FDA Commissioner Dr. Scott Gottlieb has handed in his resignation as head of the agency, according to a report in the Washington Post, which has been confirmed by HHS Secretary Alex Azar in a statement posted to his Twitter page as well as by Gottlieb himself later in the day. He will resign in one month.

"I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump - This has been a wonderful journey and parting is very hard," Gottlieb wrote.

The news is surprising, especially in light of a tweet Gottlieb fired off at the beginning of January.

"I’ve heard from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA," he wrote at the time. "I want to be very clear - I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon."

According to the Washington Post's reporting, Gottlieb, who has been making a long commute to work at the FDA, is resigning to spend more time with his family.

"Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month," President Trump tweeted today. "Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!"

What's the impact?

In just two years as commissioner, Gottlieb has accomplished a great deal, presiding over a number of digital health policy guidances. In fact, Gottlieb has been interested in the space since well before his appointment; he penned an editorial on health app deregulation for the Wall Street Journal in 2014.

His most ambitious — and controversial action has been the formation and launch of the FDA Pre-Cert Program, a new paradigm for clearing devices by evaluating companies more so than particular products. Pre-Cert is still a ways away from deployment — Gottlieb unveiled a Pre-Cert Test Plan for 2019 and a Working Model in January.

The program has been widely lauded by the industry, but has also been criticized for being narrow and for potentially lacking the necessary statutory authority.

What's the trend?

Gottlieb has served as commissioner since mid-2017, but prior to his appointment some fairly extreme choices were rumored to be on Trump's short list: Jim O’Neill, managing director at Peter Thiel’s Mithril Capital Management, and Balaji Srinivasan, founder of genomics company Counsyl. As we noted at the time, both are strongly anti-regulation. O’Neill has said that he would like to see the FDA shed its efficacy-evaluating functions and focus only on safety. Srinivasan, in a now-deleted tweet, argued that “a Yelp! for drugs” would be more helpful to consumers than the FDA.

It's hard to predict who Trump will tap to fill the vacancy left by Gottlieb, but whoever it is will have at least two years to shape policy at the agency, at a moment when many aspects of digital health regulations are in flux.

"I think this creates an opportunity for President Trump to find someone who is more likely to work with the new Congress," Bradley Merril Thompson, a partner at Epstein Becker Green who has been one of the program's critical voices, told MobiHealthNews in an email. "I think that much of what is on FDA's plate presently may well require the support of Congress, if not legislation. So having someone who has a good relationship with both sides of the aisle would be a positive."

On the record

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” Azar said in his statement. “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 of so many other members of the HHS family. 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. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

Read more at our sister publication Healthcare IT News.