In your discussion of the Glas flavored vapes authorizations, I fear you may not have the correct understanding of the interactions between the civil servants and the political leadership.
FADEL: OK. Let's get to the process here, though. I mean, if the president interjected himself into this decision, like the reporting indicates, what does it say to you about the independence of the agency and its reliance on science?
ZELLER: I've worked on FDA issues since 1982. And the independence of this part of what FDA does, science-based review of applications - whether it's e-cigarettes, human drugs, animal drugs, food additives - that really needs to be held sacrosanct. If the reporting is accurate that the experts at my former center concluded that it was appropriate to market this product, and they were then overruled by the political leadership of FDA, who in turn was then called onto the carpet and told to change his mind by the president of the United States, to me, that constitutes politicization of a process that politics should play no part in.
The job of the regulator, looking at these applications, is like an umpire in baseball. You call balls and strikes. Someone is going to be unhappy for sure, but you follow the science and you follow the law. And that's what my former center did. And then the whole thing became very political. That undermines faith and trust in government and in science.
Thank you for this, Dr Gounder.
In your discussion of the Glas flavored vapes authorizations, I fear you may not have the correct understanding of the interactions between the civil servants and the political leadership.
See this NPR Morning Edition interview of former FDA CTP Director, Mitch Zeller, from Thursday (https://www.npr.org/transcripts/nx-s1-5813637) and this excerpt in particular:
FADEL: OK. Let's get to the process here, though. I mean, if the president interjected himself into this decision, like the reporting indicates, what does it say to you about the independence of the agency and its reliance on science?
ZELLER: I've worked on FDA issues since 1982. And the independence of this part of what FDA does, science-based review of applications - whether it's e-cigarettes, human drugs, animal drugs, food additives - that really needs to be held sacrosanct. If the reporting is accurate that the experts at my former center concluded that it was appropriate to market this product, and they were then overruled by the political leadership of FDA, who in turn was then called onto the carpet and told to change his mind by the president of the United States, to me, that constitutes politicization of a process that politics should play no part in.
The job of the regulator, looking at these applications, is like an umpire in baseball. You call balls and strikes. Someone is going to be unhappy for sure, but you follow the science and you follow the law. And that's what my former center did. And then the whole thing became very political. That undermines faith and trust in government and in science.
________
Thank you.
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I wish it were still so. Many norms have been broken.
This is a good read: https://www.politico.com/news/2026/05/08/makary-leave-as-fda-commissioner-white-house-source-00911981
Stay tuned... I have a related story come out on this soon.