FDA Matters Blog
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
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
Zero-Based Defense (ZBD) of Critical Government Programs
Passage of FY 25 CR: FDA Level-Funded But Other Programs Hit
Multiple Budget Battles Yet to Come: FDA at Continued Risk
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.
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Taken From This Week’s Headlines
Makary Makes Commitments to Senators and Other Observations
March 14 Government Shutdown Cannot Be Ruled Out
User Fees Still Likely to Continue, But Not a Sure-Thing
What I Am Reading: More on Extending Health Lifespans
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…