this point, we don’t know how FDA will do. All we know for sure is that the overall federal budget will be very tight and that we have heard that a number of programs are likely to be cut below their FY 12 levels. We are hopeful that FDA will do much better than that.

Based on the way the President’s budget request has been presented the last few years, we expect the Administration to claim a substantial increase in FDA funding, far above the actual proposed increase in appropriated funding. This is done by making no distinction between the level of taxpayer funding (BA appropriations) and increases in user fees. Further, the user fee numbers will be based on both current user fees and any new ones being proposed, some of which may not become law. In one recent year, it was claimed by the President that FDA would be receiving a 23% increase, of which only 6.5% was a proposed increase in appropriated funding and not all of the user fee dollars were eventually authorized.

There may be several other ways in which “the budget request as presented by OMB” (and reported initially by some media) may be confusing and not fully accurate. For example, for FY 12, FDA eventually received an increase in BA appropriations of $50 million, very close to what the President initially requested. However, we received many questions from press and Alliance members because the increases in programs actually totaled $72 million, reported as:

  • $39 million to begin implementation of the Food Safety Modernization Act,
  • $20 million for advancing medical countermeasures, and
  • $13 million for mandatory rental payments.

The differential, not apparent in any column or table (or many summaries) was that Congress also accepted FDA’s proposed base reduction of $22 million for administrative and contract savings ($72 million minus $22 million equals a net increase of $50 million).

There are a few other oddities about the way the President’s budget request is presented … and we will try to straighten all of them out for you. So we urge you to keep an eye out for our Alliance press release and analysis, which will also be posted on this web site as soons as possible on Monday. If you have further questions, please don’t hesitate to let us know … we will get you answers as quickly as possible.

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

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