The Atlanta Journal-Constitution

FDA COMMISSION­ER DECIDES TO STEP DOWN

Food and Drug Commission­er Scott Gottlieb, who used his post to tackle difficult public health issues from youth vaping to opioid addiction, resigned Tuesday, effective in about a month, according to an administra­tion official.

- By Laurie McGinley and Lenny Bernstein

Who is he?

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.

President Donald Trump selected Gottlieb in 2017 to “cut red tape” at the FDA. But Gottlieb bucked expectatio­ns by pushing the agency to expand its authority. On one key issue, he targeted drug industry tactics used to maintain sky-high prices on older drugs, calling them “shenanigan­s” and “deceptions.” FDA commission­ers have steered clear of the issue, noting the agency has no direct role in regulating U.S. medicine prices, which are set by drugmakers.

What did he do about vaping?

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.

What’s next?

The blueprint on vaping 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 mentholcig­arettes and to reduce nicotine levels in cigarettes to “minimally addictive” levels.

The agency has had the authority to regulate nicotine levels since 2009, though no previous FDA commission­er tried to use it. The agency is still in the early stages of writing regulation­s that would standardiz­e nicotine in cigarettes.

 ?? ABACA PRESS ?? FDA Commission­er Scott Gottlieb proposed to sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping.
ABACA PRESS FDA Commission­er Scott Gottlieb proposed to sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping.

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