Q&A - July 18, 2025
Dear FDA Matters subscribers–—Each “Q&A Friday” will go to subscribers first, then posted on the website a week later. 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 weekend, Steven
· If you were away the week of July 7: FDA in a Post-Reconciliation World
· July 18: Food User Fees: The Good, The Bad...and the Possibilities
· Linked-In exchanges: National Priorities Vouchers and Unmet Medical Need, More on Health Canada and GLP-1’s, and Join the discussion on Food User Fees.
Q&A FRIDAY—July 18, 2025
This week’s Q&A Friday features questions on:
· the FDA panel on HRT therapy,
· the OTC Monograph user fee reauthorization
· FDA action on standards of identity for food.
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Q: What do you think of this week’s FDA panel on HRT therapy for menopausal women?
A: I like the quick elevation of an important issue, which should hasten its resolution. I like the fearlessness in taking on a long-standing and widely-debated medical controversy.
The process, however, has been deficient on so many levels that it is hard to know how much credence to give it. Poor adherence to process renders any conclusion highly suspect.
While FDA’s traditional advisory committee system is time and labor intensive and can be slow, it has served FDA very well for many years.
It’s not a perfect system. However, there is a degree of confidence in the results....solely because of the due diligence which is at the core of the required process. Committee members are chosen for their varied views and experiences; then vetted for conflicts; meeting notices are usually released early; briefing books are available three days before the meeting; FDA presents its position; and there is a public comment period and public deliberation over a variety of views.
None of these steps were followed in convening the HRT review panel (NY Times story). Since norm-breaking in general--and a lack of commitment to process in particular--are hallmarks of the Trump Administration (my column here), we can expect more FDA meetings will use this truncated process.
Nonetheless, I am hopeful that a return to regular processes may eventually occur at FDA, at least some of the time. Prospectively following protocol (e.g., the Federal Advisory Committee Act) can be time-consuming, but the alternative (expert meetings with no balance, no vetting for conflicts, and no FDA presentation) lacks the credibility that has been the hallmark of the FDA’s past actions.
We should wait to see whether this experiment stands the test of time. If the meeting results aren’t readily accepted, then maybe the old FDA advisory committee process might start looking good to FDA’s new leadership.
Q: Is there any current issue that you feel is not getting the media attention it deserves?
A: Yes, the reauthorization of the OTC Monograph User Fee program, which must be enacted into law before October 1, 2025. Discussions have started in the House Energy and Commerce Committee on a pending bill, and I know of no threat to the reauthorization that would prevent the renewal from occurring.
What seems uncovered is the question: how will the discussion around the OMUFA renewal impact the just-starting-to-be-discussed reauthorization of the biggest user fee programs? That process must be completed in time for the President to send a proposal to Congress by January 2027 (18 months from now).
Q: What are standards of identity--why do we have them, why is FDA withdrawing some now?
A: As is often the case, Food Safety News, one of the best publications to have in your inbox every morning (and free), summed up the situation well:
“The FDA began establishing Standards of Identity (SOI) in 1939 and has since put into place more than 250 of these consumer protections. Products including milk, milk chocolate, various breads, peanut butter, and ketchup have an SOI. The standards often describe in detail what a food must contain and what is optional and sometimes describe the amount or proportion of ingredients or components. Many SOIs also prescribe a method of production or formulation. The goal of the plan to revoke SOIs is to permit the food industry flexibility of the covered foods.” (here)
This sounds good--get rid of obsolete regulations, provide industry flexibility, and continue to protect consumers with SOI’s that are current and needed. So far unmentioned (and unanswered) is a tongue-in-cheek question: Does this action enable five new, presumably needed, regulations to be advanced under the Administration’s standard of getting rid of ten regulations for every new one?
In a recent column (here), I explored how massive cuts to Medicaid, SNAP, and other health and feeding programs are likely to lead to increased consumer fraud in food and medical products.
In light of that, I hope this action--which has been presented as removing obsolete SOI’s--is not the opening salvo in diminishing FDA’s crucial consumer protection role. We need FDA to prepare for a darker world with more incidents of intentional adulteration of foods. As Americans, we cannot afford any weakening of FDA’s inspections and enforcement policies, or any diminishment of the staff assigned to these responsibilities.