Today, Drew Armstrong, the Executive Editor at Endpoints News, joined me in The Doctor’s Lounge to break down recent news at the FDA. Our interview was promoted by Drew’s scoop on Dr. Vinay Prasad's abrupt departure as the FDA’s Chief Scientific Officer and Director of the Center for Biologics Research and Evaluation (which made Prasad the nation’s top vaccine official).
We covered Prasad’s brief, but busy and contentious tenure, including:
The Sarepta controversy and how muscular dystrophy drug politics collided with FDA leadership and a right-wing hobby horse that had become the center of two scathing Wall Street Journal editorials.
What happens when FDA scientists disagree with FDA leadership on key decisions. This is not new, but the frequency and intensity of these debates escalated dramatically upon Prasad’s arrival at the agency. We covered how these debates often play out and what made the last several months different.
Repeatedly, we covered how some unexpected FDA decisions (i.e. rejections) in the last few weeks tanked stock prices overnight.
Whether the FDA is drifting toward rigid evidence standards or more libertarian-style deregulation.
The increasing politicization of the FDA. (Again, not entirely new.)
What’s next for the FDA: Will Commissioner Dr. Marty Makary promote someone from within the FDA to replace Prasad in an effort to calm the waters?
Our conversation was a deep dive into how politics, science, and industry have begun to intersect in new ways at the FDA. The future of drugs and medical devices is on the line…so this conversation felt like an important one. It was great to have Drew’s expertise, earned from years of dogged coverage of this beat. I’m sure you’ll agree that he was a fantastic guest.
Closed captions (㏄) for this video and a transcript option (📄) can be found beneath the video playback control bar above. A summary with timecodes can be found below.
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If you have information about any of the unfolding stories we are following, please email me or find me on Signal at InsideMedicine.88.
