Short Takes and Updates -- September 5, 2025
FDA Matters doesn't cover the news....we provide analysis of what's behind the news
This week:
My Comment on Secretary Kennedy’s September 4 Appearance Before the Senate Finance Committee
MAHA Strategy Plan Likely to Be Released Week of September 8.
MAHA vs. MAGA: Much Ado About the Usual Interest Group Politics?
HIMS vs. Novo Nordisk Advertising: What I Saw While Watching College Football
What I Am Listening To: FDA Watch Podcast with Wayne Pines and Paul Kim
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My Comment on Secretary Kennedy’s September 4 Appearance Before the Senate Finance Committee. A reporter asked me. Here is what I told him:
“As political theatre goes, it was an excellent hearing. It turned heavily on Kennedy’s stubborn self-assurance and unwillingness to depart even an iota from his well-rehearsed script. As a rule, actual shouting matches are rare, but there were several.
As to the consequences of the hearing...you can’t judge the room by what was being said. What matters is what Senators say to each other about Secretary Kennedy when the cameras aren’t rolling and no one else can hear.”
MAHA Strategy Plan Likely to Be Released Week of September 8. According to Helena Bottemiller's Food Fix (subscribe at www.foodfix.co), the MAHA strategy plan is likely to be released next week. I wrote about this topic twice when I thought the launch would be in August:
“A Message to MAHA: Every American Should Have Access to a Healthy and Affordable Diet" (https://bit.ly/4mxWUS8), and
“My specific message to media & advocates” (first question at https://bit.ly/4gdyaMA)
To sum up my thoughts: 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.
I have urged the media and lead advocacy organizations to focus on the primary goal: providing better dietary options that Americans can afford, access, and integrate into their lives. The safety of food additives is a real issue, but it should be secondary.
MAHA vs. MAGA: Much Ado About Politics as Usual? Over the last week, several press accounts have played up the differences between traditional MAGA (Make America Great Again) constituencies and the comparatively new MAHA (Make America Healthy Again) constituencies.
Oversimplifying it a bit, the first category includes agricultural interests, particularly farm communities that voted decisively for President Trump and are mostly okay with the status quo. The second category is mainly comprised of conservative moms who support HHS Secretary Kennedy’s view that Americans, particularly children, are being poisoned by our food supply and that an increase in childhood chronic diseases is the result.
The forthcoming battle (and there will be a battle) is going to be as DC-traditional as they come. Elected officials--who want the love--and votes--of everyone will try to placate both interest groups and will likely find that’s “mission impossible.”
There are only two likely outcomes: compromises are made and something happens. Or after months of shouting, the process breaks down completely. Nobody is going to lose their job over the melee.
To be specific, I don’t know who the HHS Secretary will be 24 months from now, but if Kennedy is gone, I don’t think it will be because MAGA and MAHA clashed.
HIMS vs. Novo Nordisk Advertising: What I Learned While Watching College Football.
I thought I was taking a break when I joined a friend to watch Notre Dame vs. Miami last Sunday night. Mostly it worked that way....except there was a HIMS commercial promoting its offering of GLP-1 drugs. About 10 minutes later, there was a Novo Nordisk ad for Ozempic.
The ads provided an instructive comparison. The HIMS product is a compounded, unregulated product. Despite the absence of a market shortage that would permit mass compounding, it continues to be sold. It is neither an originator nor a generic drug. It is not manufactured in a facility that is subject to FDA inspection.
As an unregulated compounded product, HIMS is not required to meet any of the “fair balance” and “disclosure” requirements for drug advertising. The HIMS ad could have been an ad for any consumer product.
In contrast, the Novo Nordisk ad contained disclosures of side effects and presented a fair balance between risks and benefits. There was plenty of information that made clear that it was not just another consumer product.
It doesn’t seem fair that an unapproved product claiming to be “just the same” can advertise without restrictions, while the FDA-approved product has significant limitations on what can be said.
What I Am Listening To: FDA Watch Podcast with Wayne Pines and Paul Kim. I enjoyed listening--and learned a lot--from “Dissecting the Direction of CDER and CBER with host Wayne Pines and his guest, Paul Kim. Well worth your time to listen. here
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