Broad Outlines of the Budget Deal
This week’s Analysis and Commentary provides first impressions of the budget deal and its possible effects on FDA funding. The pivotal point: macro-budget decisions (e.g. spending caps) limit but do not determine micro-budget decisions (e.g. how much is available to fund FDA).
Broad Outlines of the Budget Deal. The House on Wednesday, May 31 by a vote of 314 to 177 passed HR 3746, the Fiscal Responsibility Act of 2023 (FRA). The Senate approved the bill by a vote of 63-36 on Thursday, June 1. The President is expected to sign the measure into law. This agreement, negotiated between the House of Representatives and the White House, suspends the debt limit through January 1, 2025 and establishes topline spending limits for both FY 2024 and FY 2025. These spending limits, discussed in today’s Analysis and Commentary, are stringent limits that will increase the challenge of growing FDA’s budget to fit its expanding responsibilities.
After the Budget Deal, What Next? The FRA’s spending caps will be translated into aggregate spending authority available to the House and Senate Appropriation committees (this occurs pursuant to section 302(a) of the Budget Act). Those amounts are then further divided into allotments for each subcommittee, pursuant to section 302(b) of the Budget Act.
FDA and a number of other agencies must all fit within the 302(b) funds made available to the House and Senate Subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. The timing of each of these steps should emerge once the legislation becomes law.
The full committee markup of the House Agriculture/FDA Appropriations bill (passed by the subcommittee in May) has not yet been rescheduled. While the Senate Appropriations Committee leadership has said they want to mark up bills in June, they have yet to announce any dates for action.
June Alliance Webinars are Now Scheduled; Registration is Open. Our June webinars will focus on two timely topics: FDA staffing and the Oncology Center of Excellence.
FDA Chief of Staff Julie Tierney: Comprehensive Overview of FDA Staffing.
This year’s 10 Alliance webinars with senior FDA officials produced myriad questions about vacancies, hiring incentives, recruitment, retention, training, “back to campus” policies, pay scales, and more. To provide a comprehensive overview of FDA staffing, Julie Tierney, the FDA’s Chief of Staff, will be the featured speaker at this Alliance webinar. Join us on Monday, June 5 at 1:00 PM by registering here.
FDA Oncology Deputy Director Paul Kluetz: Update on Progress at OCE.
The Oncology Center of Excellence (OCE) was established in 2017 to unite experts across the FDA to conduct expedited reviews of medical products for oncologic and hematologic malignancies. Dr. Paul Kluetz, Deputy Director of the OCE, will update us on the OCE–structure, resources, and advances. Join us on Tuesday, June 20th at 3:30 PM by registering here.
FDA Science Forum: June 13/14 on Advancing Regulatory Science Through Innovation. This is one of FDA’s signature events for the sharing of insights from FDA’s research and regulatory science programs. Register here and here.
Among the topics to be addressed are: 1/ improving clinical and post-market evaluation; 2/ empowering patients and consumers; 3/ advancing products based on novel technologies; 4/ food and cosmetic safety; 5/tools to effectively use big data; 6/ product development and manufacturing; 7/ medical countermeasures, infectious disease, and pathogen reduction technologies; and 8/ substance use, misuse, and addiction.