FAQ about FDA Funding for Fiscal Year 2023

Q: What happens to FDA funding if there is Continuing Resolution (CR) starting October 1?
A: If there is a FY 23 CR, FDA will likely have only the amount to spend that it did in FY 22 and cannot undertake certain new initiatives. Because Congress is considering boosting FDA’s budget authority (BA) appropriation by $341 million (House-passed) or $229 million (Senate-draft), there is a substantial gap between Congressional perception of FDA’s needs in FY 23 and the money FDA will have available to spend under a CR.

Q: Can a CR run for the entire year, limiting the amounts of monies available to federal agencies, including FDA?
A: Yes, and it has happened. This might come about if agreement on a topline number for Federal discretionary spending continues to be elusive. The relative balance between defense and non-defense spending can also be a roadblock. Usually, there would be multiple CRs while Congress continues to work on a spending package before a decision is made that a full-year CR is unavoidable.

As difficult as it can be for Congress to negotiate a budget compromise, it is most likely that FY 23 funding bills will eventually be adopted. While there are several reasons, the most powerful is that the Defense Department has difficulties operating under a CR and is severely constrained under a full-year CR. Just like DOD, FDA needs appropriated increases to sustain its growing responsibilities.

Q: Why is there an impasse in user fee negotiations?
A: The House-passed and the Senate HELP Committee-passed bills both include non-user fee provisions, a substantial number of which are not the same in both bills. Since the user fee reauthorizations should pass before they lapse on October 1, there is a prevalent view within Congress that House-Senate conferees can work quickly to resolve the differences. There is a dissenting view that the best option is to pass clean user-fee reauthorizations and to address the non-user fee provisions separately and later.

As noted in Advocacy at a Glance (above), there are no reports of negotiations to break the impasse. However, all the Representatives and Senators involved in these negotiations understand the need for timely action. It is hard to imagine Congress returning to DC in September without having achieved a preliminary agreement on a path forward. As Dr. Woodcock has noted: the impasse is already affecting morale and recruitment.

Q: In addition to the transcript of Dr. Woodcock’s webinar, where else can I find information about the FDA’s technology modernization needs?
A: Over the last 3 years, FDA has developed and issued three plans for modernization of FDA’s infrastructure. the 2019 Technology Modernization Action Plan (here); the 2021 Data Modernization Action Plan (here); and the 2022 Enterprise Modernization Action Plan (here) Meantime, FDA has allocated part of its Budget Requests to fund this need (page 13 (here); the Alliance’s testimony to the appropriations committees has included a request for funding (House and Senate); and Congress has indicated interest in infrastructure modernization at FDA (here).

Editorial Note: This week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.