FDA Matters Blog
FDA’s responsibilities have not changed since January 20th. However, its capacity to carry out its duties has been meaningfully reduced by the Administration’s downsizing. We should all be able to agree on that.
Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024, I am sure he believed that Trump 2.0 would be a hospitable place to harness those personal attributes in the cause of a more effective, consumer and patient-focused FDA.
There is a document widely-circulated this morning that purports to be the OMB passback to HHS of the draft proposed FY 26 HHS President’s budget request. It includes proposed numbers for FDA funding for the coming fiscal year.
While FDA’s responsibilities have not changed, its capacity to perform its duties has been significantly reduced. After subtracting approximately 4,500 employees from the agency’s 19,000 employee workforce, it cannot possibly sustain its heavy workload.
Outrage is justified…
Earlier this week, I posted an “FDA-Related Thought of the Day.” According to LinkedIn, it has generated an astounding 29,796 impressions. That’s a lot more interest than it garnered when I first posted it a month ago (here). Here is what I said:
Last Thursday, Alec Gaffney of AgencyIQ declared “…the future of FDA’s user fee programs is in extreme jeopardy” (here). Alec has a well-deserved reputation as one of the best FDA analysts. Alec talks; people listen.
For the most part, I agree with him and have been building up to this conclusion since January
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First appeared in Food Safety News. Reprinted with permission.
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Secretary Kennedy’ announcement came last Thursday: FDA’s contribution to the pending HHS reduction in force (RIF) would be 3,500 employees. That is not quite 20% of the agency’s total workforce. The RIF would be in addition to an unknown number of FDA employees who have already taken buyouts (voluntary separation).
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In theory, you could RIF 3,500 FDA employees and agree to x number of buy-outs, and still have an agency that could competently carry out a portion of the agency’s vast responsibilities. However, it would be extraordinarily hard to do and impossible without a well-developed plan for what functions can be downsized and which employees eased out.
If things went really bad at FDA, who would still be there at the end—caring enough about the agency and public health to keep fighting? My answer would be Dr. Peter Marks. I know you would agree.
Peter has been grace and integrity personified, as well as a defender of our collective faith in the value of data and science. Human betterment has always been Peter’s goal, regardless of where it led him. We should all adopt that same goal and that same attitude.
Peter’s leadership has spanned pandemic response, biotechnology, cell and gene therapies, blood products, rare diseases, regulatory science, vaccine development, and myriad other areas.
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Steven answers questions about the FDA RIF:
Relative to the FDA workforce, how big is the RIF?
Will the RIF exemption be “reviewer” or “reviewer teams,” “inspectors” or “inspector teams?”
Will so-called “user fee employees” be protected from the RIF?
and more on FDAMatter.com today! https://www.fdamatters.com