Alliance Seeks $2.85 Billion for FDA for FY 17

We have said that the President’s FY 17 budget request for FDA is “disappointing” and “alarming” because it proposes only a $15 million increase over the agency’s FY 16 budget authority (BA) appropriations. Simply, FDA’s needs will be greater in FY 17 than FY 16 -- and by more than $15 million. If FDA doesn’t receive more than the President’s request, the agency will have to choose among competing public health priorities. The consequences will be felt by the American people, as well as the regulated industries.After having an opportunity to review the President’s proposed budget, the Alliance is recommending that FDA’s BA appropriation grow by $120 million. This would take the agency from the FY 16 funding level of $2.73 billion to a proposed $2.85 billion for FY 17.

Our rationale is that FDA’s broad and far-reaching responsibilities continue to expand annually. The agency’s larger needs emanate from legislative requirements, increased complexity of science, globalization and homeland security activities (which includes the Ebola and Zika viruses). Specifically, the Alliance’s proposed funds will be used to: (1/ carry out a number of medical product initiatives, such as biosimilars, drug compounding, and regulatory science (e.g., validating biomarkers, post-market surveillance) and (2) incrementally fund implementation of food safety activities. Also, FDA needs the tools, including effective planning, to continue to manage its growing responsibilities.In addition to this request, we support the $75 million transfer of funds to FDA from NIH under the Administration’s legislative proposal to fund a “cancer moonshot” initiative. If the proposal is adopted and the monies transferred, they would be used to create an oncology center of excellence at FDA. Since these funds are in the President’s proposed NIH budget, we are not counting them as part of the FDA request.

Please include the Alliance’s ask in your communications with Congress. Please join our activities educating Congress about the FDA and its resource needs.In the current budget environment, it is not easy to be an advocate for spending -- but priorities need to be set within the nation’s budget, rather than making all programs chronically underfunded. We look forward to working with the appropriations committees this year as they work to evaluate and determine national priorities. As part of that review, we will be asking that the FDA be given special consideration for the important work it does.

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