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Advocacy at a Glance

September 9, 2011

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

  • Senate Committee Acts to Increase FDA Funding: On September 7, the Senate Appropriations Committee voted to approve a $50 million increase in FDA’s FY 12 funding above the FY 11 appropriation. This increase stands in stark contrast with the previously-passed House bill, which would cut FDA by $285 million below the FY 11 level. Thus, the Senate position is approximately $335 million higher than the House. A chart comparing the two bills is attached. It also includes comparisons to FDA’s FY 10 and FY 11 appropriations and to the President’s FY 12 request. Under the Senate Appropriation Committee’s approach, the restoring of $285 million in cuts means that the major product review centers, including CDER, CDRH, and CBER, will not sustain significant cuts, as was proposed by the House. Further, the Senate allocated the $50 million increase to implementation of the Food Safety Modernization Act (CFSAN) and to pay increased rents that would otherwise come out of each centers’ budget. Funding for the other Centers and the Office of the Commissioner would be held at the same level as FY 11. The Senate also directs $19 million to be spent on FDA’s efforts to advance medical countermeasures against bioterrorism. These would not be additional funds, but rather FDA would need to find the monies from administrative savings that FDA proposed in the President’s FY 12 request (i.e. ways that FDA thought it could spend monies more efficiently in the new fiscal year). There are a number of additional requests and directions in the committee’s report, which is attached. The bill language is also attached.
  • Prospects for Senate Action and House-Senate Conference on FDA Appropriations: The Agriculture-FDA appropriations bill is considered less controversial than many other appropriations bills. Its fate in the Senate is likely to turn on larger issues of appropriations strategy. If Congress wants some appropriations bills enacted before the new fiscal year starts on October 1, then the Senate is likely to take up the agriculture-FDA bill in September and a (formal or informal) House-Senate conference is possible over the next few weeks. However, there is a persistent rumor that no appropriations bills will be completed this month. If true, this would mean that the entire government would start the new fiscal year funded by a Continuing Resolution. At this point, it is impossible to determine what FDA’s funding level (really the agency’s “spend rate”) would be under a 30-, 60-, or 90-day CR. As we have experienced over the last few years, CRs can be funded using any number of algorithms (e.g., FY 11, the lesser of the House and Senate bills, etc.). Another possibility is that the Continuing Resolution bill might also contain additional titles that are the full/final text of House-Senate agreements on certain appropriations bills. If so, agriculture-FDA might be one of those bills. Whether, sooner or later, the House and Senate will need to reconcile the enormous gap ($335 million) in their proposals for FDA. The House position was formulated using a much lower government-wide aggregate spending level than the final level adopted in the Budget Control Act and used by the Senate. Thus, the House will have room to spend more on FDA. The Alliance will be focused on encouraging the House to agree with the Senate and provide FDA with increased funding above the FY 11 level.
  • Alliance Meetings with FDA Center Directors: Next week the Alliance is meeting with Senior FDA officials to discuss the agency’s resource needs. Meetings are scheduled with FDA’s Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) and Karen Midthun, Director, Center for Biologics Evaluation and Research (CBER).

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