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WSJ Opinion: Potomac Watch

The FDA's Gene-Therapy Reversal and the Exit of Vinay Prasad

WSJ Opinion: Potomac Watch

The Wall Street Journal

Society & Culture, News

42.7K Ratings

🗓️ 30 July 2025

⏱️ 26 minutes

🧾️ Download transcript

Summary

A top official at the Food and Drug Administration steps down after the agency changes course on a treatment for Duchenne muscular dystrophy. What does this episode say about the Trump Administration's approach toward drug development and innovation? Plus, Robert F. Kennedy Jr. says he plans to overhaul the National Vaccine Injury Compensation Program. Learn more about your ad choices. Visit megaphone.fm/adchoices

Transcript

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0:00.0

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0:09.6

tools. Learn more at OmataHealth.com. Omada Health is proudly NASDAQ listed.

0:17.5

From the opinion pages of the Wall Street Journal, this is Potomac Watch.

0:24.1

A top health official exits the FDA after the agency puts a hold on shipments of a gene therapy for muscular dystrophy and then reverses itself after a public outcry.

0:35.8

Meantime, health secretary Robert F. Kennedy Jr. says he's going to overhaul the National

0:41.2

Vaccine Injury Compensation Program to make it easier for claimants and their trial lawyers

0:47.4

to get payouts.

0:49.3

Welcome, I'm Kyle Peterson with the Wall Street Journal.

0:52.9

We are joined today by my colleagues, editorial board

0:55.7

member Kate Batchelder O'Dell, and columnist Alicia Finley. Vinay Prasad has been the chief

1:02.9

regulator for vaccines and biologics since being appointed to the agency in May, but he is now

1:08.7

out of the agency as of Tuesday, a government spokesman saying

1:12.7

this, Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration

1:18.3

and has decided to return to California and spend more time with his family, unquote. But some of the

1:24.7

press reports are suggesting that he was ousted and made controversies at the

1:29.7

agency. One of these involves a gene therapy for dushan muscular dystrophy. The company says that about

1:37.3

a thousand patients have been treated with it, but after two deaths, the FDA moved this month to halt

1:43.4

deliveries. And then on Monday, it seemed to have a change of heart.

1:47.0

Let's start with a clip of FDA Commissioner Marty McCarrie,

1:51.0

discussing this on CNBC.

1:53.0

That was a very temporary hold on the ambulatory population,

...

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