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.
Dr. G. Caleb Alexander, MS, is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health.
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.
The FDA’s pivot from ad comms to ‘expert’ panels is bad medicine—STAT
An FDA panel spread misinformation about SSRI use in pregnancy, alarming doctors—NPR
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