948 - Recent "Expert Panels" Could Undermine the FDA's Credibility
Public Health On Call
The Johns Hopkins Bloomberg School of Public Health
4.6 • 644 Ratings
🗓️ 17 September 2025
⏱️ 16 minutes
🔗️ Recording | iTunes | RSS
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Summary
About this episode:
The FDA has long convened scientifically rigorous advisory committees to review data and offer recommendations for regulating a range of food and drug products. However, it has recently pulled back and leaned heavily into ad-hoc "expert panels" that are not held to the same standards. In this episode: Caleb Alexander, an epidemiologist and drug safety expert who has served on over a dozen FDA advisory committees, raises concerns about the lack of transparency and accountability in these new panels and suggests that their lax standards might undermine the agency's credibility.
Guest:
Dr. G. Caleb Alexander, MS, is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health.
Host:
Lindsay Smith Rogers, MA, is the producer of the Public Health On Call podcast, an editor for Expert Insights, and the director of content strategy for the Johns Hopkins Bloomberg School of Public Health.
Show links and related content:
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The FDA's pivot from ad comms to 'expert' panels is bad medicine—STAT
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An FDA panel spread misinformation about SSRI use in pregnancy, alarming doctors—NPR
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Transcript
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| 0:00.0 | Welcome to Public Health On Call, a podcast from the Johns Hopkins Bloomberg School of Public Health, |
| 0:05.9 | where we bring evidence, experience, and perspective to make sense of today's leading health challenges. |
| 0:16.3 | If you have questions or ideas for us, please send an email to public health question at jh.h.edu. |
| 0:23.8 | That's public health question at jh.u.edu for future podcast episodes. |
| 0:30.8 | Hey, listeners, it's Lindsay Smith-Rogers. |
| 0:33.1 | And today, the FTAs shift from advisory committees to expert panels and what this means for |
| 0:40.1 | science and transparency in drug regulation. Dr. Caleb Alexander, an internist and epidemiologist |
| 0:46.5 | who served on many of these advisory committees for the FDA, typically around pharmaceuticals, |
| 0:51.8 | joins me to talk about the work these committees do and why this |
| 0:55.4 | shift is concerning. Let's listen. Dr. Caleb Alexander, welcome back to public health on call. |
| 1:00.8 | It's been a minute. How you doing? I'm doing great. Thanks for having me. |
| 1:04.2 | Sure. So today we're talking about the FDA and these expert panels, but apparently to get to that, you and I have chat about this, |
| 1:12.2 | we first have to start with advisory committees. Would you give us a little background on |
| 1:16.9 | advisory committees for the FDA in your experience working with these committees? |
| 1:20.8 | Yeah, well, thanks. It's a great question, and I have had the fortune to serve on and chair |
| 1:27.1 | many different advisory committees focused on |
| 1:29.8 | prescription drug regulation for the Food and Drug Administration. |
| 1:33.9 | And, you know, the FDA has a lot of work going on and a lot of regulatory activity. |
| 1:39.3 | And you can imagine that there are a lot of clear calls that they make. |
| 1:42.6 | We're talking here about prescription |
| 1:44.3 | drugs where there's either substantial evidence of safety and efficacy and a product makes it |
| 1:49.8 | across the line, or there's clearly not, and the manufacturer has more work to do. But there are |
... |
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