Amy Abernethy (Andrew Harrer/Bloomberg via Getty Images)

FDA's No. 2 Amy Aber­nethy to leave the agency in April

The FDA’s prin­ci­pal deputy com­mis­sion­er of food and drugs and act­ing chief in­for­ma­tion of­fi­cer, Amy Aber­nethy, will leave the agency in mid-to-late April, ac­cord­ing to a sur­prise memo on Tues­day from Janet Wood­cock, the act­ing FDA com­mis­sion­er.

Aber­nethy’s sud­den de­par­ture comes a lit­tle more than two years since she joined the FDA, af­ter mak­ing the jump to pub­lic ser­vice from her post as chief med­ical of­fi­cer, chief sci­en­tif­ic of­fi­cer, and se­nior vice pres­i­dent for on­col­o­gy at Roche’s Flat­iron Health.

“I’m very sor­ry to see the FDA lose a tal­ent­ed and in­spir­ing se­nior leader like Amy, but I take heart in Amy’s en­dur­ing ac­com­plish­ments at the agency,” Wood­cock wrote in a memo to FDA staff.

Aber­nethy’s work at the agency in­volved a ma­jor re­struc­tur­ing of how in­for­ma­tion tech­nol­o­gy is used there, and she helped to es­tab­lish stan­dards for the use of re­al-world da­ta and ev­i­dence.

“When COVID-19 struck, Amy rapid­ly as­sem­bled flex­i­ble teams and projects to un­der­stand how nov­el da­ta and rig­or­ous analy­sis tech­niques could be de­ployed in sup­port of the FDA’s re­sponse to the pan­dem­ic. Amy’s in­sight that a di­verse group of pub­lic health and da­ta ex­perts from mul­ti­ple sec­tors could come to­geth­er to work on pan­dem­ic-re­lat­ed analy­sis projects in a trans­par­ent, col­lab­o­ra­tive set­ting led to the cre­ation of the COVID-19 Ev­i­dence Ac­cel­er­a­tor, which has emerged as a unique and promis­ing mod­el for ad­vanc­ing the sci­ence of pub­lic health,” Wood­cock wrote.

Aber­nethy’s de­par­ture comes at a crit­i­cal time for the agency as Pres­i­dent Biden has yet to nom­i­nate a per­ma­nent FDA com­mis­sion­er, and the agency is grap­pling with an in­creased work­load from the pan­dem­ic, as well as the re-ne­go­ti­a­tion of user fee deals ahead of next year and an ex­pand­ing back­log of in­spec­tion work.

A for­mer se­nior FDA of­fi­cial told End­points News she thinks Aber­nethy was promised a lot when she came on board, and af­ter two years of not re­ceiv­ing con­sid­er­a­tion as the next FDA com­mis­sion­er, she de­cid­ed to leave.

You can read Wood­cock’s full memo here.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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