Nei­ther Janet Wood­cock nor Joshua Sharf­stein is like­ly to be nom­i­nat­ed as the per­ma­nent FDA com­mis­sion­er, Steve Us­din at Bio­Cen­tu­ry re­ports.

Janet Wood­cock

The White House is look­ing for al­ter­na­tives to Wood­cock, the act­ing chief and long­time CDER di­rec­tor, af­ter op­po­si­tion from sev­er­al De­mo­c­ra­t­ic sen­a­tors who are call­ing on oth­ers to block her nom­i­na­tion if her name is put forth, ac­cord­ing to Us­din. Sharf­stein, the for­mer prin­ci­pal deputy FDA com­mis­sion­er and cur­rent Johns Hop­kins pro­fes­sor, is out of the run­ning al­to­geth­er.

As the va­can­cy at the helm of an agency tasked with over­see­ing the de­vel­op­ment and re­view of Covid-19 vac­cines be­came more con­spic­u­ous by the day — prompt­ing the New York Times to ask, “Who will be the next FDA chief?” — dis­tinct camps had formed around the two lead­ing can­di­dates.

Wood­cock earned plau­dits ear­ly from pa­tient ad­vo­ca­cy or­ga­ni­za­tions and bio­phar­ma­ceu­ti­cal com­pa­nies, the same groups that have spo­ken out against Sharf­stein for lack of ex­pe­ri­ence.

Joshua Sharf­stein

But there was a par­tic­u­lar group of ac­tivists who made their dis­dain for Wood­cock clear: those fight­ing the opi­oid abuse epi­dem­ic. And they be­lieve Wood­cock should be held re­spon­si­ble for “one of the worst reg­u­la­to­ry agency fail­ures in U.S. his­to­ry,” not on­ly over­see­ing but de­fend­ing “harm­ful opi­oid de­ci­sions.”

Sen­a­tors from some of states worst hit by the opi­oid cri­sis were re­port­ed to be her fiercest op­po­nents, in­clud­ing Sen­a­tors Mag­gie Has­san from New Hamp­shire, Ed Markey from Mass­a­chu­setts and Joe Manchin from West Vir­ginia.

Less pub­li­cized, per­haps, was the harsh cri­tique that some in­dus­try in­sid­ers re­served for Wood­cock over what they per­ceived as the loos­en­ing of the FDA’s reg­u­la­to­ry stan­dards, man­i­fest­ed in her de­ci­sion to over­rule FDA staffers and ap­prove Sarep­ta’s eteplirsen with­out clin­i­cal proof that their Duchenne mus­cu­lar dy­s­tro­phy drug works.

In a re­cent let­ter to Pub­lic Cit­i­zen, Wood­cock shut down the watch­dog’s pro­pos­al of a fire­wall be­tween reg­u­la­tors and drug com­pa­nies, ar­gu­ing it would un­nec­es­sar­i­ly “re­duce the ef­fi­cien­cy of FDA’s re­view process and cause de­lays in drug de­vel­op­ment.”

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.