FDA In First Tranche of Agencies Whose CR Expires on January 19

This week’s Analysis and Commentary is entitled “No Predetermined Outcome in Budget Negotiations” and explains why no one knows what will happen next.

Agreement on Top-Line Spending Essential/No Indication of Progress. The House and Senate return to session next week.  Top line spending numbers are essential to any continued and fruitful negotiations on FY 24 appropriations bills. However, apart from occasional unsubstantiated rumors, there are no indications that progress has been made since mid-December. 

The Fiscal Responsibility Act (FRA) provides for total discretionary spending of $1.59 trillion, and purported side deals for an additional $54 billion in nondefense spending. Will these numbers hold?  

What happens next is explored in greater depth in this week’s Analysis and Commentary.

FDA In First Tranche of Agencies Whose CR Expires on January 19. FDA funding is provided through January 19 under a Continuing Resolution funding that covers four appropriations subcommittee bills:  Agriculture/FDA, Energy and Water, Military Construction-VA, and Transportation-HUD.  The remaining eight bills are funded through February 2.  

Options for Future FY 2024 Appropriations Action. There are several options for FY 2024 funding action:

• Complete action by January 19 - This is the best case scenario for FDA funding, contingent upon the actual funding level provided.  It would provide certainty for the rest of the fiscal year as soon as possible.  However, getting four bills done in the next two weeks is unlikely. 

• Another short term CR while action is completed - If there is progress on a House-Senate spending agreement and more time is needed to complete the process, a short term CR to keep agencies open might be necessary to avoid a shutdown.  

• A shutdown while final action is resolved - If there is no final action or extension of the CR, then FDA could be facing a shutdown in just two weeks.  We refer you to our FDA Shutdown Tool Kit for our earlier analysis of the implications.  An updated version will be released if a shutdown starts to look probable. 

• A full year CR - Absent agreement on spending bills, Speaker Johnson has suggested a CR for the balance of fiscal 2024.  However, his approach is not a 1% across the board cut as provided in the Fiscal Responsibility Act. Rather, he appears to favor a total reduction of 1%, with increases in defense and VA programs paid for by much larger cuts to other government programs. 

Sequestration on Hold for Now.  The Office of Management and Budget has issued a memorandum saying, in part, “OMB will determine whether or not a sequestration is required and, if required, the amount required to be sequestered, when OMB issues the Final Sequestration Report required by law. That report is due on the earlier of: 15 working days after all full-year discretionary appropriations bills are enacted, OR April 30.”  

OMB’s message to agencies is: do not attempt to hold back funds against the possibility of cutbacks. OMB will determine when and how much needs to be held back for 3rd and 4th quarter spending.

Implications for FY 2025 Appropriations Action.  Any delay in completing action on FY 2024 spending has implications for the FY 2025 cycle.  First, how much does it delay the submission of the President’s FY 2025 request, which routinely is expected in early February?  Second, what will be the point of comparison for the FY 2025 request - the FY 2023 enacted or the FY 2024 request?   Third, given the Presidential election year, how will Congress move to consider FY 2025 bills?   And, fourth, will the FY 2025 spending levels agreed to in the FRA - $1.605 trillion in total discretionary spending - be honored, or will we see another effort to modify these levels?  

Three Webinars Kick Off the 2024 Alliance Webinar Series:

• Webinar on FDA Reorganization Plan with Senior FDA Leaders, January 19 at 11 a.m. Register here!

  On December 13, 2022, FDA culminated a year-long process by publishing proposed changes and updates to an FDA-wide reorganization plan. Because of the plan’s far-reaching consequences, the Alliance is hosting a briefing with guests:

• Deputy Commissioner Janet Woodcock.

• Chief Scientist Namandje Bumpus,

• Deputy Commissioner for Human Food Jim Jones, and

• Acting CFSAN Director Donald Prater.

  Both food safety and medical product stakeholders will benefit from the webinar because the reorganization plan has a sweeping agency-wide impact.  

  John Taylor (former Acting Deputy Commissioner for Global Regulatory Operations and Policy) and Alliance Board member. Sarah Sorscher (Center for Science in the Public Interest) will be the co-moderators.

  Two More 2024 Webinars Announced: 

• Dr. Robert Califf, FDA Commissioner on Wednesday, January 31st at 2:00 p.m. ET. Register here: Califf event registration. See Dr. Califf’s bio here.

• Kimberlee Trzeciak, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, February 8 at 3 p.m. See Ms. Trzeciak’s bio here. Register here! NOTE this is a rescheduled Time for Ms. Trzeciak’s presentation; not the original date.

You can also find all the transcripts & summaries of our past Alliance webinars on our website here.