Legislative status: FY 22 appropriations and FY 23 appropriations; Digital Health draws more agency attention.
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Analysis and Commentary: a summary of the Alliance webinar with Dr. Jacqueline O’Shaughnessy.
Legislative status: FY 22 appropriations.
Legislative status: FY 23 appropriations.
No Senate vote scheduled yet for Dr. Califf.
FDA publishes Year in Review for 2021.
Digital Health draws more agency attention.
Upcoming Alliance webinar - “How FDA Is Funded” featuring Alliance Board Member Emily Holubowich and Executive Director Steven Grossman on Wednesday, February 2, 2022, at 3 p.m.
Why sign up to learn “How FDA is Funded.”
This week’s Analysis and Commentary (below) provides a summary of the Alliance webinar held this week with Dr. Jacqueline O’Shaughnessy. The transcript will be available soon.
Legislative Status: FY 22 Appropriations. The Chairs and Ranking Members of the House and Senate Appropriations Committees — and their staff — continued talking during this recess week. There are encouraging signs that negotiators are moving closer to an agreement on total FY 22 spending, the defense/non-defense ratio, and levels of spending by subcommittee (302(b) allocations). None of this rumored movement is publicly visible, at least yet, and it is hard to determine what additional roadblocks may arise. Further, the two sides must agree on a multitude of legislative riders—many of which involve hot-button issues and will be hard to reconcile.
The overall situation is still grim, even with rumors of progress in negotiations. 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. The Pentagon has pressed its case on the Hill and there does seem to be an emerging consensus on the need for increased defense spending. The current geopolitical tensions with Russia undoubtedly make the case even stronger.
Since Democrats will not support moving defense and non-defense funding separately, those who favor increased defense appropriations will have to agree to an omnibus that includes increases in non-defense spending.
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. Despite this late start, Congress must pass funding bills or a CR by October 1. From this we conclude early delays in moving forward on FY 23 appropriations are likely to result in compression rather than an extension of the FY 23 appropriations process.
No Senate Vote Scheduled Yet for Dr. Califf. Dr. Califf’s nomination will be pending when the Senate returns from recess next week. However, a vote has not been scheduled and it is unclear when it will be. 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.
FDA Publishes Year in Review for 2021. FDA has released a summary of its 2021 accomplishments. The report can be found here.
Digital Health Draws More Agency Attention. FDA recently released draft guidance on “Digital Health Technologies (DHTs) for Remote Data Acquisition” (here). The agency has scheduled a hearing on the draft guidance on February 10 from 1 to 2:30 (meeting information). Comments are due by March 22.
Upcoming Alliance Webinar. The next Alliance webinar is “How FDA Is Funded” featuring Alliance Board Member Emily Holubowich and Executive Director Steven Grossman on Wednesday, February 2, 2022, at 3 p.m. To join us, please sign up here.
Upcoming webinars will feature the Center directors and other senior FDA leadership. Keep an eye on listings in the Friday Update to know when these will be held and to sign-up.
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
Why Sign Up to Learn “How FDA is Funded.” FDA funding is complicated—more so than most other federal agencies. While FDA benefits from multiple funding sources, this also creates confusion about which sources of money support which activities. Our webinar will review the five distinct types of FDA funding and explain the implications. This webinar is particularly important in a year when both the appropriations process and renewal of user fee agreements will be before Congress at roughly the same time.