House Recesses with No Further Action on Appropriations; Senate to Resume Session Next Monday
This week’s Analysis and Commentary considers the prerequisites for a budget deal, the renewed threat of a shutdown, and best/worst cases for FDA’s FY 24 budget.
House Recesses with No Further Action on Appropriations; Senate to Resume Session Next Monday. The House has recessed without taking any further action on any appropriations bills. The Senate also has not taken action on any other appropriations bill. Senate Majority Leader Schumer (D-NY) announced on Thursday that the Senate will resume session on Monday, giving negotiators from the White House, Senate Democrats, and Senate Republicans time to work through the weekend in an effort to reach a framework agreement on the supplemental appropriation bill providing funding for Ukraine, Israel, Taiwan, and border funding.
Looking ahead, the Senate is scheduled to return to session on January 8, and the House on January 9. When the two bodies return they will have only about ten days to complete action on the Agriculture/FDA, Military Construction and Veterans Affairs, Transportation and Housing and Urban Development, and Energy and Water appropriations bills before the current Continuing Resolution (CR) expires on January 19. Congresswoman Rosa DeLauro (D-CT), the ranking Democrat on the House Appropriations Committee, believes meeting the January 19 deadline will be difficult even if there is a deal on a government funding framework by the end of the year.
Top-Line Spending Levels and Other Funding Issues Still Being Negotiated. House and Senate leadership are likely to continue negotiating a topline spending level through the end of the year. Meantime, negotiations continue on individual funding bills regarding both spending levels and policy riders.
Drafting the text of the negotiated measures, and securing both House and Senate passage will be a challenge. Speaker of the House Mike Johnson (R-LA) has said that he will not support further short term CRs. Instead, he has suggested moving to a full year CR, as we reported in last week’s Friday Update (here and here). Senate Appropriations Chair Patty Murray (D-WA) objected to this proposal. Senator Murray’s full statement can be found here.
FDA Advances Food Program Reorganization, Releases More Details. FDA has advanced its reorganization to HHS review and released more details (here). If approved, the plan would create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model, including additional details about the proposed structure, status of activities and timeline for next steps.
Notably, the details released this week provided a clearer picture of how the reorganization will affect the entirety of the agency and not just CFSAN and ORA.
In addition to the announcement, there is analysis at Regulatory Focus, Food Safety News, Food Safety News–just the food provisions, Food Beverage Insider, and Agency IQ. Also, Alliance member Personal Care Products Council released a statement.
The Alliance Concludes 2023 Webinar Series; Preparing 2024 Speakers and Dates. Dr. Marks' presentation on December 4 concluded the Alliance’s webinar series for the year. Altogether, we had 18 webinars in 2023, including: two programs with Commissioner Califf and at least one each with all the Center Directors and the new Deputy Commissioner for Human Foods. Transcripts of these webinars can be found on the Alliance Events page.
We are in the last stages of lining up speakers for the first quarter of 2024. We promise an exciting and educational array of programs. Do you have a senior FDA leader who you would like to hear speak at one of our webinars? Alliance members (only) can send a note to Executive Director Steven Grossman with suggestions (sgrossman@strengthenfda.org).
FDA’s Oncology Center of Excellence Launches Website on Clinical Endpoints. The Oncology Center of Excellence has enhanced its commitment to innovation in clinical trials by launching a new webpage (here) devoted to advancing novel clinical endpoints.
Friday Update Returns January 5. Friday Update will not publish on December 22 and 29. It will return on January 5.
If events warrant, we will provide intermittent updates between now and January 5. While Friday Update will be taking a rest, the Alliance’s staff remains available to you during this period should you have any questions or needs.