Joe Biden (AP Photo/Susan Walsh)

Opin­ion: Plen­ty of qual­i­fied peo­ple are ready to run the FDA. Time for Biden to choose one

As the Delta vari­ant ramps up and the FDA pre­pares to ful­ly ap­prove Covid-19 vac­cines and quick­ly re­view boost­er shots this fall, the agency des­per­ate­ly needs a per­ma­nent com­mis­sion­er.

Al­though FDA of­fi­cials have re­as­sured the pub­lic that their jobs con­tin­ue as ex­pect­ed, even with­out a per­ma­nent leader for more than 200 days now, there’s no ques­tion that hav­ing a Sen­ate-con­firmed head for FDA is ex­treme­ly im­por­tant dur­ing a once-in-a-cen­tu­ry pan­dem­ic, and even more so to de­vel­op longer-term, agency-wide strate­gies to help pre­pare for the next pan­dem­ic.

The White House doesn’t seem to have the votes (or doesn’t want a Re­pub­li­can-led con­fir­ma­tion) to tran­si­tion Janet Wood­cock and her four decades of FDA ex­pe­ri­ence from act­ing to per­ma­nent sta­tus. The opi­oid cri­sis and oth­er de­ci­sions she made while lead­ing CDER (e.g., Sarep­ta’s eteplirsen and Bio­gen’s ad­u­canum­ab ap­provals) weigh on her nom­i­na­tion, with at least one De­mo­c­ra­t­ic sen­a­tor, Joe Manchin of West Vir­ginia, pub­licly call­ing on Biden not to nom­i­nate Wood­cock.

But Wood­cock can re­main in her cur­rent, act­ing role un­til about mid-No­vem­ber, and it seems like the Biden ad­min­is­tra­tion has every in­ten­tion to run out the clock on her tenure, even if she isn’t nom­i­nat­ed for the per­ma­nent spot in the end.

Strange­ly, the ad­min­is­tra­tion has con­sis­tent­ly be­moaned the lack of promis­ing FDA com­mis­sion­er can­di­dates, even as the White House has had plen­ty of time to se­lect and vet qual­i­fied can­di­dates.

With this dif­fi­cul­ty in iden­ti­fy­ing FDA com­mis­sion­er can­di­dates in mind, here are 10 qual­i­fied peo­ple who could serve the agency well in the top slot, and ad­vance FDA’s role in cre­at­ing the gold stan­dard in med­ical prod­uct ap­provals (pre­sent­ed in no par­tic­u­lar or­der):

The aca­d­e­mics

  • Er­ic Topol — He’s a well-re­spect­ed car­di­ol­o­gist who un­der­stands the way FDA works, isn’t afraid to stand up to po­lit­i­cal med­dling in sci­en­tif­ic de­ci­sions, es­pe­cial­ly with re­gard to the pan­dem­ic, and is a well-round­ed pub­lic health com­mu­ni­ca­tor.
  • Joshua Sharf­stein — His name was float­ed as an ear­ly con­tender for the FDA’s top job, but then Biden seemed to think he might not be a good se­lec­tion. Per­haps his name resur­faces again? His aca­d­e­m­ic col­leagues all think high­ly of him, and he knows the agency well giv­en his pri­or ex­pe­ri­ence.
  • Aaron Kessel­heim — Al­though Kessel­heim, a Har­vard pro­fes­sor of med­i­cine, re­cent­ly re­signed from the FDA ad­comm that vot­ed unan­i­mous­ly to re­ject Bio­gen’s new Alzheimer’s drug when it was ap­proved, per­haps the Biden ad­min­is­tra­tion can bring him back in­to the fold at FDA. Again, he’s a well-re­spect­ed physi­cian, pro­fes­sor and fre­quent au­thor of pa­pers on var­i­ous FDA poli­cies. Cer­tain­ly, the learn­ing curve would be sig­nif­i­cant­ly less steep for some­one like Dr. Kessel­heim when com­pared with oth­ers.
  • Caleb Alexan­der — An­oth­er aca­d­e­m­ic leader with a strong un­der­stand­ing of the FDA, and who has served on mul­ti­ple FDA ad­comms, in­clud­ing the re­cent Bio­gen one. Alexan­der, a pro­fes­sor at Johns Hop­kins, might pro­vide a unique per­spec­tive to an agency that hasn’t seen an aca­d­e­m­ic leader in the top spot since Duke’s Rob Califf led it.
  • Car­los Del Rio — The Emory pro­fes­sor has been track­ing and ad­vis­ing state and lo­cal gov­ern­ments on the ins and outs of the pan­dem­ic since it be­gan. His clear com­mu­ni­ca­tions have made him a well-re­spect­ed source of in­for­ma­tion.

For­mer FDAers and in­dus­try lead­ers

  • Ken Fra­zier — The for­mer Mer­ck CEO, who stepped down at the be­gin­ning of Ju­ly, is a high-pro­file trail­blaz­er who could of­fer a fa­mil­iar face to the FDA, es­pe­cial­ly with his knowl­edge of the bio­phar­ma in­dus­try, its in­ner work­ings and his ex­cep­tion­al lead­er­ship skills.
  • Michelle Mc­Mur­ry-Heath — As the head of in­dus­try group BIO, Mc­Mur­ry-Heath’s name has sur­faced and re-sur­faced again as a pos­si­ble top con­tender for the FDA com­mis­sion­er job. While she hasn’t com­ment­ed on the prospect, her pub­lic op­po­si­tion to cer­tain Biden-backed ini­tia­tives, like the TRIPS waiv­er be­fore the WTO and Medicare ne­go­ti­a­tions on drug prices, may not win over too many more De­moc­rats than Wood­cock.
  • John Jenk­ins — A long-time FDA di­rec­tor in the Of­fice of New Drugs, Jenk­ins knows the agency (more than 2 decades of ex­pe­ri­ence) and un­der­stands how it works. He al­so served in a high-pro­file po­si­tion for more than a decade, as well as on the oth­er side, with his re­cent in­dus­try con­sult­ing work at Green­leaf Health.
  • Scott Got­tlieb — Clear­ly a fa­vorite among FDA staff from his pre­vi­ous run as com­mis­sion­er dur­ing the Trump ad­min­is­tra­tion. Got­tlieb’s name comes up again, de­spite his role on Pfiz­er’s board and oth­er lu­cra­tive po­si­tions, per­haps be­cause of how con­sis­tent­ly ac­cu­rate he’s been in dis­cussing the pan­dem­ic week in and week out on tele­vi­sion and Twit­ter.
  • Lu­ciana Bo­rio — A for­mer act­ing chief sci­en­tist at FDA, she was vet­ted by Biden’s team for the top job ear­ly on, but has since tak­en on new roles at ARCH Ven­ture Part­ners, so she may be out of the run­ning.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

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