FDA and Politics: An Unhealthy Combination

by Steven Grossman | Apr 22, 2025 | Short Takes and Updates

Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024[1], I am sure he believed that Trump 2.0 would be a hospitable place to harness those personal attributes in...

Leaked FY 26 FDA Budget Document Explained

by Steven Grossman | Apr 17, 2025 | Short Takes and Updates

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. It is still subject to negotiation...

Rx for FDA: An Agenda for the Commissioner

by Steven Grossman | Apr 15, 2025 | Short Takes and Updates

While FDA’s responsibilities have not changed, its capacity to perform its duties has been significantly reduced. After subtracting approximately 4,500 employees[1] from the agency’s 19,000 employee workforce, it cannot possibly sustain its heavy...

Chesterton’s Fence: The Meaning of Deregulation & Other Thoughts About FDA

by Steven Grossman | Apr 11, 2025 | Short Takes and Updates

Earlier this week, I posted an “FDA-Related Thought of the Day.” According to LinkedIn, it has generated an astounding 29,796 impressions (and counting!). That’s a lot more interest than it garnered when I first posted it a month ago (here). Here is what I said...

The Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking

by Steven Grossman | Apr 7, 2025 | Short Takes and Updates

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...