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Of Smoke, Mirrors, and Advocacy Participation

February 12, 2016

The headline reads: the President proposes $5.1 billion, an 8% increase for FDA. The reality is that only a $15 million increase is proposed for appropriated funding, about half of 1 percent above the FY 16 level. The claim of 8% can only be realized by including user fee increases (inflation adjustments) and proposed new user fees (many of which have no chance of enactment).

Worse than this perceptual gap is an actual gap: a major disconnect between the budget narrative provided by the President (“Congressional Justification”) and the funds proposed to carry out the FDA’s responsibilities in FY 17. If you read the program description and plans for FY 17, you would expect the agency to receive substantial additional funds. Then you look at the actual numbers and worry whether the agency is being set up for failure with the small increase proposed. For example, FDA’s food safety program needs $150 million or more to continue full implementation of the Food Safety Modernization Act, but only $26 million is proposed.

Apart from food, the rest of the agency is level funded, with a few budget lines that dip below the FY 16 base. Dr. Woodcock’s admission that the biosimilars program is not staffed for a coming deluge of applications (see here) raises the question of how this can be remedied if the Administration proposes that CDER be level-funded.

How dire is the situation? If the President’s recommended funding is adopted, FDA will need to choose among the numerous public health priorities. Some things that must be done by FDA, won’t get done.

As advocates, our job is to quickly move to the next step: galvanize Congressional action to add money for FDA. We hear variously that the Obama budget is dead on arrival on the Hill or that Congress will set its own priorities. This may be true, but the realities are still: the President’s request is the baseline against which all funding decisions are compared and there are no easy pockets of money available to supplement FDA’s budget.

This challenge starts with you. Participate in our Hill Days. Let Ladd know if you are available for Hill meetings apart from Hill Days. Add FDA funding into your advocacy materials so that Members of Congress can see how important it is to fund FDA. Last, but not least, help us recruit new members — a key to our success continues to be the recognition that all FDA stakeholders are part of the Alliance and that they all share its goal of increased appropriated funds.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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