Q&A - July 28, 2025
Dear FDA Matters subscribers–—“Q&A Friday” is now “Q&A Monday” so that I can thoughtfully answer questions based on the past week’s news. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.
Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com. I will try to respond to questions in a way that makes all of us a little smarter about FDA.
Have a great week, Steven
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Recent columns
Food User Fees: The Good, The Bad...and the Possibilities (July 14, 2025)
Recent Linked-In and Other Exchanges:
Does Shortening Drug Reviews Risk A Thalidomide-Type Situation
Clinical Leader Reprints My “All of Us Need to Be Rooting for FDA”
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This week’s “Q&A Monday” features questions on:
Is there a “revolving door” issue with Dr. Tidmarsh’s appointment as head of CDER?
Why is the Administration so apparently indifferent to the need for national investment to avoid falling behind China in the life sciences?
What is an important story that is not being widely discussed? (FDA’s headcount)
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Q: Is there a “revolving door” issue with Dr. Tidmarsh’s appointment as director of CDER?
A: I addressed this indirectly in my Short Takes column this past week (here) by pointing out the many similarities in view and style among Commissioner Makary, CBER director Prasad, and Dr. Tidmarsh.
I would expect CDER policy under Dr. Tidmarsh to be closely aligned with the Commissioner’s view that FDA should cut drug review times dramatically through greater efficiencies, while not compromising safety. I hope that Dr. Tidmarsh will extend that thinking to include speedier review of generics, biosimilars, and OTC monographs.
I do not think FDA is corrupted by individuals moving in either direction between FDA and industry. Whatever the image of this exchange might be, the reality is that almost all FDA decisions reflect the input of multiple people. No one FDA staff person can give industry an undeserved benefit and not have it widely known and discussed.(see Picking Apart the Claims That FDA Controls Industry).
Q: Why is the Administration so apparently indifferent to the need for national investment to avoid falling behind China in the life sciences?
A: In my column entitled: “Elon Musk and the Future of Government Investment in Our Nation’s Future,” I looked generally at the retreat from government investment for our nation’s future. Subsequently, I have come to realize Elon Musk was just the public face, albeit a most enthusiastic one. The ongoing influential voice in this debate is really Russell Vought, the head of the Office of Management OMB, who was the author of the Project 2025, a blueprint for downsizing government. He’s not going away any time soon.
To the narrower question of investment in the life sciences, I have been mystified. Early in the year, even when slashing budgets and cutting staff seemed to consume all other priorities, I still expected that life sciences investment would be minimally affected. That proved not to be the case for NIH (in terms of dollars) or FDA (in terms of retained staff). Apparently, cost-cutting did consume all other priorities, including the need to invest in projects that keep us ahead of China.
Attitudes toward competition with China have started to shift, albeit slowly. Commissioner Makary’s National Priorities Voucher (NPV) initiative aims to encourage re-shoring of manufacturing, and you can start to see the beginning of efforts to stimulate development of drugs and biologics by shortening review times.
Until proven otherwise, current obstacles to cutting edge cell and gene therapy should be looked at as situational and transitional, rather than policy driven. We will just have to wait and see if that is true.
There appears to be a growing concern about competition with China that goes beyond the traditional issues: balance of trade, tariffs, rare earth materials, and naval dominance. One important voice for turning the spotlight onto life sciences is the National Security Commission on Emerging Biotechnology (NSCEB), which released a report in April.
Q: What is an important story that is not being widely discussed?
A: The current state of the FDA workforce is important to all stakeholders, but the total headcount appears to be unknown outside the agency. My column on this topic from three months ago is here.
Relative to December 2024, we know the workforce has been reduced by lay-offs, RIF’s, and voluntary separations (whether a response to incentives or in advance of being RIF’ed or natural attrition as people leave the agency for other opportunities).
In the other direction, the decreases in the workforce at the agency have been offset by those asked to return after a RIF notice and the unexpected start of new hiring. I also suspect--although I have no proof--that some of the planned 3500 RIF’s were rescinded before being issued.
It would help to know: FDA has funding for xx,xxx of FTE (full-time equivalent) employees as of July 15, 2025, of which x,xxx positions are currently vacant and are expected to be filled.
Without that--we have no way to assess whether anagency delays (across the agency, not just drugs and biologics) are the result of understaffing, open vacancies, or situational delays that are normal and to be expected.