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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

CMS spent more than $18B in four years on ac­cel­er­at­ed ap­provals with in­com­plete con­fir­ma­to­ry tri­als, in­spec­tor gen­er­al finds

The battle over whether and how to reform the FDA’s accelerated approval pathway is heating up again, just as the Senate punted any talks until the lame duck session just before the end of the year.

On Thursday, HHS’ inspector general released a new report reiterating concerns, also noted recently by the FDA’s Oncology Center of Excellence, about delayed or slowed confirmatory trials that are necessary to prove that the accelerated approvals were worth their salt in the first place.

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Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images)

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would alter a federal mandate for animal testing on new drugs, but stops short of removing animal testing entirely.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.