Another Wave Election ... and the Aftermath

November 2 Election Results.  In our weekly column below, we provide a brief analysis of how the elections may impact the FDA’s budget.  In short, we predict a challenging FY2012 Appropriations cycle, but working together we plan to make a strong case for continued investment in the FDA. The public health, economic and homeland security benefits of a strong FDA merits further investment.

FY2011 Appropriations.  Congress will come back into Lame Duck Session the week of November 15.  One of its major tasks will be to determine FY2011 funding beyond the current Continuing Resolution.  The House Appropriations Committee had $55 million above the President’s request and where the Senate Appropriations Committee ended up.  We plan to ask the Senate to recede to the House’s higher number.  Expect a letter from the Alliance to Congressional Leadership next week.  We will then ask our members to help get that message out.  Given the likely challenges for the FY2012 cycle, we need to focus on the best number possible FY2011.

Medical Countermeasure Regulatory Science Initiative.  Last week at the Alliance Annual Meeting, Dr. Luciana Borio spoke to the Alliance on the Medical Countermeasure Regulatory Science Initiative.  This $170 million initiative is as large as the Center for Biologics Evaluation and Review (CBER) at the FDA.  With such a large investment (larger than the increased proposed for the entire FDA by the President for FY2011), we believe this initiative merits close attention and understanding by all Alliance members.  

ANALYSIS AND COMMENTARY

As a result of the 2010 Mid-Term election, Republicans have netted more than 60 seats and taken control of the House of Representatives, effective in early January, 2011.  The Senate will remains in Democratic hands, but with a much slimmer majority.So-called “wave elections,” where one party overwhelms the other, are particularly hard to judge because the ground rules are going to change dramatically, but no one knows in what ways. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months or become clear before the new Congress arrives.We do know a few important things for which we are fully confident:  

Regardless of how Democrats, Republicans and the President choose to interact in 2011, there will be a working majority in both House and Senate for significant deficit reduction.

  • Both Democrats and Republicans campaigned on a promise of deficit reduction. This is not a good budget environment for FDA or any federal agency with growing responsibilities.

The direction of deficit reduction is yet to be determined.

  • There is a large difference between campaign rhetoric (both parties) and the realities of reducing the deficit.

The situation in both House and Senate is fluid with regard to committee assignments, chairmanships and leadership.

  • Most commentators assume there will be few changes other than the reversal of majority and minority in the House. However, there are many vacancies and one person’s decision could affect the choices available to a dozen other members.

  • In sum, expect changes in the committees that authorize, appropriate and oversee FDA.

The Alliance for a Stronger FDA has been preparing for this much tougher budget environment.

  • The Alliance recognized a year ago that the federal budget situation was likely to deteriorate and has spent the intervening time building the case for FDA to be seen as an exception to budget-cutting.

  • The Alliance plans to continue to argue that the public health benefits of a strong FDA merit additional investment. In addition, we will be rolling out documents to support the economic benefits and the homeland security benefits of a strong FDA.

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

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