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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, according to an administration official.
Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, wants to spend more time with his family, the official said. The 46-year-old physician, millionaire venture capitalist and cancer survivor known for a self-assured, sometimes brash, manner lives in Westport, with his wife and three daughters – nine-year-old twins and a five-year-old.
A senior White House official said Gottlieb had spoken to the president, who 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, two officials said. The move came as a surprise to some FDA officials, because he has recently hired senior staff and was aggressively pushing a host of new initiatives.
The resignation comes 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 which have not yet emerged from the FDA, including proposals to ban menthol cigarettes and to reduce nicotine levels in cigarettes to “minimally addictive” levels.
In his resignation letter to Health and Human Services Secretary Alex Azar, Gottlieb, who took office in May 2017, 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 was a former top FDA official during the George W. Bush administration. When he was out of government, he 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 and inserted the agency into important health issues.
A frequent user of social media, Gottlieb from policy pronouncements to updates on the government shutdown to safe cooking tips. He raises chickens in his back yard and appeared on the cover of Backyard Poultry in the fall of 2017.
He spoke frequently about taking steps to combat escalating drug prices – venturing into an area that is 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.
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https://www.washingtonpost.com/health/2019/03/05/fda-commissioner-gottlieb-who-raised-alarms-about-teen-vaping-resigns/?utm_term=.32f68bb59ffd