Legislative status: FY 22 appropriations and FY 23 appropriations; No Senate vote yet on Dr. Califf
Top-Line:
Analysis and Commentary - this week’s Alliance webinar on “How FDA Is Funded”
Legislative Status: FY 22 Appropriations.
Legislative Status: FY 23 Appropriations.
No Senate vote scheduled yet for Dr. Califf.
Webinars completed and more are planned.
This week’s Analysis and Commentary summarizes this week’s Alliance webinar on “How FDA Is Funded.”
Legislative Status: FY 22 Appropriations. The Chairs and Ranking Members of the House and Senate Appropriations Committees — and their staff —continue talking amid signs of progress during the past week. Critical to a final pact is agreement on total FY 22 spending, the defense/non-defense ratio, and levels of spending by subcommittee (302(b) allocations). Part of the impetus pushing the negotiations along — rather than stalling because of disagreements — is difficulties that the Department of Defense would face if a full-year Continuing Resolution were adopted.
With the current CR expiring on February 18 (two weeks from today), there is likely to be a further short-term CR. If not, there would be a shutdown. However, shutdowns usually result from willfulness on the part of the President or some member of the House and Senate. This time, at least, everyone seems to agree a shutdown would be bad. That recognition will generate support for a short-term CR in the likely event appropriations bills are not ready at the end of the CR.
A further wrinkle: there are now hints of bipartisan support for a full appropriations bill for defense (because of geo-political events) and a short-term CR for the remainder of government. We assume that Democrats would not agree to that without an ironclad agreement that non-defense spending will not be disadvantaged by this arrangement.
Legislative Status: FY 23 Appropriations. The earliest likely date for the President’s FY23 budget request is about 10 days after the State of the Union (SOTU), which is scheduled for March 1. It could also be released later. This week, there was some indication that the Biden Administration plans to come close to the 10-day spacing. This would put the budget release during the week of March 7 or March 14.
No Senate Vote Scheduled Yet for Dr. Califf. We are told that Senate Majority Leader Schumer will schedule a vote as soon as he is sure he has enough votes to confirm Dr. Califf. Reflecting the Alliance’s concerns about the institutional aspect of being without a permanent FDA Commissioner, the Alliance released the following statement:
"In the current environment, it's hard to overstate the importance of Senate-confirmed leadership at the FDA. We implore the Senate to move with urgency and confirm a new FDA Commissioner."
For those interested in an historical perspective: Nine FDA Commissioners having been confirmed since the first confirmation in 1990. When there have been extended delays in the past, those delays primarily occurred between the creation of the vacancy and the nomination of the next Commissioner, not between the nomination and confirmation. Dr. Califf is still within the 2-to-4-month window that it usually takes between nomination and confirmation.
Webinars Completed, More Webinars Planned. So far this year, the Alliance has held a webinar with Acting FDA Chief Scientist Jacqueline O’Shaughnessy and another this week on “How FDA Is Funded.” The latter is summarized in this week’s Analysis and Commentary (below), the transcript is here, and the slides accompanying the presentation are here. We expect a transcript of Dr. O’Shaughnessy’s remarks to be available next week.
The Alliance is planning many additional webinars this year. In next week’s Friday Update, we will be announcing a series of webinars with the FDA Center Directors and the Associate Commissioner for Regulatory Affairs. We look forward to seeing you at them. As always, all the details will be in Friday Update.