Column: Scott Gottlieb, who won praise for trying to do his regulatory job, is quitting the FDA

It’s perhaps inevitable that a federal regulator who has acquired a reputation for doing his job effectively will be a short-timer in the Trump administration. That’s the case with Scott Gottlieb, who on Tuesday announced that he will leave his post as head of the Food and Drug Administration next month.

Gottlieb, 46, will have lasted less than two years as FDA commissioner. Beyond saying that he wished to spend more time with his family, which had stayed home in Westport, Conn., while he commuted to Washington, he gave no explanation for his sudden resignation. His announcement comes only two months after he debunked rumors of his impending departure. “I want to be very clear — I’m not leaving,” he wrote on Twitter on Jan. 3.

As recently as Tuesday morning, Gottlieb appeared on CNBC to announce a crackdown on 15 national retailers for selling tobacco and e-cigarettes to minors, giving no clue about the announcement he was to make a few hours later. There were no indications that he was pressured to resign; in fact, his image as an effective regulator was one of the few examples of functioning government that Trump could point to.

Gottlieb’s appointment in March 2017 raised concerns among healthcare advocates because of his ties to the pharmaceutical industry, in which he has been a millionaire investor.

“He was entangled in an unprecedented web of ties to Big Pharma,” says Michael Carome, director of the Health Research Group at Public Citizen, which opposed his confirmation. He was labeled “a bona-fide pharma shill” whose appointment was greeted with unalloyed joy by the drug industry. But even some healthcare advocates were relieved that Gottlieb got the job over such candidates as Peter Thiel, a Silicon Valley billionaire with an extreme anti-regulatory bent.

In office, Gottlieb won positive reviews for some of his regulatory initiatives on public health issues such as opioid abuse, the rise of vaping among underage users, and clinics hawking bogus stem cell “cures” for incurable diseases. He had pledged to streamline the FDA process for approving drugs, which brought him praise from some patient advocates.

The FDA’s more permissive approach on drug approvals was cited Tuesday by President Trump, who tweeted his appreciation for Gottlieb’s efforts “to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things.”

But critics fault Gottlieb for pushing the FDA too far in favor of hasty approvals of drugs and medical devices and failing to support the agency’s other public health initiatives with more than lip service.

“We’re not sad to see him go,” Public Citizen’s Carome told me.

Under Gottlieb, for example, the FDA abandoned efforts last year to require more clinical trial evidence for the safety of baricitinib, a controversial drug for rheumatoid arthritis marketed by Eli Lilly & Co. as Olumiant. Although the FDA had rejected the drug in 2017 because of reports that it promoted life-threatening blood clots, the agency approved the drug in June.

Critics say that Gottlieb’s initiatives against opioid abuse, which he termed “the biggest public health crisis facing the FDA,” were undermined by the agency’s approval of a new opioid drug thought to be unusually vulnerable to diversion from healthcare clinics to the black market.

The drug is Dsuvia, which is a dangerously potent but slow-acting painkiller that is being marketed as a small pill to place under the tongue. The FDA approved its marketing in November over the objection of Raeford Brown, chair of the agency’s Anesthetic and Analgesic Drug Products Committee.

In a letter to Gottlieb, Brown called Dsuvia “an extremely divertible drug,” and added: “I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market.”

As for stem cell clinics, Gottlieb’s FDA launched a crackdown on some questionable clinics and even threatened to shut them down, but experts concerned about the hawking of unproven “cures” sold to desperate patients for thousands of dollars per supposed treatment have been waiting for more concerted action.

The greatest concern among healthcare advocates may turn on what lies ahead for the FDA. “It’s imperative that the next nominee be free of industry ties,” Carome says. But that isn’t the Trump administration’s typical approach to regulatory agencies.

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