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

Read more…

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). 

Read more…

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. 

Read more…

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

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  This past Friday’s column--“What’s Happening to FDA Employees: An Analogy Can Help” (here)—was one of my most widely-read articles.  While the analogy helped many readers, the most important thought was in the last paragraph:  

  The key learning from the 1990’s [government downsizing] is that most, if not all, federal employees would support downsizing if it is planned, reasonably paced, and predictable. The current effort is just the opposite in all three regards.
  
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• The Federal Workforce is Large….FDA’s Is Small But Important

• Deficit Reduction Will Reduce the Federal Workforce….FDA Is Affected But Not Specifically Targeted

• President Clinton Significantly Reduced the Federal Workforce…But This Is Different

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Short Takes and Updates—March 14, 2025

1. Zero-Based Defense (ZBD) of Critical Government Programs

2. Passage of FY 25 CR: FDA Level-Funded But Other Programs Hit

3. Multiple Budget Battles Yet to Come: FDA at Continued Risk

4. What I am Reading: Proposed Cuts to Medicaid

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On Monday, I had the honor to address the annual meeting of America’s Blood Centers (ABC). It reminded me how much I learn by preparing for speeches and panels. 

From this current effort, I have three main take-aways to share, each quite different from the other: 

• Understaffed regulatory agencies (i.e., FDA) will tend to say “no” much more often if they do not have the staff, time, or focus needed to reach a nuanced “yes.” Think of the breakthroughs at FDA; think about how much extra time and staff those have required. 

read more…

1. Taken From This Week’s Headlines

2. Makary Makes Commitments to Senators  and Other Observations

3. March 14 Government Shutdown Cannot Be Ruled Out

4. User Fees Still Likely to Continue, But Not a Sure-Thing

5. What I Am Reading: More on Extending Health Lifespans

6. What I Am Listening to: FDA Watch/The Evolution of Clinical Trials

   and more…

President Trump nominated Johns Hopkin Professor Martin Makary to be the next Commissioner of FDA. His confirmation hearing is Thursday, March 6 at 10 a.m. The livestream will be here.

As with confirmation hearings generally, the ostensible purpose is to determine Dr. Makary’s fitness  to be FDA Commissioner. I expect the Senate HELP committee to conclude that he is qualified. The Senate should confirm him in March or early April…

I never intended FDA Matters to focus only on the new Administration or on existential threats to FDA. Nonetheless, that is mostly what you have gotten from me since we launched on January 10. 

I need a break. Maybe you do, too? Let’s talk instead about living longer and healthier…

FDA Matters, The Grossman Report latest edition: Never Lose the Whip Count, The Disconcerting Consequences of Lay-Offs By Fiat, and User Fees and Lay-Offs at FDA. Read more…

Information for Reporters 

Last Saturday’s Reduction in Force (RIF) at FDA included some FDA employees whose salaries are “fully paid by user fees.”  This surprised many and set off a lot of speculation as to how that saved the government money and whether it meant that FDA was unilaterally changing the terms of the user fee agreements. 

Read More…