Food and Drug Commissioner Scott Gottlieb, who used his post to tackle difficult public health issues from youth vaping to opioid addiction – surprising early skeptics worried about his drug industry ties – resigned Tuesday, effective in about a month.

Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, said he wants to spend more time with his family. The 46-year-old physician, millionaire and cancer survivor known for a self-assured, sometimes brash, manner lives in Westport, with his wife and three daughters – 9-year-old twins and a 5-year-old.

“It was a very hard decision,” Gottlieb said in an interview. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends and come back to Washington on Sunday. I did the job 100 percent.”

The resignation was not sought by the White House. A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave. While Gottlieb had some policy disagreements with the White House, he is well respected, and could even be asked to take another post, said two officials. Gottlieb declined to comment on that possibility.

”…Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!” Trump tweeted around 4 p.m.

A Health and Human Services spokeswoman said no information was available on who might be named to assume his responsibilities on an acting or permanent basis.

The resignation took some senior FDA officials by surprise, and came as Gottlieb’s signature issue – youth vaping – is being reviewed by the White House Office of Management and Budget. The plan, detailed by Gottlieb last fall, would sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping, which he argues could lead to a whole new generation addicted to nicotine.

His initiative has won praise for shining a spotlight on a national problem. But it has also been criticized by some anti-tobacco activists as being too weak and by e-cigarette supporters as being too aggressive. Some libertarians and conservatives recently complained his approach represented “regulatory panic” and went against Trump’s anti-regulatory agenda.

The blueprint is expected to move forward, but Gottlieb’s departure could throw into question other controversial tobacco initiatives he championed that have not yet emerged from the FDA, including proposals to ban menthol cigarettes and to reduce nicotine levels in cigarettes to “minimally addictive” levels. The menthol ban, in particular, was opposed by Sen. Richard Burr of North Carolina, who put a hold on FDA legislation late last year to flag his concerns.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” Health and Human Services Secretary Alex Azar said in a statement. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. …The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

In his resignation letter to Azar, Gottlieb ticked off a list of accomplishments, including accelerating the approval of generic drugs and modernizing the process for handling novel gene and precision therapies to treat those with cancer and other dread diseases. He said the agency was “strong in moments of crisis,” including its work in Puerto Rico to remedy drug and medical device shortages after Hurricane Maria in 2017.

Gottlieb, who was a former top FDA official during the George W. Bush administration, also worked as a venture capitalist and consultant to drug and health-care companies. He stood out in the anti-regulatory Trump administration, where some officials such as Scott Pruitt, the former head of the Environmental Protection Agency, appeared intent on reducing the clout of the departments and agencies they headed. For nearly two years, Gottlieb has avidly promoted the FDA, inserting the agency into important health issues and sometimes taking on industries regulated by the agency.

A frequent user of social media, Gottlieb tweeted on everything from policy pronouncements to updates on the government shutdown to safe cooking tips.

He spoke often about taking steps to combat escalating drug prices – venturing into an area not traditionally regarded as part of the FDA’s portfolio – and pressed as a partial remedy faster generic-drug approvals to foster competition with pricey brand-name products. Last year, the agency approved a record 971 generic drugs. He also began posting lists of drugs that aren’t protected by patents, inviting applications from generic manufacturers, and sharply criticized brand-name companies for thwarting generic competition.

When Gottlieb’s name first came up as a candidate for FDA commissioner, some Democratic lawmakers worried he would be too close to the pharmaceutical industry. But as other names surfaced — including candidates pushed by Silicon Valley billionaire Peter Thiel who questioned whether the FDA should make companies prove their drugs are effective – Gottlieb appeared more moderate.

Gottlieb spent much of his confirmation hearing talking about the opioid epidemic – comparing it to public health emergencies caused by the Ebola and Zika viruses – while acknowledging the FDA’s own unwitting contribution by granting approvals for the painkillers. During his tenure, the FDA engineered the removal of the opioid medication Opana ER from the market, the first time the agency requested that action on public health grounds. But it also approved Dsuvia, a powerful new opioid over objections that it would cause more overdose deaths.

Robert Califf, who preceded Gottlieb as commissioner, said his successor did “a great job” and followed through on Obama administration efforts, such as encouraging the use of “real-world evidence” to augment clinical trials.

Ellen Sigal, chair of the nonprofit Friends of Cancer Research, said Gottlieb promoted innovation — for example, in pressing for new ways to develop and approve novel therapies made from living cells. “He understands the politics and bureaucracy of Washington – and he knows how to make that system work to benefit patients,” she said.

But Pieter Cohen, an associate professor at Harvard Medical School who conducts research into the safety of dietary supplements, faulted Gottlieb for not taking significant action on major safety problems involving dietary supplements. He said the agency should have pursued recalls of supplements adulterated with drugs such as steroids and acted against against new stimulants found in supplements.

“It’s disheartening, if you look at the last two years of the agency’s work with supplements,” Cohen said. “It’s inaction. It’s lack of forward motion. It’s maybe treading water.”

Last month, Gottlieb announced the agency had sent warnings to companies selling supplements containing unapproved drugs and making illegal claims for treating Alzheimer’s disease or other serious conditions.

Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, has sparred with Gottlieb on opioid policy. “I am concerned, because he seems to have a tendency to spend most of his time talking and very little of his time implementing policy.”

Gottlieb made his strongest public statements on tobacco. With 480,000 Americans dying every year from smoking-related causes, he frequently said curbing tobacco use was the No. 1 way to improve public health. His comments encouraged tobacco-control activists who said he had the potential to become the most important commissioner since David Kessler, who began efforts to regulate cigarettes as a drug in the 1990s.

In July 2017, a few months after becoming commissioner, Gottlieb unveiled a comprehensive tobacco blueprint calling for reduced nicotine levels in cigarettes. But he also delayed for several years a tough new regulation for e-cigarettes, delighting vaping interests and infuriating anti-tobacco groups and some Democratic lawmakers.

A little more than a year later, Gottlieb got new government data showing that vaping by minors was skyrocketing, fueled in large part by the popularity of JUUL Labs’ vaping products — sleek, high-nicotine e-cigarettes that resembled computer thumb drives and were available in popular flavors like mango.

By the fall of 2018, Gottlieb had changed course, calling teen vaping “an epidemic” and threatening vaping companies that he would pull their products off the market if they didn’t find a way to stop rampant use by minors. In November, he proposed limiting sales of most flavored e-cigarettes – except mint and menthol – to age-restricted stores, or parts of stores, and sharply tightening online purchases. And he said he wanted to ban menthol cigarettes and flavored cigars, as well as reduce nicotine levels.

Matthew Myers, president of Campaign for Tobacco-Free Kids, in a recent interview called the commissioner’s record on tobacco “complex and incomplete.” He said Gottlieb deserved credit for “shining a spotlight” on the rise of youth e-cigarette use and for aggressive enforcement actions against vaping companies that marketed to minors. But he said that Gottlieb’s decision in 2017 to delay the e-cigarette regulation itself contributed to the rise of youth vaping.

“His strong words have changed the public debate but until they are translated into enforceable rules, the epidemic will only grow worse,” he said.

From the other side, Gottlieb was pilloried by e-cigarette advocates who say his efforts to protect young people will make it more difficult for adult smokers to get the products they need to stop using regular cigarettes.

Gottlieb has said he doesn’t believe that he could have prevented the surge in youth vaping, given the popularity of JUUL and the lack of sufficient government data on the trend.

The FDA’s also took steps to rein in opioids. Gottlieb engineered the removal of the opioid medication Opana from the market in 2017 after the FDA concluded the “benefits of the drug may no longer outweigh its risks.” Its manufacturer, Endo Pharmaceuticals, had made the drug more difficult to crush and snort in 2012, but the FDA said that move actually led to more injections — and a major HIV outbreak.

The FDA’s most controversial opioid decision under Gottlieb probably came in November, when the agency approved Dsuvia, a powerful new fentanyl painkiller for use in health care settings, despite fears it would inevitably be diverted to the streets and cause more overdoses. The tiny 30-microgram pill, is five to 10 times more powerful than pharmaceutical fentanyl.

“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said at the time.

Gottlieb, acutely aware of the optics, used the moment to announce he would seek more authority for the agency to consider whether too many similar drugs are on the market, which might allow the agency to turn down future applications.

Just before stepping down, Gottlieb pledged to require drug companies to take another look at whether opioids are effective for chronic pain. That debate is a perennial flashpoint that will again place the FDA between public health authorities trying to tighten the supply of opioids and pain patients terrified they will not be able to get medication they need.

https://www.washingtonpost.com/health/2019/03/05/fda-commissioner-gottl…