Q&A About FDA and the FY 24 Budget/Appropriations Process
Q: What will the Alliance be telling Hill staff in meetings over the next two weeks (and beyond)?
A: We support the Administration’s request for $3.914 billion in BA funding for FDA in FY 24.
FDA has a uniquely difficult mission while providing a core function of government
FDA needs more resources each year because of its expanding mission and growing responsibilities
FDA’s mission and responsibilities are incredibly consequential and visible
Q: House Appropriations Chair Kay Granger announced her goal for mark-ups in May and floor action in June. What happens next?
A: Chair Granger’s schedule is possible, maybe even likely.
The key is whether there is an agreement among House Republicans on: 1/ aggregate FY 24 spending, 2/ the split between defense and non-defense spending levels, and 3/ which parts of the government will be protected from cuts.
If so, the Chair will need committee approval of a 302(b) allocation–setting the amount that each subcommittee can spend. Bills can then be pushed through subcommittee and committee on party line votes.
House Speaker Kevin McCarthy is working on a legislative package that would set House aggregate spending levels. The defense/non-defense splits and the protected programs are not covered in the bill but can be negotiated within the Appropriations Committee and with Speaker McCarthy and the Republican Caucus.
The Speaker’s legislation is tied to the must-pass debt limit extension–and he is hoping for a vote next week or the first week in May. While he will be heading for a showdown on the bill with the White House and the Senate, the House Appropriations Committee mark-ups could proceed. His negotiating position is enhanced if there are House-passed spending bills that he can point to.
Q: As Congress starts appropriations hearings and looks at possible mark-up dates, there are references to the President’s Request (a 10% increase for FDA) as being “dead on arrival.” Is that true?
A: No, it is not DOA. The President’s request is a blueprint for defining funding needs, especially at the program and line item levels. Further, when the subcommittees mark-up their bills, the President’s numbers are a column in every table and a point of reference as to where the committee’s priorities align or diverge from the Administration’s.
We may not get what the Administration asked for, but the funding levels and priorities are still of ongoing importance.
Q: An analysis appeared this week claiming that only nine of FDA’s 22 most senior leaders were in their current positions three years ago and two of them (Drs. Mayne and McMeekin) are retiring. What is reasonable turnover?
A: I am a big fan of the analyst who put this together. However, it doesn’t give an accurate portrayal of leadership turnover. Dr. Cavazzoni should count–she has been acting and then director of CDER for more than three years. Dr. Woodcock should count–she is still in a senior position (albeit not the one she held three years ago).
Most (not all) of the remaining 11 positions are ones that turn over about every 2 to 4 years with changes in the presidency (January 2021) and/or the Commissioner (February 2022), both of which occurred less than 3 years ago.
The two pending retirements are not short-timers. Dr. McMeekin joined FDA in 2007; Dr. Mayne joined FDA in 2015. Both had long careers prior to joining FDA.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.