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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Herriot Tabuteau, Axsome CEO (Owen Hoffmann/Patrick McMullan via Getty Images)

Ax­some's long de­layed de­pres­sion drug is back up for la­bel dis­cus­sions at the FDA, trig­ger­ing a big spike in the share price

Axsome’s on-and-off quest to obtain an FDA approval for their depression drug AXS-05 is back on again.

After the markets closed on Monday, the biotech issued a short, simple alert in an SEC filing saying the team had “received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.”

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.