A Rough Couple of Months for FDA and Other Government Agencies

This week’s Analysis and Commentary is entitled: “Presidential Transition: Coming Soon to the FDA.”
 

A Rough Couple of Months for FDA and Other Government Agencies. The transfer of power from the Biden Administration to a Harris or Trump administration is almost certain to be a difficult time. Alliance Executive Director Steven Grossman describes the process in this week’s Analysis and Commentary, entitled “Presidential Transition: Coming Soon to the FDA.” The Alliance expects to have more to say about this in the coming weeks.

In the meantime–and probably hard to ignore–will be Congress’ struggle to adopt government funding legislation. The current Continuing Resolution expires on December 20. There are strong political forces aligned with finishing the twelve appropriation bills during the post-Election (Lame Duck) session, leaving the new Administration with a clean slate for the FY 25 process to begin in March/April.  

Roughly equal political forces would prefer all funding issues be kicked over to next calendar year, letting the new Congress and new Administration figure out FY 25. The current positions of political leaders are detailed in the news story below, entitled “Appropriations Pathway Remains Unclear.” 

As explained in prior recent columns (here and here), who’s on what side (passing bills now vs. leaving FY 25 appropriations for next year) is likely to be completely scrambled by the outcome of the election. As the second of these two columns discusses–it is not just who is elected President, but next steps are also driven by who will control the House and the Senate next year.

Tarver Named Director of FDA Medical Device Center. Dr. Michelle Tarver has been named director of the FDA’s medical device center, according to a staff email from FDA Commissioner Robert Califf obtained by Politico. The permanent appointment of a longtime FDA staffer means the Center for Devices and Radiological Health will have continuity heading into the start of the next round of user fee negotiations with the device industry.

Alliance Executive Director Steven Grossman commented: “Dr. Tarver is a respected veteran leader within the FDA and will be a worthy successor to Dr. Shuren. In particular, we expect her to continue the Center’s innovative approaches to regulation and its commitment to stay ahead of the curve in the increasingly complex world of medtech.”

The Alliance Webinar Series Continued Yesterday with Jim Jones, FDA Deputy Commissioner for Human Foods. This webinar was our 13th of the year. Find the recording of yesterday’s event here. The transcript, summary, and slides will be posted next week on our website here.

Remarkably, the Reagan-Udall Foundation report (on which Jim Jones was a panel member) came out less than two years ago. A lot has changed in a short period of time, although there is much that still needs to be accomplished. Jones addressed new developments since he last spoke to the Alliance in April. 

FDA: Medical Device Cybersecurity is Crucial to Patient Safety. This week, FDA’s Center for Devices and Radiological Health (CDRH) issued a bulletin to remind patients and stakeholders that, like other electronics, medical devices can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. Informed by patient voices and collaborations with industry, government agencies, and healthcare delivery organizations, the FDA will continue to drive and refine medical device cybersecurity policy.

Appropriations Pathway Remains Unclear. With the uncertain outlook for next week’s election results, the pathway for completing appropriations action remains unclear.   Roll Call reports “...congressional leaders need to figure out what to do about funding the government beyond the stopgap law’s Dec. 20 deadline.”  Steven’s more detailed description of the possible scenarios is here.

While House and Senate Appropriations leadership would prefer to complete action on appropriations this year. Time is tight, however, and Speaker Johnson continues to suggest the Continuing Resolution should be extended until March.  

The House and Senate have eight legislative days from November 12 until Thanksgiving week. The Senate returns from Thanksgiving on December 2 with three five-day weeks before they are scheduled to leave town on December 20.  The House comes back on December 3 for three four-day weeks.  The House is scheduled to adjourn for the year on December 19. 

House Republican Conference elections and Senate Republican leadership elections are both scheduled for November 13, with the expectation the results will play a strong role in further appropriations action.