Opin­ion: Biden needs to step up and nom­i­nate an FDA com­mis­sion­er

Enough with the wait­ing. Pres­i­dent Joe Biden needs to em­brace the FDA dur­ing this pan­dem­ic and kick­start the Sen­ate con­fir­ma­tion process for the next per­ma­nent com­mis­sion­er.

And this needs to hap­pen quick­ly. There are plen­ty of qual­i­fied can­di­dates for the role out­side of act­ing com­mis­sion­er Janet Wood­cock and Josh Sharf­stein. Biden needs to move fast not be­cause the bio­phar­ma world strug­gles with even the per­cep­tion of FDA un­cer­tain­ty (it does), but be­cause thou­sands of FDA em­ploy­ees have been deal­ing with four years of po­lit­i­cal smears while putting in over­time to re­view thou­sands of Covid-19 drug and vac­cine tri­als, and to au­tho­rize three safe vac­cines in record time.

Their hard work should be re­paid with some good news and longer-term di­rec­tion, and it’s time the pub­lic saw state­ments and com­ments from the FDA com­mis­sion­er, not the act­ing com­mis­sion­er.

The po­lit­i­cal pres­sure and name call­ing (Trump once re­ferred to the FDA as a “big, old, slow tur­tle,”) have come and gone. Now, the FDA must wait (com­ing up on three months, plus at least an­oth­er cou­ple for the con­fir­ma­tion process) be­fore they get an of­fi­cial leader and po­lit­i­cal staff they can look to for en­cour­age­ment rather than em­bar­rass­ment from for­mer FDA com­mis­sion­er Stephen Hahn’s ex­ag­ger­a­tion of the ben­e­fits of con­va­les­cent plas­ma and sub­se­quent apol­o­gy tour, and the fir­ing of a for­mer Wash­ing­ton Times ed­i­tor turned com­mu­ni­ca­tions leader just 11 days in­to the job.

As many at the agency have ex­plained in pub­lic and pri­vate, it doesn’t re­al­ly mat­ter who’s at the very top (un­less it’s Scott Got­tlieb, every­one at FDA adores Dr. Got­tlieb) be­cause the com­mis­sion­er’s job is most­ly about serv­ing as the pub­lic face of the agency, and less about dri­ving the dai­ly agen­da, most of which is set months and years in ad­vance.

But it does mat­ter that there’s some­one in that top slot who’s a cham­pi­on for pub­lic safe­ty, com­pe­tent and who un­der­stands how the agency works, and what that role can and can­not do. No one wants an FDA com­mis­sion­er who needs to learn the ropes over the first 3-6 months, on­ly to leave af­ter a year.

So what’s the hold up for Biden?

For a pres­i­dent who has made clear his in­ten­tion to re­move his pre­de­ces­sor’s po­lit­i­cal traps around pub­lic health, and to res­ur­rect the bat­tered CDC, Biden re­mained mum on FDA and his fail­ure to name FDA’s per­ma­nent com­mis­sion­er seems to be very much about pol­i­tics.

At least four Sen­ate De­moc­rats – Mag­gie Has­san of New Hamp­shire, Ed Markey of Mass­a­chu­setts, Joe Manchin of West Vir­ginia and Cather­ine Cortez Mas­to of Neva­da – have pre-empt­ed Biden’s nom­i­na­tion and voiced their op­po­si­tion to the lead­ing con­tender for the job, Wood­cock.

The opi­oid epi­dem­ic re­mains at the fore­front of some of the sen­a­tors’ minds, and right­ly so, con­sid­er­ing the dev­as­ta­tion across the coun­try. Oth­ers have raised con­cerns on in­dus­try in­flu­ence, but Got­tlieb did a sol­id job of show­ing how pri­or in­dus­try ex­pe­ri­ence does not nec­es­sar­i­ly re­flect on life as a com­mis­sion­er.

What those sen­a­tors fail to ac­count for in their op­po­si­tion to Wood­cock is that the FDA is well past the days when a com­mis­sion­er is mak­ing uni­lat­er­al de­ci­sions for the en­tire agency, or when in­dus­try in­flu­ence might tip the scale. The bio­phar­ma in­dus­try owns the scale. Al­most 70% of the FDA’s bud­get for drugs is from in­dus­try user fees. Work­ing with in­dus­try isn’t just in the job de­scrip­tion, it’s a large part of the rea­son FDA ex­ists now. But it’s the oth­er, much more im­por­tant part of FDA’s role, the part where the FDA pro­tects the Amer­i­can pub­lic and Amer­i­cans can trust the voice of the com­mis­sion­er. That should push Biden to move for­ward with a per­ma­nent com­mis­sion­er.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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