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Beyond the Election Campaign

October 9, 2010


Medical Countermeasures and FDA Regulatory Science.  Next week the Alliance is meeting with Dr. Luciana Borio, who is directing the FDA’s new Medical Countermeasures (MCM) initiative. This is an outgrowth of the Secretary’s report on HHS’s involvement in national security that was released in August. The initiative will also contribute to FDA’s efforts to strengthen regulatory science at the agency.

Yesterday, and unrelated, FDA issued a report on the subject of regulatory science entitled “Advancing Regulatory Science for Public Health, A Framework for FDA’s Regulatory Science Initiative.”

Alliance Board/Annual Membership Meetings

  • Board Meeting: Thursday, October 14 at 2:00 pm
  • Annual Member Meeting: Wednesday, October 27th at 2:00 pm


Based on the campaign strategies of both parties, the tone and tenor of the next Congress is foreseeable. Even the likely impact of the election on President Obama’s policies seems fairly clear. It is an environment in which FDA is going to struggle, but there will be opportunities to increase the resources available to the agency.

I don’t know how many Republicans or Democrats will be elected to either the House or Senate. And beyond the large number of shoe-ins, there seem to be a very large number of races that are too close to call. Even if FDA’s champions are re-elected, we don’t know if they will hold the same positions next year. For example, five of the 12 Republicans on the Senate Appropriations Committee are retiring, running for another office or lost their primaries. Depending on the outcome in the Alaska Senate race, it may be half of the Republicans on the committee who will not return to the Senate. As there will be changes with Senate Republicans, the retirement of House Appropriations Committee chair David Obey will probably create some “musical chairs” among the panel’s top Democrats.

The fate of FDA will be driven by the post-election tone of Congress, at least as much as by individual Members. Looking around the country, nearly every candidate is running “against Washington.” The major themes among Democrats and Republicans alike are the need to create more jobs and the need to reduce the burgeoning government deficit and national debt. Congress may be stymied in the jobs area, since it is unclear how to create more jobs and divergent views about which approach to take,.  

That means Members will be working extra hard to show the electorate that the deficit is being tamed. This year’s level funding of all government agencies in the first continuing resolution has to be seen as a placeholder for more severe cutting that might occur later this year or early in the next Congress. Regardless of the outcome of specific races or which party has the most seats, there will be a working majority of Republicans and Democrats in the House and Senate who are committed to deficit reduction.

President Obama will share philosophy and be working with the deficit-cutters. Disagreements will focus on very specific items or on how far to cut and how fast. When it comes to deficit reduction, the White House clearly sees what the campaigns see: nearly across the political spectrum, voters want the federal government to spend less … or at least dramatically slow the increases that are already built into budget projections.

None of this sounds good for FDA. And it isn’t. A year ago, the Alliance anticipated that increases would be harder to get. Throughout 2010, the Alliance has been building on the theme that FDA needs to be an exception to whatever budget cutting occurs. Our focus has been to show how a well-resourced FDA creates jobs in the American economy. We know this is so, but it is not the easiest thing to prove. We have talked about FDA’s role in our national defense because of its pivotal role in development of medical countermeasures in case of a terrorist attack. We have also focused on the extraordinary demands being placed on the agency, be it growing responsibilities for medical product reviews and food imports or the unexpected items such as pandemic flu and contaminated eggs.

Our goal, regardless of the budget environment, is to keep making the case for FDA “exceptionalism.” No one knows if it will work in 2011 and 2012. We do know that the agency cannot function if it is caught in an “across the board 5% or 10% cut in domestic discretionary spending. A couple of times in the last few years, most federal agencies were level funded and FDA was, nonetheless, given an increase in funding. The agency was on a short list of “exceptions.” The Alliance needs your continued support to make this happen again.  

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



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