Amna Nawaz:

Multiple outlets are reporting that President Trump is set to fire the commissioner of the Food and Drug Administration, Marty Makary.

While that hasn't happened at this hour, all of this comes after a tumultuous tenure since his installment as FDA head last year.

Stephanie Sy has our look.

Stephanie Sy:

Amna, Dr. Makary, a Make America Healthy Again advocate, has faced broad criticism from the White House, as well as pharmaceutical industry groups, over his handling of the agency that oversees drug and vaccine approvals.

He's also been accused of confusion at the agency and was recently the target of criticism from anti-abortion groups for not restricting access to mifepristone, a medication used for abortions. This has all raised a lot of questions about the turmoil and the political pressure within this agency.

Liz Whyte, who covers health policy at The Wall Street Journal, joins me now with more.

Liz, a lot of media outlets are reporting this firing plan, but you broke the story. You have written about the criticism, the pressure Makary has been facing from different angles. In your reporting, are you seeing a sort of straw that broke the camel's back here? With the caveat, of course, that the president could still change his mind.

Liz Essley Whyte, The Wall Street Journal:

Yes, we know a lot of the frustration with Makary's leadership has been building over time.

But we also know that, this past weekend, the president himself grew quite frustrated that he felt Marty Makary was slow-walking his agenda on flavored vapes. And he made that frustration known. And we saw Tuesday that, for the first time in years, the FDA approved blueberry- and mango-flavored vapes.

And they have taken a number of other tobacco-related actions since then. And we also know that, in addition, the complaints from pharmaceutical companies were also something that White House officials had in mind as they considered whether to talk to Trump about this.

Stephanie Sy:

Going back to the vape issue for a second, we should remind viewers that President Trump in his second term pledged to save vaping. So that certainly could have been a factor.

But there's also been criticism you have written about that characterizes the FDA as overall dysfunctional under his leadership. So describe, Liz, what was going on and what was he navigating within the agency?

Liz Essley Whyte:

Yes, the commissioner has increasingly -- increasingly relied on a small inner circle of advisers to run the agency.

He has had multiple series of conflicts with HHS and has had some conflicts with the White House as well, that we reported today that White House officials increasingly began to see him as a rogue agent, kind of marching to the beat of his own drum.

And all of those things kept piling up. It was an issue even last year. HHS Secretary Robert F. Kennedy Jr. at that point had considered making Marty Makary a figurehead at the FDA and installing someone else to run the day-to-day of the agency because he was worried about his management.

They backed off of that plan, but it seems that the concerns just didn't go away.

Stephanie Sy:

And you also have, as you referenced, the pharmaceutical industry unhappy with the pace of innovative drug approvals, the pace of clinical trial approvals that they have accused the Trump administration and the FDA as shipping over to China in favor of more accelerated trials.

So talk about the influence of this pharmaceutical industry in this potential decision.

Liz Essley Whyte:

Yes, the commissioner has pledged to speed up a lot of those bureaucratic red tape things at the FDA. He talks a lot about that, actually.

What some pharmaceutical companies, especially some smaller biotechs that have rare disease drugs, have been really upset about in recent weeks and months, though, is this series of regulatory U-turns, where they feel like they got encouraging signs and green lights from the FDA, and thus they invested a lot more in their drug development programs, and then were met with out of the blue rejections or other negative things from the FDA that ended up costing them a lot of money.

And the thought was that a lot of that was tied to Dr. Vinay Prasad, a guy that Marty had -- Dr. Marty Makary had hired to run the Vaccines Division at FDA. But he's gone, and the complaints are still mounting.

And so now those companies have started to complain about Dr. Marty Makary himself.

Stephanie Sy:

Then there's this issue of mifepristone, which we have been covering a lot on this program, in particular, that the health secretary had ordered a review of the safety of this medication used by women for medical abortions.

They did not, that review, lead to the restrictions that anti-abortion activists had hoped for. So, Liz, when you think about Makary's tenure and this reported plan to fire him, did he have ultimately a hard time balancing politics with his role?

Liz Essley Whyte:

Yes, I mean, he definitely didn't know how to dodge these complaints.

He made explicit promises to produce this review in his early days as FDA commissioner. But he never did. And he was telling people inside the administration he needed a new data system to make this happen, a data system that won't be up and running until, the earliest, end of this year or early next, which is not a timeline that anti-abortion advocates wanted to hear.

In addition, he approved a generic form of mifepristone, the abortion pill. And that really upset anti-abortion groups. He told people that he had to legally, but he told us and we reported this that he could have slow-walked it and didn't.

Stephanie Sy:

Finally, what can we expect next? Major changes at the FDA?

Liz Essley Whyte:

Yes, we reported that the president signed off on a plan to fire Makary. Obviously, the president changes his mind. And so we'd be looking to see if that gets announced in the coming days.

The White House officials will need to land on an acting official to lead the agency. There are a couple names that have already been floated for that. And then they will have to come up with a new nominee at the same time as they are putting forward nominees for CDC and surgeon general.

So it'll be a big, heavy lift to get those health nominees through the Senate this year.

Stephanie Sy:

That is Liz Whyte joining us from The Wall Street Journal.

Liz, thank you.

Liz Essley Whyte:

Thanks for having me.