FDA Faces Critical Juncture with FY 2010 Appropriations
On Thursday afternoon, June 11, the House Appropriations Subcommittee on Agriculture will have a mark-up that includes FDA appropriations for FY 2010 (starts October 1, 2009). This mark-up, and the one that will follow in the Senate, will be critical events in the capabilities and effectiveness of FDA for the next 5 to 10 years.
After years of drought for FDA, Congress has invested substantial new monies in the agency in FY 08 and FY 09. There are a number of reasons: strong Congressional champions, widespread media coverage of FDA problems, and the education and lobbying efforts of the Alliance for a Stronger FDA.
President Obama has started the FY 10 cycle with a request for a $295M increase for FDA. Given the long, bipartisan history of miniscule presidential requests for FDA, this was an important break with the past. While supporting the President's request, the Alliance is advocating for about $100M more.
Thursday's mark-up is the first time we will see how Congress intends to respond to the President's request. In addition, the mark-up may provide insight into the appropriations committee's view of new legislation that may give FDA significant new responsibilities in 2009.
Tobacco legislation—likely to pass the Senate this week—will be funded by user fees. After that, Congress is likely to pass a major expansion of food safety inspection capacity. Commissioner Hamburg has already stated that the agency does not have the resources to implement the House bill unless it receives new monies. Reimportation of drugs and follow-on biologics are less likely to be adopted than food safety, but are genuine possibilities this year. Each will be expensive.
The risk is that the gains of the last two years and another $300M for FY 10 will wind up paying for new responsibilities, rather than strengthening the agency. Hopefully, Chair Rosa DeLauro (D-CT) will reference these additional needs in her opening remarks. Or there might be committee language acknowledging the need for additional funds if Congress passes new laws that give FDA more responsibility.
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For those not familiar with the Alliance for a Stronger FDA, its 180 members represent the full range of agency stakeholders. They are strong advocates for increased appropriations for FDA and united in the belief that "a stronger FDA benefits everyone."
In the interest of full disclosure, I was one of the founders of a predecessor organization and now serve as deputy executive director of the Alliance. FDA Matters is not affiliated in any way with the Alliance.
The more members the Alliance has, the stronger its voice on Capitol Hill and in the media. If you want more information about the Alliance, write me at: sgrossman@strengthenFDA.org.