Short Takes and Updates—March 7 2025
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1. Taken From This Week’s Headlines
Elon Musk learns there is a Budget Control Act protocol, known as recissions, for cutting appropriated funding. He just needs to talk with Congress. (Roll Call March 6 2025)
Per Trump: Cabinet Secretaries, Not DOGE, Decide Agency Lay-Offs. (Federal News Network March 4) (Politico March 6).
2. Makary Makes Commitments to Senators and Other Observations
The purpose of most confirmation hearings is for Senators to gain commitments from nominees that restrict their decisions once in office. (see Lessons from Dr. Gottlieb’s 2017 Confirmation Hearing).
That was in full display at Dr. Makary’s hearing where practically every question contained the phrase: “...will you commit to taking this specific action?” and many of the answers contained the phrase: “….I commit to take the following action.”
Also, it was clear why nominees are never made “acting” in the post to which they are nominated. It allowed Dr. Makary to say: “I had no prior knowledge of the lay-offs” and “I was not consulted about the cancellation of the flu vaccine meeting.” As far as I know, completely honest answers, but also effective in diffusing some of the most potentially difficult questions.
Overall, Dr. Makary answers reflected his intelligence and quick mind. On some points, I agreed with what he said and on others I have serious concerns.
One of his comments was misleading. In parrying a question about the lay-offs at FDA, Dr. Makary noted that the agency staff had doubled since 2007, implying that maybe the agency had grown more than it needed to. Even if it is true that staff doubled[1], it should not be a surprise since–in this same time period–the agency’s budget more than doubled and the agency’s responsibilities multiplied and became far broader and more complex. This illustrates why the FTC (and FDA) advertising standard is that “statements must be truthful and not misleading.”
3. March 14 Government Shutdown Cannot Be Ruled Out
The FY 25 Continuing Resolution only funds government until next Friday (March 14). Supposedly, a deal is in the works that would cover the remainder of the year. If not, maybe Congress will pass another short-term CR. It is unlikely but still possible that we could have a government shutdown.
As the deadline draws near, there are likely to be reports that about 75% to 80% of the FDA workforce will still be on the job because of various public health and safety exemptions and the availability of user fees.
However, that assumes the Trump Administration will utilize the existing FY 2025 contingency plan (as of last October 1) and make minor adjustments for lay-offs. Plans from a decade ago retained many fewer employees than the 2025 plan. There is a non-zero chance that the Administration chooses those earlier (lower) levels to reinforce their “smaller government” theme.
4. User Fees Still Likely to Continue, But Not a Sure-Thing
The process of negotiating the next set of medical product user fees would normally start with some public hearings in the Summer or Fall of this year. That allows enough time to have user fee legislation before Congress by January 2027.
In my Short Takes column of February 14 (here), I suggested that the new Administration might want to begin sooner and have a broader conversation about the purpose and value of user fee programs.
This week, AgencyIQ (in a members-only analysis of recent EO’s and prior RFK, Jr.’s statements) concluded that “user fee programs could undergo major reforms, or even be terminated, during the next reauthorization cycle – all over concerns about undue “industry influence.”
5. What I Am Reading: More on Extending Health Lifespans
If you were intrigued by last week’s column (here) on extending the span of life free of chronic diseases and disabilities, you can find more on the topic at: Healthy Longevity For All | The Kitalys Institute and Home | Targeting Healthy Longevity. If you want to read the transcript of last Friday’s webinar on FDA and the development of so-called “healthspan” products, the transcript can be downloaded here.
6. What I Am Listening to: FDA Watch/The Evolution of Clinical Trials
Shelly Garg and Wayne Pines’ FDA Watch Podcast featured me and Anthony Brogno of Lindus Health. You will hear our thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration, and much more. You can listen to the podcast here.
I could not confirm the number of staff in 2007 because FDA budget documents have been taken off the agency site and apparently have not been restored.