Short Takes and Updates -- August 8, 2025
FDA Matters doesn't cover the news....we provide analysis of what's behind the news
This week:
August in DC—No Longer Slow
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 Foods (UPF)
August in DC--No Longer Slow. Years ago, when I ran the planning, evaluation, and policy shop for the Assistant Secretary for Health, I observed that we were just as busy in August--but it was because I had half the staff covering about half the workload!
No more. Even with a full staff it is hard to cover everything going on in DC in August. Here are two “hot” topics to match the summer heat:
The Difficult Path to An FDA that Is “Just Right,” Neither Too Hard Nor Too Soft
Possibly too hard: The writings of CBER Director Dr. Vinay Prasad’s positioned him as generally uncompromising on study protocols and analysis. It did not seem like he was that open to situations where standards might need to be adapted, such as with drugs targeting very small populations. That seemed to put him at odds with Commissioner Makary’s somewhat softer stance on orphan drugs and Makary’s calls for more innovative approaches to drug development.
Dr. Prasad’s initial public comments, including his hour-long presentation at a webinar with the National Organization for Rare Disorders (here), led many stakeholders to believe that he had moved closer to the Commissioner’s views. During his three months at FDA, Dr. Prasad made several decisions that suggested otherwise.
A narrative developed that Dr. Prasad was hostile (or at least uncomfortable) with pushing the envelope on innovative therapies and with relying on “reasonable but not completely proven” assumptions. As a result, there is widespread belief that Dr. Prasad’s departure opens the agency to a less rigid view of orphan drugs and gene therapies.
Definitely too soft: On August 3, a WSJ article (here) exposed Montana's bid to generate medical tourism with an "anything goes" policy toward availability of experimental drug therapies. Specifically, “licensed experimental clinics would be permitted to recommend and administer drugs that have only completed Phase I trials—the earliest stage of human testing, focused on safety rather than effectiveness.” The preceding quote and an incisive explanation of why this is bad policy and bad medicine was written by Alec Ginsberg, the Drug Store Cowboy, and can be found here.
Neither too hard nor too soft? We definitely need a better approach to the challenge of progressive diseases that limit human development (think DMD) or are fatal (think ALS), as I described at https://lnkd.in/eXfJh93j. Dr. Prasad apparently would have required pre-approval endpoints that would have been impossible to meet. On the other hand, the Montana approach is a disservice, maybe providing a glimmer of hope but not much else. It is not a good answer.
Former FDA Commissioner David Kessler Submits Citizen’s Petition Calling for Action on Ultra-Processed Foods (UPF)
Late Wednesday evening, August 6, Dr. Kessler submitted a cover letter (full text here) and a Citizen's Petition to FDA proposing a definition of ultra-processed foods (UPF) (full text here). Media coverage started with the NY Times (here).
In former Commissioner Kessler’s words: I am submitting a petition to the FDA that provides a realistic, science-based, and legally sound path for the Administration to [define ultra-processed foods]. It calls on the Agency to remove processed refined carbohydrates from the food supply on the basis that they should no longer be considered “Generally Recognized as Safe” (GRAS).”
The key questions this raises: Is the definition he proposes operational in practice? Is he correct that there is enough information to withdraw GRAS (permitted to be marketed) status? Does it matter the outcome, if his Citizen's Petition galvanizes debate and pushes forward the possibility of serious action? (CP's have a public relations value apart from the legal issues/outcome requested).
The FDA Matters reaction: "Secretary Kennedy and Commissioner Makary understood that eliminating ultra-processed foods would require a practical, scientifically-sound definition. By homing in on the definition, Commissioner David Kessler’s Citizen’s Petition will force a serious debate and move the needle much closer to action.”
The CP appears to be responsive to (but not a result of) the June 16. 2025 FDA Matters (www.fdamatters.com) (at: http://bit.ly/3UdUqM6). Here are a couple of points from that column: “A key plank of the MAHA (Make America Healthy Again) initiative is to build federal and state policies that result in the elimination of ultra-processed foods (UPF) from the American diet... Is UPF defined by the number of ingredients? By the presence or absence of certain ingredients? By certain processing steps (and which ones)? What, if any, is the level of proof needed to establish a food as “good” or “bad? Something more specific and scientifically-sound is needed."
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