FY 22 appropriations: breakthrough agreement but few details; Another CR through March 11.
Top-Line:
Analysis and Commentary – Impact of the FY 22 and FY 23 Appropriations Cycle on FDA; the Alliance’s view on commissioner vacancies.
FY 22 Appropriations: Breakthrough agreement but few details; another CR through March 11.
Legislative Status: FY 23 Appropriations.
Senate may vote soon on Califf nomination.
Webinars completed, webinar series on FDA’s FY 23 budget priorities announced:
This week’s Analysis and Commentary is devoted to Q&A about: 1/ the impact on FDA of the FY 22 and FY 23 appropriations cycle, and 2/ about the history of vacancies between Senate-confirmed FDA Commissioners and the Alliance’s views on this.
FY 22 Appropriations: Breakthrough Agreement but Few Details. This week, the Chairs and Ranking Members of the House and Senate Appropriations Committees announced agreement on a framework for finishing the FY 22 appropriations process. Details were not announced, but reportedly the agreement was encompassing enough that Appropriations Committee staff were told they can begin drafting bills.
Media reports suggest there was an agreement to increase defense spending by as much as non-defense spending, whereas the President’s request and the House-passed bill envisioned larger increases for non-defense spending. Policy riders from existing law would continue unless all parties agree to strike or amend them. Beyond that speculation, there is little certainty about what was agreed upon and a sense that many issues still need to be negotiated.
FY 22 Appropriations: Another CR Would Extend Through March 11. The current Continuing Resolution expires on February 18, nowhere near enough time to pass appropriations bills. Accordingly, the House has passed a further CR that would extend government funding until March 11 (three weeks from February 18, a month from today). The Senate is expected to consider the CR extension next week.
There is widespread and bipartisan support for the CR extension, hence no expectation of a government shutdown. However, as with nearly any must-pass legislation in the Senate, there is always room for side issues to threaten orderly passage (WP story on alleged government support for distributing crack pipes).
Legislative Status: FY 23 Appropriations. The President has scheduled his State of the Union (SOTU) for March 1. Typically, the President’s Budget Request is released within two weeks afterward. Last week, there were some indications that the Biden Administration plans to stick with that, suggesting the budget could be released during the week of March 7 or March 14. Some slippage is certainly possible.
Senate May Vote Soon on Califf Nomination. Senate Majority Leader Schumer has started the process for invoking cloture (imposing time agreements on debate) on Dr. Califf’s nomination. That suggests a vote might come as early as next week.
Presumably, Senator Schumer would not schedule a vote without certainty that he has at least fifty votes (with VP Harris available to vote if there is a tie). This would represent a surprisingly quick turn-around since it appeared that Dr. Califf was still short of the needed votes earlier this week. Through media reports, we understand that Dr. Califf picked up Senator Warren’s vote last week based on agreeing to an expansive set of post-employment restrictions. This week, the media reported that Senator Wyden received a commitment that Dr. Califf would review the accelerated approval process.
Dr. Califf’s nomination is discussed further in this week’s Analysis and Commentary.
Webinars Completed, More Webinars Planned. So far this year, the Alliance has held a webinar with Acting FDA Chief Scientist Jacqueline O’Shaughnessy (summary, transcript) and on the topic “How FDA Is Funded” (summary, slides, transcript). The O’Shaughnessy transcript is newly available this week.
The Alliance is planning additional webinars this year (see next story). Those will be announced in Friday Update, and we will supplement this with additional notices. These online events are for Alliance members and media, although we welcome guests. If you are not a member and would like to participate, please contact Alliance Executive Director Steven Grossman
Alliance Announces Webinar Series on FDA’s FY 23 Budget Priories. Starting April 4, we will hear from FDA’s Center Directors and the Associate Commissioner for Regulatory Affairs on the agency’s budget priorities, as follows:
Patrizia Cavazzoni, MD CDER April 4, 1 p.m. Register
Judith McMeekin ORA April 6, 2 p.m. Register
Susan Mayne, PhD CFSAN April 12, 11 a.m. Register
Steven Solomon, DVM CVM April 22, 3 p.m. Register
Jeff Shuren, MD CDRH April 29, 11 a.m. Register
We expect to announce a CBER date shortly.