AUDIE CORNISH, HOST:
The head of the Food and Drug Administration is resigning. Dr. Scott Gottlieb said in a letter to Health and Human Services secretary Alex Azar that he will step down in a month. The announcement surprised industry leaders and public health officials. At this point, it's unclear why Gottlieb resigned or who will replace him.
NPR's Alison Kodjak is on the line to take stock of Gottlieb's tenure at the FDA. And first of all, Alison, just give us a little background on Gottlieb - right? - not someone people have heard that much about.
ALISON KODJAK, BYLINE: No, he's not a household name, but he's had a lot of influence as leader of the FDA. And for a lot of people, he's been a pretty pleasant surprise. He's a doctor. He worked originally in the Bush administration. He's young. He's personable. He's very active on Twitter, and he's been known for wearing interesting socks, including a pair with a skull and crossbones that he gets photographed in quite a lot.
Before joining the Trump administration, though, he worked in biotech and pharmaceutical industry - an executive and a consultant - and he made an awful lot of money. So a lot of critics worry that at a time when drug prices are such a big issue, he'd take a hands-off approach to drug companies and to regulation. But he actually did the opposite. He took on some major companies and industries in his role.
CORNISH: Right. As head of the FDA, he also led this campaign against e-cigarette use by teens. Can you talk about what he did with that?
KODJAK: Yeah, that was one of his biggest campaigns. He said last year that teens using the Juul brand of e-cigarettes was - had reached an epidemic proportions. He repeated that in a statement just yesterday. And you know, he is requiring Juul and some other companies to lay out detailed plans about how they're going to reduce teen vaping. And he yesterday just sent a letter to Walgreens, another big company, asking for a meeting because he says they've racked up so many violations for illegally selling tobacco products to kids. And he went on to even name other national chain stores that have been cited for selling to kids. So he's proven that he's not afraid to make big companies angry.
CORNISH: Another issue we've heard about from this White House is prescription drugs. And that's a big part of the FDA's mandate, right?
KODJAK: Yeah, they approve both prescription - brand name and generic prescription drugs. And Dr. Gottlieb - a lot of people were suspicious of him when he was appointed, but he's been very vocal about high - how high drug prices are out of line, and he's looking for ways to bring them down. He's a Republican, so he's been advocating for market solutions. And he doesn't really have authority over pricing, but under his leadership, the FDA did manage to approve more generic drugs in the last two years than ever before. He wrote new rules that would streamline this whole process.
But he's also taken another step. He's been calling out drug company tactics that are trying to keep competition out, mostly one where companies - brand name companies block generic competition by not letting them have access to their medications so they can make copies. Last year, he did a speech where he famously warned companies to, quote, "stop the shenanigans." And then again, he published a list of the companies that were accused of doing this. He's sort of on a name and shame campaign.
CORNISH: And there was some controversy last year when it approved a new opioid. What went out? What happened?
KODJAK: Yeah, the FDA approved this opioid called Dsuvia. It's incredibly potent, and a lot of people really didn't want to see it on the market. But Dr. Gottlieb - he defended it by saying it was the best choice available under certain circumstances. But at the same time, he opened up a discussion about whether the FDA should look at things other than the effectiveness of a drug and its approval. So you know, he took on - he took a controversial action, but he also didn't shy away from that controversy.
CORNISH: That's NPR's Alison Kodjak. Alison, thank you.
KODJAK: Thank you. Transcript provided by NPR, Copyright NPR.
