FDA Matters Blog
The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story.
Reactions ranged from “Omigod, he’ll destroy the industry and the hope of patients” to “no big deal, staff do the product reviews regardless of who runs the Center.” Experience tells me his tenure is likely to be a little bit of both….but mostly other things that have to do with leading CBER during a time of great promise for products within its jurisdiction.
After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plausibly deniable truth, and sometimes things entirely made up and called the truth.
Several decades ago, when I was a Senate staffer, I observed that I could spend the entire Gross Domestic Product on the good ideas that people brought to us. I soon learned that lawmaking requires a substantial amount of restraint and a lot of prioritizing. Those are hard virtues to develop and very hard to keep when you face voters every few years.
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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