Elon Musk thought cutting government programs was about deficit reduction. When the “One Big Beautiful Bill” reconciliation legislation passed the House with a $3 trillion price tag, he realized he had been misled and reacted accordingly.

I welcome Commissioner Makary’s embrace of AI and applaud yesterday’s announcement of the next step in agency adoption of AI technology. 

I wrote earlier that: “AI can help FDA make better regulatory decisions based on more refined and accurate information…

“While discretionary spending is not part of the reconciliation process, some policymakers may point to savings from that category as “offsets” for other policies.”

FDA makes significant contributions to public health, public safety, scientific and technological innovation, US investment, and the flow of commerce—producing a positive return-on-investment that far exceeds its budget. Yet, owing largely to our nation’s ongoing and precarious fiscal situation, it gets harder each year to convince the Administration and Congress to provide FDA with robust funding.  

Today, May 22, 2025, is the last day that mass compounded GLP-1 obesity medicines can be sold. Yet, some companies intend to continue selling compounded GLP-1 drugs to a large number of their customers by gratuitously adding other ingredients or making similar modest and unnecessary change…then saying it is being compounded for the special medical needs of a specific patient. The hypocrisy is clear: a special medical need is not a mass need. 

The most important questions facing FDA and the stakeholder community are: 

After the lay-offs, RIFs, and voluntary departures, does the FDA have enough staff and expertise to fulfill the agency’s responsibilities?

If there are tasks and obligations that will not be met--or not met in a specified timeframe--will the agency address statutory, Congressional, and stakeholder concerns? 

“Flooding the zone” has worked as a strategy for the Trump Administration, at least so far. We are all so busy reacting to the newest proposals that we don’t have time to address the previous week’s initiatives from the Administration.

While I can’t seem to get ahead, I usually have a good sense of what is coming next or, at least, the range of possibilities. That’s an important aspect of both my FDA Matters writing and my client work.

I am tired of the continued defamation of FDA as an agency controlled by industry. 

That is not to say that FDA is perfect or that there have never been FDA-industry interactions that looked (and maybe were) bad. However, as a generalization….no, FDA is not controlled by industry. 

Such allegations are usually based on ignorance or a genuine misunderstanding of how FDA works. Sometimes it is hard to tell, as with recent statements that advisory committees: decide drug approvals…

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

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). 

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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. 

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