Current status: appropriations and reconciliation; Is the schedule for FY 23 appropriations cycle becoming clearer?
Top-Line:
Analysis and Commentary about the Continuing Resolution and possible omnibus FY 22 appropriations bills.
Current status of appropriations and reconciliation.
No Senate vote scheduled yet for Dr. Califf.
Schedule for FY 23 appropriations cycle becoming clearer?
Upcoming Alliance webinars:
Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy on Tuesday, January 25, 2022, at 1 p.m.
"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 hear the Acting FDA Chief Scientist.
Why sign up to learn “How FDA is Funded.”
This week’s Analysis and Commentary (below) answers questions about the expiration of the Continuing Resolution on February 18 and prospects for passage of omnibus FY 22 appropriations bills.
Legislative Status: Appropriations and Reconciliation. We know the Chairs and Ranking Members of the House and Senate Appropriations Committees continue to talk, but otherwise there was no movement this week on FY 22 appropriations. For more about the current situation, see this week’s Analysis and Commentary.
Reconciliation—as reflected in the House-passed bill and the Senate draft bill—included $300 million in no-year money for FDA that would be split between data and technology modernization and upgrades to buildings and facilities. The process to pass those bills has stalled and many anticipate that a fresh approach with a lower cost will be the next step. We hope the modernization resources remain in any revised reconciliation package, but there is no way to know at this point.
No Senate Vote Scheduled Yet for Dr. Califf. Dr. Califf’s nomination was voted favorably by the Senate HELP Committee on January 13. Given the intervening federal holiday and the Senate’s current focus on voting rights, it is not surprising that nothing is scheduled yet. Additionally, Politico has reported that FDA’s recent decision to make a leading abortifacient available through the mail, is engendering some unexpected opposition to Dr. Califf. It is too soon to know if that will affect the actual vote on the nomination as opposed to just slowing the nomination down.
Schedule for FY 23 Appropriations Cycle Becoming Clearer? In a typical year, the President would have kicked off the FY 23 cycle with the State of the Union (SOTU) this week or next. OMB would have followed up in early February with the President’s Budget Request. Then the process would have shifted to Congress for hearings, mark-ups, floor votes and so on. Instead, FY 22 is not completed yet (see this week’s Analysis and Commentary) and the President’s SOTU speech will not be until March 1. We have heard nothing about whether the President’s Budget Request will come out before the SOTU (unlikely but not unprecedented) or more likely will come out in March or April. So, everything about the FY 23 cycle is delayed and, to the best of our knowledge, no dates have been penciled in for moving the process along.
Yet, we believe the outlines of the FY 23 cycle have gotten clearer, despite the delays. Regardless of when the process starts, October 1 is still the end of the fiscal year. Similarly, this is an election year and Congress rarely stays longer than about 10 or 12 days into October before going into recess. This means that FY 23 appropriations will need to be completed (or a two-month CR enacted) by the first week of October. From this we conclude: early delays in moving forward on FY 23 appropriations are likely to result in compression rather than extension of the FY 23 appropriations process.
Upcoming Alliance Webinars. The first two webinars for 2022 have been scheduled:
Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy on Tuesday, January 25, 2022, at 1 p.m. To join us, please sign up here.
“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.
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 Hear the Acting FDA Chief Scientist? The Office of the Chief Scientist is a hub for scientific programs that support the Centers, as well as the overall FDA mission. The Chief Scientist oversees the National Center for Toxicological Research and initiatives involving advancing regulatory science, technology transfer, scientific professional development, and scientific integrity. The Office also oversees the FDA’s Medical Countermeasures Initiative (MCMi). It is in the latter capacity that the FDA Chief Scientist has become a central figure in the EUAs that have been issued in response to the COVID-19 pandemic.
Why Sign Up to Learn “How FDA is Funded.” FDA funding is complicated—more so than many other federal agencies. FDA benefits from multiple funding sources, but 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, particularly in a year when both the appropriations process and renewal of user fee agreements will be before Congress at the same time.