The Alliance Sets It's "Ask" for FY 18

Every year, the Alliance looks at FDA’s appropriated funding needs and establishes how much we will ask Congress to provide to the agency. When we first started a decade ago, FDA budget authority appropriation was $1.5 billion. Every function of FDA was massively underfunded relative to what was needed to carry out the agency’s responsibilities. The situation was so bad that the FDA Commissioner’s Science Board issued a report documenting the agency’s need and made clear that the FDA’s science and mission were at risk because of the extent of underfunding.

Since then, there has never been a year in which appropriators weren’t straining to fit the nation’s domestic discretionary programs into a very limited budget. Nonetheless, the Alliance, as a representative of the FDA stakeholder community (consumers, patients, health professional societies, and industry), has been successful in asking for significant increases and many years we have gotten them. In other years, we have been able to help FDA gain small increases, even while other agencies were flat-funded or cut.It’s important to recognize that the FDA of 2006 did not stand still while more money was being found. The Congress has enacted a half dozen major laws for FDA to implement, science has grown increasingly complex (requiring more FDA expertise), all FDA-regulated products have become more global (requiring FDA to have an international presence), and the regulated industries have become larger (increasing FDA’s workload). So, while the budget authority appropriation has grown from a time of dire need, so too has the funding the agency needs to carry out its responsibilities.Every year, when the Alliance formulates its “ask,” we are put in the position of gauging how much additional funding FDA needs and what, reasonably, the appropriation process is likely to provide. It means that we usually aren’t asking for all the monies necessary to make FDA “whole” relative to its responsibilities. In most years, that number would significantly exceed what we could credibly ask for.This year, the Alliance’s Board of Director’s had an extended discussion of FDA’s needs and how that fits into the current budget environment. We know that there will be strong and continued downward pressure on non-defense discretionary spending, starting with the remainder of FY 17 and going into the FY 18 funding cycle. At the same time, we know that just a few months ago, in the 21st Century Cures legislation, the Congress expressed its continued support of FDA and gave the agency even more responsibility.At the conclusion of the discussion, the Alliance Board decided upon a FY 18 ask of $2.8 billion. This is about $78 million (3%) over the base FY 16 funding (so far, FY 17 is set at the same level under the CR). While this is not everything we could have asked for and not everything FDA needs, this level of funding would significantly contribute to FDA meeting its responsibilities in FY 18. In addition to the $2.8 billion, we will also be advocating for the $60 million in off-budget funding for specific provisions of the Cures legislation. The Cures monies are not available for implementation of the rest of the Cures legislation or for other continued and growing needs of the agency in fulfilling its mission and responsibilities.Join us in sending a coordinated and consistent message to the Administration and Congress that FDA is a unique and uniquely important agency whose mission -- safe foods and safe and effective medical products -- align with core responsibilities of a national government and benefit all Americans every day.

Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.