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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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John Roberts, exiting Vyant Bio CEO

Neu­rode­gen­er­a­tive biotech Vyant warns of po­ten­tial wind-down

The CEO and chief scientific officer of Vyant Bio are out the door as the little-known but publicly-listed neurodegenerative biotech searches for an exit or, if all else fails, a wind-down.

The soul-searching bookends a winding journey for the biotech, which rebranded and transitioned from diagnostics company Cancer Genetics in 2021 after a merger with StemoniX. That came after a failed merger attempt with NovellusDx (now Fore Biotherapeutics) in 2018. In the last few years, units have been sold off and the stock price $VYNT has plummeted from the $30 range to penny stock territory.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Medicago's vaccine greenhouse (Medicago via YouTube)

Cana­di­an plant-based vac­cine de­vel­op­er Med­ica­go shut­ters months af­ter lay­offs

Plant-based Covid-19 vaccine developer Medicago shut down this week with little fanfare. And its two subsidiaries, Medicago R&D and Medicago USA, are also closing their doors, according to a company news release.

The lone shareholder left standing, Japan-based Mitsubishi Chemical Group, “has determined not to make further investments in Medicago and to proceed with an orderly wind-up of its business and operations in Canada and in the United States.”

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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