Q&A - August 25, 2025
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This week’s questions:
Did your column on MAHA intend to deliver a specific message to journalists and lead advocacy groups?
What is the most critical FDA issue in September?
What are some FDA issues that are simmering and will eventually surface?
Do you have suggestions for how I (and others like me) can take meaningful action or contribute to defending FDA, NIH, and CDC?
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Q: Did your column on MAHA (A Message to MAHA: Every American Should Have Access to a Healthy and Affordable Diet) intend to deliver a specific message to media and lead advocacy organizations?
A: MAHA is a slowly unfolding train wreck. Which is a shame because the MAHA movement raises questions about the American food supply and healthy diets that are worth the time and trouble to resolve. Americans deserve better dietary guidance and a more substantial investment in food safety than they currently receive. At this time, it is unclear how we will derive anything of significant value from the process being set in motion as a response to the MAHA movement
The temptation for the media, as well as the public, is to get drawn into the dramatic clash of absolutes. That is the antithesis of the dialogue and compromise necessary to produce profound and lasting changes in healthy diets. It is crucial to keep in mind that healthy diets are far more complicated than limiting or eliminating dyes, pesticides, and preservatives. Nutrition education and access to wholesome, affordable foods are cornerstones to a healthy diet, as well as many other variables discussed in my column.
IMO, the media and lead advocacy organizations have an obligation to reinforce a more balanced view of the situation. This means continuing to emphasize the primary goal: providing better dietary options that Americans can afford, access, and integrate into their lives. Among other things, this forces nuance into discussions where only absolutes would otherwise be considered and reported upon.
Q: What is the most critical FDA issue in September?
A: FDA funding for FY26 will definitely be in play in September. There is the agency-specific aspect — the potential for FDA funding to advance through a minibus bill and actually become law before the end of the fiscal year. That would lock funding somewhat below the FY 25 level but would take the agency outside further budget fights (which are likely to get uglier) and it would allow the FDA to be unaffected by the threat and drama of a potential government shutdown on October 1.
Another aspect of FDA funding is the reauthorization of the OTC Monograph User Fee program, which must be completed by the end of September. This is important in its own right but is also an early signal of continued Congressional support for the other major user fee programs that expire on September 30, 2027.
Q: What are some FDA issues that are simmering and will eventually surface?
A: Here are a couple of issues that I have not written about recently, but which are sure to make headlines and draw concerns in the near future:
FDA Headcount Relative to Its Responsibilities. ProPublica published an analysis last week (here), entitled “How Deeply Trump Has Cut Federal Health Agencies.” I cannot vouch for their analysis or intriguing methodology. However, it serves as a reminder that adequate agency staffing is essential for meeting FDA’s responsibilities.
If, as one might expect, FDA staff are triaging the most pressing items, then it is probably too soon to judge how the smaller workforce can fulfill all the agency’s responsibilities that keep food safe and our medical products safe and effective. My mid-April column, “Rx for FDA: An Agenda for the Commissioner,” discusses the challenge of restarting the agency's “engine of production” after layoffs and disruptions. It’s a notable reminder of where we were just four months ago.
Alternatives to animal research and testing. Over the past 40 years, government, academic researchers, and industry have collaborated to reduce the use of animals in research and testing. It has been hard work, and improvements have been incremental rather than dramatic.
The Administration’s emphasis on increased development and greater acceptance of alternatives is laudable. However, they have overstated how close we are to eliminating animal research and testing. If FDA is not cautious, at some point in the future, there may be deaths or serious morbidities in a phase 1 trial, and there will be a reckoning on why risky preliminary research was not performed on animals first.
Q: As a former FDAer, I’m deeply concerned about the direction in which RFK Jr. is taking the FDA, NIH, and CDC. Do you have suggestions for how I (and others like me) can take meaningful action or contribute to defending these institutions?
A: My own approach is to continue what I have done for several decades: perform policy analyses of issues facing FDA and advocate for positions that help the agency fulfill its responsibilities. I hold the current administration to the same standards that I have applied to its predecessors in the past.
This approach suits my experience and skills but is not generalizable--and would not satisfy your own need to speak out.
Accordingly, I am opening this up to my readers. Are there organizations or other venues for this subscriber to reach out to?