Two months after tamping down speculation that he would leave the agency and promising a roadmap for 2019, Food and Drug Administration Commissioner Scott Gottlieb has resigned, The Washington Post reported Tuesday.
Citing an unnamed FDA official, the newspaper reported that Gottlieb, 46, had been commuting weekly between his home in Westport, Connecticut, and Washington and wanted to spend more time with his family. The FDA’s offices are in Silver Spring, Maryland.
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“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” Health and Human Services Secretary Alex Azar wrote in a statement. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”
Gottlieb’s tenure also got high marks from other individuals and organizations in healthcare.
“He clearly was capable and aggressive in taking a look at the major challenges we’re facing in healthcare,” said Medical Alley Association CEO Shaye Mandle, in a phone interview. “We’re hopeful that the next commissioner will see the progress of that work and continue to move along that path.”
Drug industry trade group the Pharmaceutical Research and Manufacturers of America also praised his work at the agency. “During his tenure, he focused on innovation in drug development and review, increased competition, and advanced the regulatory framework for approving novel technologies, including gene therapies,” an emailed statement from PhRMA read. “His efforts have made a meaningful impact for patients in need of innovative medicines.”
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Mike Pellini, former CEO of Foundation Medicine and now managing partner of venture capital firm Section 32, also had a positive view of Gottlieb’s tenure. “On the one hand, Dr. Gottlieb’s resignation is a big loss for the broader healthcare community and industry,” he wrote in an emailed statement. “But at the same time, we’re fortunate to have Dr. Amy Abernathy already on board with the FDA. I wish Scott and his family the best.”
Gottlieb was also seen as having a positive effect on digital health. “Scott’s resignation is a huge loss to the FDA, and to the digital health community,” wrote Sean Duffy, CEO of Omada Health, in an email. “Gottlieb and his team have pushed the agency to make great strides in how they interact with, and regulate, digital health companies. While I’m confident the leaders he empowered will carry on that work, and we wish Scott the best, there’s no doubt he’ll be missed and hard to replace.”
Rumors surfaced in January that Gottlieb would be leaving the agency, but he denied it in a tweet at the time. In keeping with his sense of humor, the tweet included a graphic of Mark Twain with the author’s famous quotation, “The reports of my death have been greatly exaggerated.”
Gottlieb, who is also a Hodgkin’s lymphoma survivor, was sworn in as the agency’s 23rd commissioner on May 11, 2017. He previously served as its deputy commissioner for medical and scientific affairs and as an adviser to the commissioner during the Bush administration. After leaving the FDA in 2007, he joined venture capital firm New Enterprise Associates as a member of its healthcare investment team. He also did consulting work for drugmakers like Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi Sankyo and Novo Nordisk, among others.
His ties with drugmakers, for which he collected millions of dollars, raised concerns among many that he would be too friendly to the industry. Nevertheless, he has played an active role in promoting competition, particularly in the area of generics and biosimilars, and had planned for the agency to be especially active in that regard this year. While the FDA does not have a mandate to address the issue of drug prices, Gottlieb promoted competition as a way for the agency to play a more active role.
Last year, the agency created a web page naming pharmaceutical companies that have been the subject of complaints from generic drugmakers for making it difficult for the latter to obtain samples so they can develop competitor products. Other actions have included an initiative with the Patent and Trademark Office to look closely at the Orange Book – which lists patent and exclusivity information for pharmaceutical drugs – in order to examine which things should and should not be patented. Speaking remotely in a fireside chat at the JP Morgan Healthcare Conference in January, he said the purpose would be to facilitate more generic drug launches, not just approvals. “One of my growing concerns, we’re approving a lot of drugs, but not seeing a commensurate number of drugs launched,” he said at the time.
Photo: Zach Gibson, Getty Images
This story has been updated from the original version to include statements from industry leaders.