Popular FDA commish Scott Gottlieb has handed in his resignation

In a stunning turn of events, FDA commissioner Scott Gottlieb is resigning from his post and leaving office in a matter of weeks.

The Washington Post reported that Gottlieb, who’s been commuting from Connecticut, told administration officials that he wants to spend more time with his family.

Gottlieb arrived at the FDA shortly after the Trump administration took office, vowing to uphold the gold standard in drug development while doing everything possible to facilitate drug makers’ work — at least for the legitimate players.

He has been enormously popular in his short stint, with the vast majority of biopharma execs acclaiming his work at the agency. He’s also been popular with President Donald Trump, finding a secure spot for himself in an administration noted for rapid turnover.

So what happened here?

Just weeks ago Gottlieb insisted on Twitter that rumors of his pending departure from the agency were flat wrong. He tweeted:

We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon.

The big question now is who will replace him. Trump freaked out many execs by entertaining Peter Thiel’s push for a libertarian approach, which would have erased many of the barriers to introducing new drugs — along with the credibility that goes with an FDA sanction. Trump, though, has many open positions in his administration, including Cabinet-level posts. Stephen Ostroff has taken the helm on a strictly interim basis before, but he retired last fall, replaced by Walmart executive Frank Yiannas.

Gottlieb’s letter of resignation includes his list of accomplishments for the past 23 months, from a record number of new drug approvals to their continued work on mastering new technologies and taking on e-cigarette use by minors.

I’m confident that the FDA will continue to advance all these efforts, and many other goals.

Industry leaders quickly noted the significance of the move today.

“We’re going to miss him. He was a terrific leader of the FDA,” Alnylam CEO and BIO chairman John Maraganore told me.

“It’s a damn shame,” Tweeted longtime serial entrepreneur Mike Gilman, echoing the sharp level of disappointment about the news.

There are plenty of qualified people that this doesn't need to be a negative. But the thing I do worry about with the environment in Washington these days is that it will take forever for the next person to get approved.

— Brad Loncar (@bradloncar) March 5, 2019

….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!

— Donald J. Trump (@realDonaldTrump) March 5, 2019

Image: Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), poses for portrait photographs in front of the old FDA sign at the FDA in White Oak, MD on November 5, 2018 The Washington Post