WASHINGTON — Scott Gottlieb, the commissioner of the Food and Drug Administration, known for his aggressive efforts to regulate the tobacco and e-cigarette industries, said on Tuesday that he would resign at the end of the month.
The reason he gave was family and his weariness with commuting to see his wife and three children, who have remained in their Westport, Conn. home since he took office. But his announcement caught many in Washington and the industries he regulates by surprise and raised questions about whether his push to reduce teenage vaping and lower nicotine levels and ban menthol in cigarettes will continue in an administration that generally has a hands-off approach to business.
“It’s critical that his successor champions protecting kids and the rest of the nation against the tobacco epidemic,” said Cliff Douglas, vice president of tobacco control at the American Cancer Society. “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. Gottlieb has been subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes. A coalition of influential conservative groups recently asked the White House to block some key parts of the F.D.A.’s strategy to prevent youths from vaping. Republican Senator Richard Burr blasted the commissioner on the Senate floor for his proposal to ban menthol cigarettes.
Dr. Gottlieb said these protests had no role in his departure.
“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.
Dr. Gottlieb said he planned to advance the F.D.A.’s pending tobacco regulations before he leaves. And he was confident, he said, that the agency’s guidance on restricting flavored e-cigarettes would be issued before he left. He acknowledged, however, that he could not predict the fate of his proposals to ban menthol in cigarettes and reduce nicotine to nonaddictive levels in cigarettes.
Industry analysts expressed optimism that those initiatives would, in fact, now end.
“We think this major development will be broadly viewed as a positive for the tobacco industry, although this introduces some uncertainty,” Bonnie Herzog, a managing director of equity research at Wells Fargo Securities, wrote in an email to clients. “We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives.”
When he was first nominated, Dr. Gottlieb seemed a figure right out of central casting for the Trump administration. As a venture capitalist who served as both a consultant and board member for drug companies, he had made a fortune from the industry he would regulate, written impassioned anti-regulatory columns in conservative journals, and held stock in industry players large and small, which he divested. But he was also a physician, and as he settled into the job, his libertarian views were often balanced by his zeal to protect public health.
“He was remarkably successful at keeping the agency moving forward at a difficult time and really focused on public health challenges, including the opioid epidemic and drug prices, “ said Dr. Joshua M. Sharfstein, a former principal deputy commissioner at the F.D.A. during the Obama administration, who is now a professor of health policy at the Johns Hopkins Bloomberg School of Public Health. “He surprised a lot of people in his willingness to take some risks for public health.”
Under Dr. Gottlieb’s leadership, the F.D.A. approved a record number of generic medicines, new drugs, and medical devices. He led the agency into unusual territory, calling for lower drug prices and speaking out about the opioid crisis.
But his record on opioids was mixed, some policy experts said. Although the agency worked to take one powerful addictive painkiller, Opana ER, off the market, it approved Dsuvia, a new form of an extremely potent opioid, for acute pain — which public health advocates feared would be just as dangerous.
Ryan Hampton, who advocates for people recovering from addictions and who has testified before Congress, recently helped launch a campaign, “Wake Up F.D.A.,” to protest the agency’s approval of Dsuvia, while being slow to approve new medications to treat addiction, though Dr. Gottlieb spoke often about the importance of doing so.
“The ideal response would be not to bring more dangerous opioids to the market in the midst of a public health crisis,” Mr. Hampton said of the F.D.A. under Dr. Gottlieb. “That was a huge red flag and lapse in judgment on Gottlieb’s part. Once that happened, folks in the recovery community lost confidence in Gottlieb and the F.D.A.”
Likewise, the F.D.A.’s speedy approval of many medical devices was praised by the growing industry, but has drawn strong protests from many people who believe the rate of approval has been too rapid to ensure safety. He also worked to better track outbreaks of food-borne illness, and to boost new treatments like gene therapy and targeted medicine.
During his tenure at the F.D.A., Dr. Gottlieb, who was not shy about announcing his achievements, sometimes several times a day on social media, eventually moved from a hands-off approach to the nascent e-cigarette companies, to leading a clamorous fight against them, particularly as studies emerged about how teenagers swarmed the new product, unaware of the addictive properties of nicotine.
In shifting his position, from giving the companies years to show that e-cigarettes were both safe and effective for smoking cessation, to urging stringent monitoring of convenience stores, vaping flavors and age restrictions, Dr. Gottlieb earned both the umbrage of pro-business leaders and some aspersions from the antismoking movement, which felt he moved too slowly.
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, acknowledged that Dr. Gottlieb walked a tightrope, leaving a complex record in his wake. “He has made proposals that had the potential to reduce tobacco use more dramatically than any other federal public official in U.S. history,” Mr. Myers said. “On e-cigarettes he deserves enormous credit for shining a spotlight on the crisis of its use by kids.”
“But,” Mr. Myers continued, “the fact that he has not prohibited the marketing of the flavored products outright has contributed to the problem. His legacy will depend upon whether his proposals, including those for e-cigarettes, ultimately become law.”
And the landmark tobacco regulation plan, announced in July 2017, has lagged in some important areas. After the tobacco industry sent thousands of letters against reducing nicotine in cigarettes to nonaddictive levels, that plan has stalled. The proposal to eliminate menthol in cigarettes has not yet been formalized. Dr. Gottlieb’s early decision to give e-cigarette companies more time to comply with new, tougher regulations is viewed by many as having opened the door to the youth vaping epidemic.
