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

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

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