Chapter 1: What significant event occurred with the FDA commissioner?
The Food and Drug Administration saw a huge shakeup in leadership today.
Today, the FDA commissioner, Dr. Marty McCary, resigned. And how big a deal is that? I think it's a huge deal.
Our colleague Liz Esley White covers health policy.
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.
President Trump called McCary, quote, a terrific guy, but added that he was having some difficulty. McCary, 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 McCary also faced a lot of headwinds throughout his tenure.
Patients, oncologists, and biotech investors have been pressing Commissioner McCary over a string of drug rejections, none more contentious than Replimune.
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.
I don't work for Replimune.
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Chapter 2: What controversies surrounded Dr. Marty McCary's tenure at the FDA?
I work for the American people, and I stand by the scientists at the FDA.
The White House has also blamed McCary for a mess of bad PR from people he brought on who then quickly left the agency. That's according to people familiar with the matter. The highest profile was Dr. Vinay Prasad, who was hired, fired, and then rehired as the FDA's vaccine chief. Prasad ultimately stepped down in March.
Beyond the personnel issues, McCary has also been criticized for not moving fast enough on issues important to the GOP.
He has been targeted by anti-abortion advocates who called for his resignation after he promised a review of the safety of the abortion pill and has not produced it. But the vaping argument is what really catalyzed The movement towards, let's go ahead and pull the plug here.
Why, of all things, vaping? Why was this the thing that caught the president's attention?
Well, the president made a commitment to the vaping industry in his 2024 presidential campaign. He ran on a platform of Let's Save Vaping. His advisors had identified that constituency as important to his base. They viewed it as a way to reach young MAGA voters. There were a lot of factors that led to this moment, but the vaping situation seems to have been an accelerant on the firestorm here.
It is what seems to have sped up his ouster.
McCary didn't respond to requests for comment. Welcome to The Journal, our show about money, business, and power. I'm Jessica Mendoza. It's Tuesday, May 12th. Coming up on the show, the vaping firestorm that ousted the FDA commissioner.
We have a problem in our country. It's a new problem. It's a problem that nobody really thought about too much a few years ago, and it's called vaping.
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Chapter 3: How did flavored vapes become a focal point in McCary's resignation?
And then how did we get from the approval of the glass application to McCary potentially getting fired?
We knew going into that weekend where Trump got upset about vaping that there were already people in the vaping industry and the pharmaceutical industry who had become so upset about certain actions that McCary had taken that they were already willing to call for his firing. They wanted him out.
It appears that there were enough concerns inside the administration that officials did come up with this plan to oust McCary and got the initial sign-off from Trump.
The news about McCary's potential firing overshadowed another significant change on nicotine products, which the FDA announced last Friday.
We had a big policy announcement from the FDA that said, hey, tobacco industry, if you have an electronic nicotine product or a pouch product that you've already filed an application for, you can go ahead and market it, and we're not going to enforce against that. We're not going to come after you, basically. So even while you're waiting for our official pre-market approval...
you can move ahead with selling these products. And industry experts think this is going to be a flood of new products in coming months. Wow.
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Chapter 4: What role did President Trump's stance on vaping play in McCary's ouster?
So essentially, vaping products that are waiting for FDA approval can now go on the market. Seems like a pretty big shift.
Yeah, it's a big shift. You know, they're saying, well, this is not a guarantee of authorization. The stated intention of the policy is to move the market from a, you know, dominated by unregulated Chinese vapes to a more regulated market where most of what you see in the vape shop is stuff that the FDA has signed off on.
It is clear that this was a response to the frustration that President Trump exhibited on this issue the other weekend. They were, you know, moving quickly to try to carry out this aim of the Trump administration in a way that they had not previously done. And what about public health experts? What have they said about this policy change? Depending on where you sit, that could be a good thing.
That could help smokers who want to quit. Or it could be a really bad thing. It could introduce people to nicotine addiction who didn't need to be addicted.
And I talked to a former tobacco regulator at the FDA, Mitch Zeller, and he is very concerned about the substance of the policy because it's allowing all these products that have not been scientifically authorized by the FDA onto the market in a way that is not the intent of the law. And that's very concerning because
now people will be potentially able to get products where the risks might outweigh the benefits. So he's very worried. And in addition, we have seen, you know, some vape retailers express assurance that there would be a lot more products coming their way. So according to Mitch Zeller, that could mean hundreds, thousands, or tens of thousands new products in the coming months.
With McCary out, the White House has appointed Kyle Diamantis as the acting FDA commissioner. Diamantis is an attorney who'd been in charge of the agency's food division.
He's actually proven quite popular with FDA staff. He's known as a level-headed operator.
And what do you think the administration will be looking for in whoever runs the FDA next?
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