Commissioner Hamburg Presents to Alliance Quarterly Membership Meeting and more

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.

  • Commissioner Hamburg Presents to Alliance Quarterly Membership Meeting. The Alliance held its quarterly member meeting on Tuesday and we were honored to have Dr. Hamburg as our guest. Alliance President Margaret Anderson interviewed her for about 40 minutes and our member’s questions filled the remainder of the hour.

    • Dr. Hamburg described the key points she makes when trying to tell FDA’s story. She emphasizing that FDA receives only about $8.25 per American per year to oversee nearly a quarter of all consumer spending and set the global standards that are important to the American economy. Not only are the responsibilities large, but she noted that FDA is not given enough credit (even by other federal agencies) for being a science-based organization that is data driven. The complexity of the agency’s job and the impact of globalization are similarly under-appreciated. Given the difficult funding environment, she is very concerned that the agency not become spread so thin that it can’t perform its tasks well.

    • With regard to budgets, Dr. Hamburg spoke optimistically about the FY 13 appropriations process, saying she felt there was support for the small increase in the President’s budget request. With regard to both the FY 14 budget request (in early stages of development) and the potential for an across-the-board cut in FY 13 appropriations (via the sequester), she talked about the FDA’s need to prioritize core functions and that FDA might need to delay other responsibilities that were important but not as great a priority.

    • Separately, she acknowledged that food would be under the greatest pressure in the case of a sequester because it receives only limited user fees to supplement its appropriation. As an example of ways that FDA will prioritize and preserve resources, she described how FDA is implementing the Food Safety Modernization Act by consciously choosing which programs will be implemented sooner and which ones will have to wait for sufficient resources.

  • User Fee Reauthorization Legislation Advances. The House Energy and Commerce Committee approved its bipartisan version of the user fee reauthorization legislation on Thursday. While there are still several outstanding issues to be resolved, the House expects to bring the bill to the floor in May; conference with the Senate in June; and deliver a bill to the President before the July 4th recess. Meantime, the Senate HELP committee voted on its version of the legislation in late April and a floor vote may come as early as Monday. As with the House, the Senate staff are working out some final issues, but the bill enjoys bipartisan support.

    • The Alliance has been tracking this legislation closely because there are a number of new requirements in these bills that are likely to require resources and are not covered by user fees. This was a point also made by the Commissioner in her Q&A: that while FDA supports many of the new responsibilities, it has no assurance that the appropriations committee will supply additional funding to cover them.

  • “Reconciliation in lieu of Sequester” Passes the House. Adopting this legislation is part of the House’s positioning for the post-election session, when Congress will have to simultaneously deal with FY 13 appropriations, deficit reduction via the legally-mandated sequester, and whether and to what extent to renew expiring tax cuts. The Senate is not expected to vote directly on this legislation, although it is possible that Republicans in the Senate may try to add the text as an amendment to another bill. This topic is covered erlsewhere on this web site in today's Analysis and Commentary.

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Preliminary Positioning and the 2013 Budget Cuts: The FDA Should Remain an Exception

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Why Commissioner Hamburg is Already Talking About the FY 14 Budget