FDA paus­es do­mes­tic drug in­spec­tions again, this time to pro­tect against Omi­cron

The FDA qui­et­ly an­nounced on Tues­day that just be­fore New Year’s eve, the agency again paused all of its non-mis­sion-crit­i­cal in­spec­tions in the US, like­ly lead­ing to an even larg­er back­log of in­spec­tions world­wide.

The pause, which will last at least two weeks, is meant to en­sure the safe­ty of FDA em­ploy­ees and the com­pa­nies it reg­u­lates as the agency fur­ther adapts to the spread of Omi­cron.

“Through Jan.19, the agency in­tends to con­tin­ue mis­sion-crit­i­cal work but has tem­porar­i­ly post­poned cer­tain in­spec­tion­al ac­tiv­i­ties with the hopes of restart­ing these ac­tiv­i­ties as soon as pos­si­ble,” the FDA said in a state­ment.

The agency had on­ly just re­turned to rel­a­tive­ly nor­mal do­mes­tic in­spec­tions last Ju­ly, af­ter a long pre­vi­ous pause that be­gan as the pan­dem­ic hit in ear­ly 2020. In a re­port from last No­vem­ber, the agency not­ed that 52 new drug ap­pli­ca­tions were de­layed as a re­sult of the in­spec­tion back­log cre­at­ed by that long pause.

On the for­eign in­spec­tion side, where ac­tiv­i­ties have still been most­ly on pause since ear­ly 2020, FDA said it’s post­pon­ing the plan­ning of pri­or­i­tized sur­veil­lance for­eign in­spec­tion as­sign­ments that were sched­uled to be­gin in Feb­ru­ary 2022.

But the FDA said it will con­tin­ue con­duct­ing mis­sion-crit­i­cal for­eign and do­mes­tic in­spec­tions.

Be­tween April and Sep­tem­ber 2021, the FDA said it com­plet­ed just 37 for­eign drug in­spec­tions, which com­pares with more than 1,200 in 2019.

And the FDA’s to­tal tal­ly for drug and bi­o­log­ic in­spec­tions in 2020 shows how the agency con­duct­ed 1,500 few­er in­spec­tions in 2020, when com­pared to 2019 (and over 2,600 few­er when com­pared to 2011). On­ly 74 in­spec­tions end­ed with an Of­fi­cial Ac­tion In­di­cat­ed in 2020, which com­pared with 202 OAIs in 2019.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but that hasn’t proven to be a ma­jor help as the back­log is filled most­ly with sur­veil­lance in­spec­tions, and the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

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

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.