Janet Woodcock, acting FDA commissioner (Greg Nash/Pool via AP Images)

Wood­cock de­fends FDA's re­sponse to Omi­cron be­fore Sen­ate health com­mit­tee

In what may be Janet Wood­cock’s fi­nal con­gres­sion­al hear­ing as the head of the FDA, she once again of­fered a can­did de­scrip­tion of the dif­fi­cul­ties of bat­tling the cur­rent Omi­cron out­break.

Speak­ing through two masks along­side oth­er CDC, NIH and HHS lead­ers, Wood­cock com­pared the cur­rent pan­dem­ic to a nat­ur­al dis­as­ter, adding, “I don’t think it will last a re­al­ly long time.”

“I think we need to fo­cus on con­ti­nu­ity of op­er­a­tions for hos­pi­tals,” she said in re­sponse to ques­tions from Sen. Mike Braun (R-IN) at the Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee meet­ing on Tues­day. “I think it’s hard to process what’s ac­tu­al­ly hap­pen­ing right now, which is that most peo­ple are go­ing to get Covid.”

She stressed the need to make sure the hos­pi­tals, trans­porta­tion and oth­er es­sen­tial ser­vices aren’t dis­rupt­ed and af­ter that, she said, it’ll be im­por­tant to re­assess what has been done and needs to be im­proved up­on.

“There’s an ex­treme un­met med­ical need for ther­a­peu­tics at most stages of the dis­ease, par­tic­u­lar­ly in the late stages, where we still don’t have in­ter­ven­tions and peo­ple are dy­ing, go­ing in­to the ICU and go­ing on the ven­ti­la­tor,” Wood­cock said, not­ing there are 670 INDs that are on­go­ing. “Ro­bust de­vel­op­ment is still on­go­ing in the ther­a­peu­tic area.”

In ques­tion­ing re­lat­ed to the FDA’s au­tho­riza­tion of rapid tests, which has come un­der fire — as many sen­a­tors lament­ed the woe­ful­ly in­ad­e­quate rapid test sup­plies — Wood­cock said it was more of an is­sue of man­u­fac­tur­ing ca­pac­i­ty ver­sus the au­tho­riza­tion process.

In her writ­ten tes­ti­mo­ny, Wood­cock not­ed that the FDA’s ac­tions have re­duced the re­view times for tests “from a peak av­er­age of 90 days for EUA re­quests re­ceived in Sep­tem­ber 2020 to ap­prox­i­mate­ly 35 days for those re­ceived since Feb­ru­ary 2021.”

“We could do more with more re­sources,” she said. “It’s an in­cred­i­ble in­crease in work­load,” she said of the tests, while prais­ing the NIH’s stan­dard­iza­tion work that ac­cel­er­ates the au­tho­riza­tion of some new tests, some­times to as quick­ly as two days, Wood­cock said.

Re­pub­li­cans like rank­ing mem­ber Richard Burr crit­i­cized Pres­i­dent Biden’s an­nounce­ment about boost­ers for all pri­or to FDA au­tho­riza­tion, and then the FDA’s ad­comm had to “bend to the whims of the po­lit­i­cal de­ci­sion al­ready made,” which he said cre­at­ed skep­ti­cism and con­fu­sion with the launch of boost­ers.

“Now we’re beg­ging peo­ple to get boost­ers, which is where we should’ve been on Day 1,” Burr said.

Wood­cock tes­ti­fied that the vac­cines au­tho­rized re­main high­ly ef­fec­tive against pre­vent­ing hos­pi­tal­iza­tion and death, and an ad­di­tion­al boost­er pro­vides fur­ther pro­tec­tion.

Sen. Mitt Rom­ney (R-UT) al­so crit­i­cized the Biden ad­min­is­tra­tion for not build­ing enough test­ing ca­pac­i­ty and ag­gres­sive­ly ramp­ing up pro­duc­tion, while Sen. Su­san Collins (R-ME) ques­tioned what AS­PR has done with more than $80 bil­lion ap­pro­pri­at­ed for tests, and test pro­duc­tion, when “no one can find a rapid test when they need them.”

“This cri­sis is en­tire­ly pre­ventable. The fact is that the ad­min­is­tra­tion failed to an­tic­i­pate our test­ing needs,” she added.

AS­PR head Dawn O’Con­nell ex­plained that the test­ing mon­ey has been used for test­ing, and she men­tioned that some funds were used to test chil­dren cross­ing the bor­der.

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.

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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.

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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.

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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.

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Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

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.

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.

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.

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.