How Likely Is a Shutdown?
The Alliance is a resource to the entire FDA stakeholder community. We welcome your questions about FDA and what may happen should there be a government shutdown (send questions to sgrossman@strengthenfda.org).
This week’s Analysis and Commentary starts that process by addressing some of the most frequently asked questions about FDA and a government shutdown.
How Likely Is a Shutdown? The Senate plans to spend in accordance with the budget limits in the Fiscal Responsibility Act of 2023, passed earlier this year. Accordingly, the Senate Appropriations Committee has approved 12 bipartisan appropriations bills and they are being bundled into minibusses for floor consideration in mid-September. Ag/FDA is expected to be in the first minibus bill, which will also include: 1/ Military Construction, Veterans Affairs, and Related Agencies; and 2/ Transportation, Housing, and Urban Development. Senate floor consideration is likely to be late next week or early the week of September 18.
A Continuing Resolution (CR) will be needed to fund the federal government beginning October 1 and the Senate is hoping to add additional disaster relief funds and additional military support for Ukraine, as requested by President Biden and widely supported in the Senate.
The House is also moving funding bills to the floor in September, but the tone and intent are quite different. Their appropriations bills were passed in party-line votes and are based on spending considerably less money in FY 24 than the Fiscal Responsibility Act of 2023 intended. Beyond that, there is a contingent of House Republicans who have said they won’t vote for a CR without considerable concessions from the Senate and President. They also appear to be against additional funds for the Ukraine war.
It is hard to see how this will be resolved–and a CR adopted–before the fiscal year ends on September 30. However, it is in the nature of these kinds of disagreements that solutions are eventually found and the timing is impossible to predict in advance.
The Alliance has started to update materials that we have used to inform stakeholders and media during prior shutdowns and shutdown threats. To start this process, this week’s Analysis and Commentary answers the most frequently asked questions we are getting about FDA and government shutdowns. Send any further questions to sgrossman@strengthenfda.org.
Prospects for Government Funding Via a Continuing Resolution. With only three weeks remaining before the new federal fiscal year begins, it is a virtual certainty that the government will operate under a Continuing Resolution (CR). The length of this CR and what anomalies, i.e., special provisions, will be included is yet to be determined. The Administration’s requested anomalies can be found here, but do not impact FDA.
Both Senate Majority Leader Schumer and Minority Leader McConnell have called for bipartisanship to keep the government open, but House conservatives continue to insist that any CR should strengthen border measures, end a controversial Pentagon abortion policy, and block the Justice Department’s efforts to prosecute Donald Trump.
Ag/FDA Appropriations: Review of House and Senate Positions. In June, the full House Appropriations Committee favorably reported the FY 24 Ag/FDA funding bill (HR 4368) on a party-line vote of 34 to 27. The Committee provided FDA with $3.504 billion for budget authority (BA) funding, close to what it received in FY 23. For more background from the Alliance: House Appropriations Committee Advances FY 24 Ag/FDA Bill and our commentary Q&A on House Appropriations Markup.
Later in June, the full Senate Appropriations Committee unanimously reported S. 2131, the FY 2024 Agriculture/FDA Appropriations bill. The measure included $3.55 billion for FDA, an increase of $20 million over the $3.53 billion provided by the House measure. The FDA portions of Senate Report 118-44 can be found here. For more background from the Alliance: Senate Appropriations Committee Approves $20 million Increase for FDA and our commentary Q&A on Senate Appropriations Mark-up.
Upcoming Webinar on FDA and AI.
Our guest: FDA’s Acting Assistant Director of Digital Health Policy MiRa Jacobs, Ph.D.
September 19 from 11 to noon. Please register here!
Artificial intelligence and machine learning (AI/ML) are profoundly impacting health care, food safety, and medical product development and manufacturing. More is coming. FDA’s Digital Health Center of Excellence is at the center of conversations to ensure innovations in this space serve to assist FDA and benefit the American public.
We have asked Dr. Jacobs, FDA’s Acting Assistant Director of Digital Health Policy, to discuss the integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.
Also of relevance, Senator Cassidy (R-LA), in his capacity as the Ranking Member of the Senate HELP Committee, is circulating a white paper, entitled Exploring Congress’ Framework for the Future of AI.