Advocating for a Responsibility-based "Ask"

The Alliance’s FY 21 “ask” (here) is based on two themes: growing FDA responsibilities require an FDA budget that grows; and FDA’s vital responsibilities have become more sophisticated and complex, requiring additional resources. Said another way: FDA’s responsibilities have grown both wider and deeper.In considering the agency’s needs, and cognizant of the need to deliver these messages, the Alliance board adopted an “ask” that calls for an increase of $120 million in budget authority (BA) above the FY 20 appropriations level. This would bring FDA “salary and expenses” to $3.278 billion. This would be an overall increase of just under 4% compared to the FY 20 enacted levels and an increase of $72 million over the Administration's FY 21 request. Funding under 21st Century Cures, $70 million, is separate and additional because it is paid out of savings from mandatory programs, rather than being taxpayer funded.The ”ask” was formulated and agreed upon in mid-February. Since then, a lot has happened and FDA’s responsibilities and funding have grown in the interim. As we put the Alliance’s House and Senate testimony together, it became clear that we needed to address the changed perspective.So, we added in the testimony the following summary of the Alliance’s position:No one knows what demands are going to be placed on FDA and other public health agencies over the next 18 months. As a result, our views on FDA’s resource needs are in three parts:The Alliance had previously recommended a $120 million increase for FDA for FY 21. That request covers many needs throughout the agency. Those needs are not any less important because of COVID-19.Beyond that, it is appropriate to consider what else will be needed because of the changed circumstances and the unknown arc of the current pandemic. Accordingly, we ask the Committee to seriously consider making the FY 20 supplemental coronavirus monies part of the FDA’s base funding for the FY 21 funding cycle.Finally, we point to the likely need to fund expanded FDA readiness in FY 21 -- although the specifics and costs are not yet clear. Post-COVID-19, we need to be better prepared for the threats we know, the risks we can foresee, and have the mechanisms in place for those risks that we cannot yet imagine.Stated this way, the request covers the “here and now” needs of the agency, while leaving open the possibility that it could change in the next few months. So much is different from 6 weeks ago that we should not assume they will look the same three months from now.The Alliance will continue to work with the Hill and other advocacy organizations to be sure that FDA’s needs are fully understood by appropriators. While we don’t want to ask for more funding than is needed, the greater risk is that the agency might get less than needed. We are united in saying: that can’t be allowed to happen.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.