FDA chief Gottlieb steps down after nearly 2 years


WASHINGTON (AP) — Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency's response to a host of public health challenges, including the opioid epidemic, rising drug prices and underage vaping.

Health and Human Services Secretary Alex Azar announced in a statement today that Gottlieb would leave in a month. In a note to FDA staffers announcing his departure, Gottlieb cited "the challenge of being apart from my family" in Connecticut.

President Donald Trump tapped Gottlieb in 2017 to "cut red tape" at the FDA. But Gottlieb bucked expectations by pushing the agency to expand its authorities in several key ways, including an unprecedented effort to make cigarettes less addictive by requiring lower nicotine levels.

The 46-year-old physician and former conservative pundit advanced his agenda while managing to maintain the support of the president, Republicans and key Democrats in Congress.

Still, he departs with his most sweeping plans unfinished, including the initiative to make cigarettes less addictive.

In recent months, he came under fire for not acting more quickly to address an explosion in teenage use of electronic cigarettes, especially those with candy and fruit flavors. Under Gottlieb, the FDA has emphasized vaping as a potential tool to wean adult smokers off traditional cigarettes. And in a widely criticized move, Gottlieb delayed key regulations on vaping devices until 2022, in part, to avoid over-regulating the industry.

Anti-smoking groups are now suing the agency to begin reviewing e-cigarettes immediately as the most recent federal data suggest that 1 in 5 high school students are using e-cigarettes. While the FDA has taken steps to keep e-cigarettes away from teenagers, including tightening restrictions on convenience store sales, it's unclear whether they will be enough to reverse the trend.

The pushback against FDA's approach to vaping threatens to overshadow what is by far Gottlieb's most far-reaching plan. Gottlieb announced in May 2017 the FDA would seek to require tobacco companies to drastically cut nicotine in cigarettes, in a bid to help adult smokers quit.

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.

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