Ned Sharp­less is not play­ing with the FDA’s gold stan­dard — any more than Scott Got­tlieb did

Ned Sharp­less got a chance to out­line just what kind of act­ing FDA chief he’ll be in the wake of Scott Got­tlieb’s de­par­ture from the agency. And aside from a more con­ser­v­a­tive se­lec­tion of socks, he’s clear­ly plan­ning to adopt the ex­act same fash­ions laid down by his pre­de­ces­sor.

Ned Sharp­less. (DARR BEIS­ER/NA­TION­AL CAN­CER IN­STI­TUTE)

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In an all-hands-on-deck ad­dress to staffers, Sharp­less promised to fit the Got­tlieb mold per­fect­ly, vow­ing to main­tain the agency’s gold stan­dard on drug ap­provals while do­ing what he can to keep the copy­cats com­ing to help tamp down on drug costs.

So let me re­as­sure you, I am not plan­ning any rad­i­cal changes from what the FDA has been try­ing to ac­com­plish.

Bioreg­num Opin­ion Col­umn by John Car­roll

That’s a theme that will be mu­sic to the ears of the bio­phar­ma in­dus­try, which quick­ly swooned to Got­tlieb’s en­er­getic mes­sages on speed­ing ap­provals when­ev­er ap­pro­pri­ate while hold­ing the line on safe­ty and ef­fi­ca­cy stan­dards. The fu­ture of the FDA proved to be a huge is­sue at the start of Pres­i­dent Don­ald Trump’s term in of­fice, as Trump en­ter­tained some lib­er­tar­i­an no­tions that fright­ened the be­je­sus out of com­pa­nies that clear­ly want­ed a more re­cep­tive reg­u­la­to­ry ap­proach — with­out any reg­u­la­to­ry an­ar­chy that would de­stroy the val­ue of an FDA OK.

Sharp­less got right to it. His bot­tom line:

Nec­es­sar­i­ly, there will be course ad­just­ments as new facts emerge, but es­sen­tial­ly, I feel I am walk­ing in­to an or­ga­ni­za­tion on a good tra­jec­to­ry, and my main job is to fig­ure out how keep that go­ing.

Now how to do that:  let me sug­gest two guid­ing prin­ci­ples.

First, I be­lieve our ef­forts should re­ly on and be guid­ed by the sci­ence. As a re­searcher, I am used to let­ting da­ta dri­ve my de­ci­sion-mak­ing, and I know this has al­ways been the ap­proach at FDA.

Sec­ond, when wran­gling with the com­plex is­sues that face the agency, we will keep top of mind our mis­sion of pro­tect­ing and pro­mot­ing pub­lic health, and what that means to the Amer­i­can pub­lic.

So that’s what will steer my pri­or­i­ties as act­ing com­mis­sion­er: a com­mit­ment to sci­ence-based de­ci­sion-mak­ing and pri­or­i­tiz­ing our ef­forts for the ben­e­fit of the pub­lic health.

That mes­sage on con­ti­nu­ity ex­tends to the agency’s work hus­tling up less ex­pen­sive knock­offs.

I promise you, for ex­am­ple, that we’ll con­tin­ue our im­por­tant and suc­cess­ful work to in­crease com­pe­ti­tion and reign in pre­scrip­tion drug costs through ad­vances in our gener­ic drug and biosim­i­lars pro­grams

And we’ll con­tin­ue to do every­thing we can to make the de­vel­op­ment of new treat­ments and cures more ef­fi­cient across our med­ical prod­uct cen­ters, while en­sur­ing that we main­tain FDA’s gold stan­dard of safe­ty and ef­fi­ca­cy.

What could be more re­as­sur­ing to the in­dus­try, law­mak­ers and the pub­lic?

In­ter­est­ing­ly, Got­tlieb’s de­par­ture from the FDA was al­so marked by his in­sis­tence that the rank-and-file drug de­vel­op­ers of the world need­ed to do more to adopt the re­forms he had pushed, look­ing for faster, more ef­fi­cient ways to de­vel­op drugs. The chal­lenge for Sharp­less will be to see if he con­tin­ues that push as an in­dus­try train­er look­ing to get some out-of-shape de­vel­op­ers up to speed with the new or­der. And that means urg­ing reg­u­la­tors as well to get the lead out.

Scott Got­tlieb

Con­ti­nu­ity may sound like the ex­act right mes­sage here and now. But if that be­comes a con­ser­v­a­tive ap­proach to main­tain­ing stan­dards and tra­di­tions, plea­sure may soon be re­placed by an un­easy feel­ing that the FDA may once again be­come more of an ob­sta­cle and less of a part­ner. And that won’t be wel­come.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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