In two years, Gottlieb tried to foster digital health approvals and medical device cybersecurity.
Update: Gottlieb and President Donald Trump have confirmed that Gottlieb is leaving the FDA. In a tweet, he said he is “immensely grateful for the opportunity to help lead this wonderful agency” and for support from his colleagues and the president. “This has been a wonderful journey and parting is very hard.”
Scott Gottlieb, M.D., plans to resign his post as commissioner of the U.S. Food and Drug Administration (FDA), according to a report in the Washington Post.
Gottlieb reportedly resigned today, March 5, but he will continue to head the agency for another month. The 46-year-old, who was appointed FDA commissioner in May 2017, told a White House official that he was leaving to spend more time with his family in Connecticut, according to the Post.
“He has been an exemplary public health leader, aggressive advocate for American patients and passionate promoter of innovation,” U.S. Department of Health and Human Services Secretary Alex Azar said in a statement to the newspaper.
In Gottlieb’s two years overseeing the FDA, he prioritized modernizing the regulator to better accommodate digital health innovation and improve medical device cybersecurity.
During his tenure, the FDA embarked on a much-discussed pilot program exploring digital health precertification. The Precert program brought together giants like Apple and Johnson & Johnson and startups such as Pear Therapeutics in an attempt to develop standards to support safe but less time-consuming software approvals.
He notably drove the FDA through the aftershock of the WannaCry and NotPetya cyberattacks, which disrupted healthcare and cemented the industry’s vulnerability to hackers.
Gottlieb also unveiled an app for collecting real-world data and stumped for artificial intelligence, next-generation genome sequencing and modernized clinical trials.
In recent months, he made a visible effort to bring health-tech experts into the FDA’s senior leadership. For example, Gottlieb hired Amy Abernethy, M.D., Ph.D., a former executive of Flatiron Health, to serve as deputy commissioner.
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