Scott Gottlieb, MD, is resigning as FDA commissioner next month after less than two years in the position, Health and Human Services (HHS) Secretary Alex Azar II confirmed this afternoon.
Gottlieb’s tenure at the agency drew the most public attention for his public opposition to e-cigarettes and advocacy for policies to prevent opioid abuse. Yet his tenure also won praise within the biopharma industry because of the FDA’s rapid pace of reviews of new drug applications, and his willingness to criticize drug developers that sought to squelch competing drugs from reaching the market.
Last year the FDA approved a record-high 61 new drugs. Of these, 59 novel drugs won approval by the agency’s Center for Drug Evaluation and Research (CDER). The remaining two were recombinant therapies approved by the FDA’s Center for Biologics Evaluation and Research (CBER)—Portola Pharmaceuticals’ Andexxa® (Andexanet alfa) and Bayer’s Jivi® [antihemophilic factor (recombinant), PEGylated-aucl] lyophilized powder for solution.
“2018 stands out not only for the sheer volume of new drug approvals, but also for their quality, and the affirmation of several important trends that make it a watershed. It is also another signal that the innovation crisis that caused so much pain in the first decade of this millennium is now solidly behind us,” Bernard Munos, senior fellow at FasterCures, a center of the Milken Institute, wrote in a commentary published January 14 by Forbes.
According to the FDA’s website, the agency as of February 21 approved three novel drugs: Jeuvea® (prabotulinumtoxinA-xvfs), Cablivi® (caplacizumab-yhdp), and Egaten® (triclabendazole).
The resignation had not been sought by the administration of President Donald Trump, according to The Washington Post, which cited an unnamed administration official. Trump nominated Gottlieb in March 2017. Two months later, Gottlieb won U.S. Senate confirmation in a 57–42 vote largely along party lines.
CNBC reported that Gottlieb resigned in order to be closer to his wife and three daughters, who live in Westport, CT, citing unnamed people familiar with the commissioner.
Gottlieb rejoined the FDA from the American Enterprise Institute, a think tank which in part espouses free-enterprise approaches to policy issues, and where he was a resident fellow. He also held positions with two venture capital firms, T.R. Winston and New Enterprise Associates, after ending his first stint at the FDA, where he served as a deputy commissioner during the administration of George W. Bush.
“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,” Azar said in a statement.
“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” Azar added. “He 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.”