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FDA Chief Scott Gottlieb Abruptly Resigns

Mar 6, 2019
FDA Chief Scott Gottlieb Abruptly Resigns
Scott Gottlieb at a nomination hearing in April 2017.
Image: Zach Gibson (Getty Images)

In what might be one of the most surprising departures from the Trump administration yet, Scott Gottlieb has tendered his resignation as commissioner of the Food and Drug Administration, effective next month. The abrupt decision, initially reported by the Washington Post on Tuesday, comes in the middle of several public health initiatives pushed by Gottlieb's FDA, most prominently its crusade against teen vaping.

According to the Washington Post's sources, the 46-year-old Gottlieb decided to resign to spend more time with his wife and three daughters, who reside in Connecticut. He is said to have sent his resignation letter to Health and Human Services Secretary Alex Azar, whose agency oversees the FDA. He also spoke with President Trump about his decision, who reportedly expressed regret about his departure.

In a statement shared from the FDA Twitter account, Gottlieb said, "There's perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children."

Gottlieb's sudden exit is especially notable because he had been one of the least controversial--and one of the most competent--appointments made by the Trump White House.

Prior to stepping into the position in May 2017, critics pointed to the physician's long history with the pharmaceutical industry as a disqualifying factor. Some also worried that Gottlieb would systematically undermine the regulatory power of the agency, similar to how other Trump appointees have gutted regulations at the EPA and elsewhere. But Gottlieb's FDA career, while certainly not perfect, has largely avoided any political overtones or major disasters.

Under his tenure, the agency pursued efforts to drive down drug prices by encouraging the development of more generic drugs and shaming drug companies that attempted to block generics (he, like others in the Trump White House, resisted more aggressive measures, however). Gottlieb also consistently advocated for evidence-based approaches to public health issues, including the opioid crisis. In particular, he stressed the need for greater access to medication-assisted treatment for people living with opioid use disorder, and expanded the agency's ability to consider new treatments for approval. Notably, Gottlieb was never accused of lying about his research, bilking the public for expensive flights, or trashing people's homes, unlike certain other Trump appointees.

That said, Gottlieb's FDA has earned its fair share of criticism. Some doctors have argued that the agency has done little to effectively regulate the supplement industry, a longstanding complaint (though in February, the FDA did announce it would significantly overhaul its oversight of supplements). Gottlieb also took fire for his agency's decision to approve Dsuvia, the tablet form of an opioid painkiller more potent than fentanyl. He was also criticized for pushing back the timetable for when new regulatory rules would apply to e-cigarette products, similar to how tobacco cigarettes are regulated. Initially, the process would have started in 2018, but Gottlieb delayed it until 2022--a decision that prompted a lawsuit against the agency by several major public health groups, including the American Heart Association.

Gottlieb and the FDA eventually took a far harsher stance on vaping, purportedly because of new data showing that teens were using newer e-cigarette products like Juul pods at alarmingly higher rates than before. Just this past weekend, Gottlieb reportedly went to the White House to push for a policy that would effectively ban the sale of flavored e-cigarette products in non-speciality stores, along with other measures to prevent teen use. Gottlieb has also called teen vaping one of the agency's greatest public health challenges.

What will become of the anti-vaping initiative and others advanced by Gottlieb is something that's now up in the air, though. And perhaps equally worrying is the question of who exactly will replace the actually decent Gottlieb.