US FDA chief tough on e-cigs steps down in surprise resignation

Roman Schwartz
March 8, 2019

Food and Drug Administration Commissioner Scott Gottlieb, who oversaw federal efforts to tackle abuse of opioids and reverse an explosion in teen vaping, resigned Tuesday, depriving President Trump of a steady hand in a Cabinet that has seen plenty of upheaval.

The Biosimilars Forum, also in an email to The Center for Biosimilars, said that "Commissioner Gottlieb has shown strong leadership in both his words and actions to increase access to biosimilars and bring real savings to the U.S. healthcare system..."

Some Democrats thought his attempt to preserve access to flavors for adult smokers would leave open many avenues to youth vaping.

The departure raises questions about whether the agency would continue to vigorously seek to curb the exploding use of e-cigarettes among young people, among other Gottlieb initiatives. Shehan said that Gottlieb's tenure at the FDA compared with those of previous commissioners has been "a pretty stark contrast" in terms of "what he's done and been willing to do to make the drug market more competitive".

Barclays also agreed that any new FDA commissioner "has to tackle the alarming rise in e-cigs youth use", adding that flavour bans on e-cigs cigars are "still very likely". "Gottlieb has taken historic steps to take on this epidemic in a new way, including such proposals as reducing nicotine in cigarettes to nonaddictive levels and now pursuing a potential ban on menthol in cigarettes, so it is critical that whoever succeeds him picks up that mantel and treats it with equal priority that he has given it".

Dr. Peter Lurie, a former senior FDA official under President Barack Obama, said Gottlieb embraced the agency's regulatory powers where other Trump appointees tried to weaken their agencies.

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Elsewhere, Gottlieb targeted drug industry tactics used to maintain sky-high prices on older drugs, calling them "shenanigans" and "deceptions".

As for who might be Gottlieb's replacement, no names have circulated broadly, although Politico reported that National Cancer Institute Director Norman Sharpless, MD; Amy Abernethy, MD, PhD, FDA's principal deputy commissioner; and Health and Human Services Assistant Secretary for Health Adm. Brett Giroir, MD, had been floated as possibilities. "He and his talents will be greatly missed!" the president tweeted. It's not yet clear whether that effort has reduced drug abuse or overdose rates.

On FDA's more day-to-day responsibilities, Gottlieb continued a multi-decade, bipartisan shift toward faster, more streamlined product reviews for drugs and medical devices.

Under his watch, approvals for totally new drugs soared to 59 in 2018 from just 22 in 2016, the previous year of the Obama administration.

Gottlieb has always been a favorite of the industry, due to his focus on cutting unnecessary regulations and speeding product approvals. After leaving the FDA in 2007, he joined venture capital firm New Enterprise Associates as a member of its healthcare investment team.

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