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Much Achieved … and Much to Be Done

December 18, 2009

ANALYSIS AND COMMENTARY

Three and a half years ago, two separate groups decided that FDA needed a friend, one who would advocate for more resources to strengthen the agency. Two years ago, those organizations merged to form the Alliance for a Stronger FDA. Together, we have grown to nearly 200 members and can point to remarkable success in FY 08, 09 and 10.  The bottom line: FDA’s appropriated budget has grown by 50% over those three years.

We have much to be proud of. We have much to be thankful for. We have much work to do if FDA is to enjoy similar success in the FY 11 budget cycle.

Three powerful forces will be arrayed against the agency in the coming year. 

We are told that the President’s theme — to be unveiled in the State of the Union address — is that we need to make tough decisions in order to reduce the deficit. Federal departments, such as the Department of Health and Human Services, have been asked to submit FY 11 budgets that reflect flat funding and also an alternative budget with a 5% overall decrease.  Secretary Sebelius has been asked to choose her priorities, knowing that requesting more money for one agency means that there will be less money for another.

Keep in mind, also, that a flat budget is not break-even. Typically, agencies have to absorb increased pay and benefit costs. Since FDA’s budget is almost all “people costs,” it will take a $120M increase in FY 11 funding to avoid program cutbacks.

Second, the Congress has been busy working on new authorizing legislation that mandates actions by FDA. Tobacco is self-supported by user fees. However, if either follow-on biologics or food safety legislation becomes law, then FDA will have new tasks requiring new monies. Otherwise, the agency will be shifting resources at the expense of some other important part of its public health mission. There is some lag time before some of the new authorities would go into effect, but the crunch would start in FY 11 and get worse for at least the three following fiscal years. “Break-even” for FDA is then a $120 million increase, plus costs of implementing new legislation and new responsibilities.

Third, in a tough budget year, Congress often decides that agencies with fast-growing budgets should take a year off — to make full and best use of the monies that they have already received. Since FDA is still severely underfunded, we believe that it would be unwise to interrupt FDA’s momentum. Whether the President takes this position, we are sure to hear this argument in the appropriations debates next year.

So, we expect 2010 to be difficult. To help our cause, we will have new materials for the Hill, a new website, and step up our efforts to enlist media and grassroots. Our metrics project — designed to show that new monies are being spent appropriately by FDA to fulfill its mission — should be ready by the Spring.  More than anything, we need the Alliance members to continue to be active in our common cause. New members are particularly welcome as we look to add 50 or more members by mid-year.

Our voice will be quiet for the next two weeks, but the needs of FDA are never far from our minds.

Have a relaxing holiday and a happy and health new year. We count on your support in 2010.

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

MEDIA/NEWS

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