HHS Posts FY 2024 Contingency Staffing Plan, Including FDA Materials
The Alliance is a resource for the entire FDA stakeholder community. We welcome your questions about FDA and what may happen should there be a government shutdown (send questions to sgrossman@strengthenfda.org).
Please consider this week’s Analysis and Commentary that further addresses the likelihood of a shutdown and the Alliance’s FDA Shutdown Tool Kit released today.
HHS Posts FY 2024 Contingency Staffing Plan, Including FDA Materials. The Department of Health and Human Services has now posted contingency staffing plans for the department and its agencies. The key excerpt from the FDA portion is “In the event of a lapse of appropriation, 15,602 (81%) of FDA staff will be retained including 12,300 (64%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,302 (17%) who are excepted (their activities are deemed necessary by implication, or for the safety of human life or protection of property).”
The Alliance released its FDA Shutdown Tool Kit today to reflect this updated information. The Tool Kit will be updated regularly as long as there is a threat (or the actuality) of a shutdown.
House Appropriation Status – No Action this Week; CR Still Unclear. Certain House members continue to object to the consideration of any appropriations bills, despite efforts to reach accommodations. As a result, the House twice tried and failed to adopt rules that would allow floor consideration of the FY 24 Defense Appropriations bill. House Republican leadership has allowed for the possibility of weekend votes but have otherwise allowed Members to return to their districts until Tuesday.
Similarly, there was little progress in the House on adopting a Continuing Resolution (CR) that would avoid a government shutdown on October 1.
In an effort to find a compromise, members of the House Freedom Caucus and the Main Street Caucus developed a CR to fund the federal government at reduced levels through October 31. [here]. Under their proposal, overall spending in October would be set at a one-percent decrease. However, the Defense Department, the Department of Veterans Affairs, and certain disaster relief funding would be exempt from this reduction. Consequently, all other discretionary spending, including FDA, would be reduced by 8.1285 percent for October. The proposal also includes extensive legislation on border security.
That proposal gained no immediate traction because some Members thought it didn’t cut funding enough. However, with a lower level of funding inserted, it has become the core of a deal on which Speaker McCarthy is trying to gain consensus, adding additional pieces to try to gain additional Republican votes.
An alternative—though seemingly unlikely—pathway centers around a discharge petition for a traditional CR that continues government at current funding levels that has been signed by all 213 Democratic House members. If 5 House Republicans signed as well, it would force a floor vote on that alternative measure. Some House Republicans from districts won by President Biden have talked about signing the discharge petition if there is no hope for any resolution other than a shutdown. Presumably, the threat gives them some leverage in the Republican caucus, but from a political perspective, it is nearly impossible to imagine them actually signing the petition.
Senate Adjourns Until Next Tuesday with An Evolving Appropriations Agenda. The Senate adjourned Thursday afternoon until next Tuesday without further action on any appropriations measures, including the minibus that includes Agriculture/FDA funding. Discussions are ongoing to see if the bill can be considered next week.
At week’s end, the Senate has not advanced a CR. However, Politico reported Thursday night that “Senate Majority Leader Chuck Schumer has moved to begin debate on a House bill that could serve as a vehicle for a continuing resolution keeping the government functioning past September 30. The move to tee up the [House-passed] House FAA bill is a signal that Senators have lost patience with the House as it flounders in its attempts to pass any sort of appropriations legislation. With the chamber out Monday for Yom Kippur and a shutdown looming just four days later, Senators have no time to waste.”
The Alliance Hosted a September 19 Webinar on Artificial Intelligence and FDA’s Regulatory Framework. FDA’s Acting Assistant Director of Digital Health Policy MiRa Jacobs, PhD discussed the integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.
She answered questions like:
What are the primary challenges the FDA faces with the growth of products that incorporate AI?
If a company plans to include AI in their product development, when should they approach FDA and who should they approach?
In your view, how close are we to AI tools like large language models being ready for primetime in terms of real-world medical applications?
To learn the answers to these questions, you can read the webinar transcript here and the summary here. You can also find all the transcripts & summaries of our past Alliance webinars on our website here.
Biden Administration Proposes New Rule to Bolster Job Protections for Federal Workers. As many recall, the prior administration, sought to create a new federal hiring “Schedule F” that would permit the president to appoint political allies to replace career government officials who work on policy matters. This was seen as a threat to the Civil Service and of particular concern to FDA, which usually has only one political appointee (the Commissioner).
The Biden administration has proposed a new rule that would bolster job protections for federal workers and make it harder to implement a Schedule F. The proposed rule and some reactions to it are in this Washington Post article.