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The Vape Cloud Hanging Over the FDA

5/12/202621 min

Dr. Marty Makary has resigned as commissioner of the Food and Drug Administration. Makary faced criticism over the FDA’s rejections of rare-disease drugs, the agency’s handling of abortion pills and high-profile departures of key FDA staff. But WSJ’s Liz Essley Whyte reports that it was a battle over flavored vapes that sealed Makary’s fate. Jessica Mendoza hosts. Further Listening:

  • The Flu Shot Drama at the FDA
  • The FDA Boss on the Agency’s MAHA Makeover - How Puff Bar Became the Most Popular Vape for KidsSign up for WSJ’s free What’s News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices

Clips

Transcript preview

First 90 seconds
  1. Jessica Mendoza· Host0:00

    [upbeat music] The Food and Drug Administration saw a huge shakeup in leadership today.

  2. Liz Essley Whyte· Guest0:09

    Today, the FDA commissioner, Dr. Marty Makary, resigned.

  3. Jessica Mendoza· Host0:14

    And how big a deal is that?

  4. Liz Essley Whyte· Guest0:17

    I think it's a huge deal.

  5. Jessica Mendoza· Host0:20

    Our colleague, Liz Esley White, covers health policy.

  6. Liz Essley Whyte· Guest0:23

    He had a tumultuous tenure full of intrigue, and palace drama, and politics, and conflict in a way that we haven't really seen with any other FDA commissioner.

  7. Jessica Mendoza· Host0:37

    President Trump called Makary, quote, "A terrific guy," but added that he was having some difficulty. [upbeat music] Makary, a surgeon by training, was sworn in as commissioner over a year ago, with promises to usher in a new era at the FDA. He started phasing out artificial food dyes, and cut down on the time it takes for drugs to get FDA approval. But Makary also faced a lot of headwinds throughout his tenure.

  8. Speaker 21:04

    Patients, oncologists, and biotech investors have been pressing Commissioner Makary over a string of drug rejections. None more contentious than REPLIMUNE. That's a- He's managed to make a lot of critics in the pharmaceutical industry, who view him as unsympathetic to the cause of rare disease patients.

  9. Marty Makary· Soundbite1:23

    Uh, I don't work for REPLIMUNE, I work for the American people, and I stand by the scientists at the FDA.

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