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.
  
  Read more…

• 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

read more…

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

read more...

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…

1 FDA At Risk on Four Fronts
All the federal public health programs are under siege. While my focus is on FDA, I want readers to know that NIH and CDC face similar (but not identical) threats. 

Reduction In Force (RIF). The new Administration sent lay-off notices to…read more…

FDA employees--public-spirited and committed—are the heart of the agency and can proudly point to a lengthy record of accomplishment. Our country has safe food and safe and effective medical products because of their efforts. We are all affected: every American uses FDA-regulated goods and services at least several times each day…. read more…

1 When Will Congress Engage on the Future of FDA User Fees? Either the agency is captured by industry (Secretary Kennedy), or it is a hindrance to industry (Vivek Ramaswamy). I understand how it could be neither…but not how it can be both…read more…

Part 1: Meaningful Deficit Reduction Requires More Than Cuts to Discretionary Spending

In FY 2024, the federal government spent $6.75 trillion and collected $4.92 trillion in revenue, resulting in a deficit. The amount…

Today is the first “Short Takes and Updates” column. For those who have not signed up to receive the FDA Matters newsletter in your email box, go to the home page to register.