FDA Commissioner Scott Gottlieb Resigning

Alicia Ault

March 05, 2019

Scott Gottlieb, MD, is resigning from his position as commissioner of the US Food and Drug Administration (FDA), effective April 5, according to a statement issued by the Health and Human Services department (HHS).

Gottlieb, who was sworn in on May 11, 2017, has been an activist commissioner, despite initial misgivings that he would be too industry-friendly given his past ties to drug and device companies.

The FDA chief has focused much of his energy on regulating e-cigarettes, calling vaping a scourge among American teenagers. Gottlieb announced yesterday that the agency was going after retailers that had repeatedly illegally sold e-cigarettes to minors.

He has also attacked the high cost of pharmaceuticals, advocating agency policies to help bring down those prices, and has overseen the issuance of long-awaited regulations and policies, such as the recent rule aimed at addressing the safety of sunscreens and how they are manufactured and labeled.

HHS Secretary Alex Azar issued a statement praising Gottlieb’s tenure. "Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more," said Azar.

Gottlieb has not said where he will go next, but he had previously held positions within FDA and at the Centers for Medicare & Medicaid Services, and also was a research fellow at the American Enterprise Institute. He was also a clinical assistant professor at the New York University School of Medicine in New York City, where he practiced as a hospitalist.

Before being nominated by President Donald J. Trump in March 2017 to head the FDA, Gottlieb had also been an active consultant with pharmaceutical and medical device companies, including GlaxoSmithKline, Glytec, and Tolero Pharmaceuticals. He also was heavily invested in healthcare stocks, which he had to divest before taking the commissioner position.

Azar said that Gottlieb "has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family."

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