Q&A - August 11, 2025
Dear FDA Matters subscribers Q&A Monday is a subscriber-first feature of FDA Matters. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.
Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies to: sgrossman@fdamatters.com. I will try to respond to questions in a way that makes all of us a little smarter about FDA.
Have a great week, Steven
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Recent columns:
Short Takes and Updates August 8, 2025 covering
The Difficult Path to An FDA that Is “Just Right,” Neither Too Hard Nor Too Soft
Former FDA Commissioner David Kessler Submits Citizen’s Petition Calling for Action on Ultra-Processed
Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases (July 31, 2025)
Short Takes and Updates July 25, 2025, covering
Imminent Danger Regarding Food Priorities
New CDER Leadership
Re-Exploring Reconciliation Cuts’ Impact on FDA Consumer Protection Responsibilities
Food User Fees: The Good, The Bad...and the Possibilities (July 14, 2025)
Recent Linked-In and Other Exchanges:
· Dr. Prasad’s Return--Comment on STAT Article
· Dr. Prasad’s Return--Grossman Quoted In BioSpace Article
· Former FDA Commissioner David Kessler Submits Citizen’s Position Defining Ultra-Processed Food
· Comment on Montana’s Efforts to Expand Right to Try
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This week’s questions:
· Were you surprised by Dr. Prasad’s return to the agency?
· How important is Dr. Kessler’s citizen’s petition and why do you think it moves the needle on the ultra-processed foods debate?
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Q: Were you surprised about Dr. Prasad’s return to the agency?
A: Yes. Resigning under pressure from the White House and being brought back 10 days later is extraordinarily rare. When Commissioner Makary publicly called for Dr. Prasad’s return, I rated the chance of this occurring as no more than ten percent ...and I considered that an optimistic assessment. So, I was wrong, but the odds were heavily stacked against Dr. Prasad’s return. As Will Roger said: (Trump aside) “there are no second acts in American politics.”
Here is a statement I sent to the press after the announcement of Dr. Prasad’s return: “It takes time for an outside critic to turn into an inside decisionmaker. So, I am guardedly optimistic that he is returning chastened by the realization that neither the CBER director nor the FDA commissioner can make decisions in a vacuum. Lives are at stake. There are multiple stakeholders, notably patients and companies, as well as the President and Congress. They are all paying attention.”
The two columns I have written since he left office might also contribute to his education. The first was published July 31 and the second was published August 8.
· Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases” (bit.ly/46In13B) begins: “Every day, we are failing patients with chronic progressive neurological, neuromuscular, and genetic diseases.”
· The Difficult Path to An FDA that Is “Just Right,” Neither Too Hard Nor Too Soft” (https://bit.ly/4m8HWl2). It critiques why Dr. Prasad was viewed by many as “too tough” on rare diseases, especially progressive diseases that limit human development (think DMD) or are fatal (think ALS).
Q: How important is Dr. Kessler’s citizen’s petition and why do you think it moves the needle on the ultra-processed foods debate?
A: For those not familiar with this question, I wrote about it last Friday at Short Takes and Updates August 8 2025.
So far, most of the MAHA effort has been to state goals--some seemingly outlandish, others merely ambitious--and then pressure states to adopt them and companies to acquiesce to them. The common element is that MAHA doesn’t get too specific or prescriptive about either the details or the actual steps to achieve the goals....and thus doesn’t stand in way of others acting, however disjointed the third party efforts may be.
The key is that they are avoiding (at least for now) the lengthy federal process for public input, consensus building, and rulemaking.
Consider:
· Maybe the food industry can limit its sales of certain foods in West Virginia to avoid new legislation. But it won’t be able to do the same relative to pending legislation in big-market California
· The Trump Administration has expanded the ways in which the government moves private players through threats and uses the bully pulpit. Food companies (wisely I think) have decided to promise to comply rather than face a drumbeat of bad publicity aimed at painting them as enemies of good health.
· The Administration’s Request for Information on a definition of ultra-processed food (responses by September 23) is an important and necessary step but certain to produce a broad array of opinions. That will further delay a federal position and continue to feed the “state laws and company volunteers” approach.
The Kessler petition cuts through all of that--saying not only that “the federal government should do this” but here is the definition, the supporting legal and scientific arguments, and the reason it’s important to act decisively.
Dr. Kessler, always a force to be reckoned with, has once again inserted himself into a public controversy and altered the debate. Whatever any of us think about the substance of the petition, it is pre-emptive of the potentially endless debate about whether there can and should be a viable federal policy on UPF’s.