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Biden Still Hasn't Named A Leader For The FDA, Despite Its Importance In The Pandemic

LEILA FADEL, HOST:

As the Biden administration enters its 10th month, one of the most critical jobs on its public health team still hasn't been filled. There's no confirmed leader of the Food and Drug Administration despite its central role in responding to the challenges of the COVID pandemic. Here to explain what's going on is Rachana Pradhan, a reporter with Kaiser Health News who wrote recently about the FDA situation. Hi, Rachana.

RACHANA PRADHAN, BYLINE: Hi. Thank you for having me.

FADEL: So give us some context here. How unusual is it for a new administration to go this long without having a confirmed commissioner in place?

PRADHAN: It is pretty unusual. You'd have to go back about 20 years, to the start of the George W. Bush administration, to find a longer delay. For context, the Trump administration installed Scott Gottlieb within a few months. He was confirmed in early May 2017. And President Obama's first FDA commissioner, Margaret Hamburg, was in place by May 2009.

FADEL: And all those leaders weren't dealing with a global pandemic. Do we know if the administration has someone in mind to run the FDA?

PRADHAN: Well, for now, Dr. Janet Woodcock, who is a 30-plus-year veteran of the agency, has been serving as acting commissioner. But the president hasn't nominated her or anyone else for the permanent job.

And Dr. Woodcock has generated some opposition herself. When her name was floated, multiple Senate Democrats protested her potential nomination because of her time at the agency when opioids were approved. And she's also drawn complaints about the agency's approval of a controversial new Alzheimer's drug. So overall, a lot of criticism has been directed her way that she's too close to the pharmaceutical industry.

FADEL: Does it matter if there is an acting commissioner instead of one who's been confirmed by the Senate?

PRADHAN: Yes, it does in a lot of different ways. First of all, there's a time limit on how long an acting commissioner can serve. Second, almost more importantly, is that an acting commissioner just doesn't have as much power. They have less ability to chart a strategic course for the agency. And here we are in the middle of a pandemic with some of the most consequential decisions on vaccines, treatments, tests. They are all happening without a fully empowered leader at the helm of this agency.

The other thing that's really important, I think, to keep in mind is an acting commissioner is also just less accountable, usually to the public and also to lawmakers. That's why they really like to have someone who's confirmed in that position.

All of the public health experts and scientists I spoke with for my story were flabbergasted by how the administration has let this drag on this long. The FDA has a lot of responsibilities. Even other than the pandemic, which is a big enough of an issue to deal with, it regulates products that account for about 20 cents of every dollar that U.S. consumers spend.

FADEL: Wow.

PRADHAN: It has a lot of a responsibility.

FADEL: OK. So why the delay? And what happens next for the FDA and its leadership?

PRADHAN: Well, the clock is really ticking. Woodcock can only stay as acting commissioner until mid-November unless Biden formally nominates someone by then. And as to why this hasn't happened yet, no one can really say. Everyone I talked to was just confused, and they say they can't figure out the reason as to why this nomination has not occurred yet. But either way, something has to happen soon.

FADEL: That's Rachana Pradhan, a reporter with Kaiser Health News. Thank you so much for your reporting.

PRADHAN: Thank you so much. Transcript provided by NPR, Copyright NPR.