Top FDA of­fi­cial ac­cused CDER chief Wood­cock of ap­pear­ing bi­ased, brow­beat­ing re­view­ers in de­mand­ing eteplirsen OK

While FDA com­mis­sion­er Rob Califf was try­ing to nav­i­gate an in­ter­nal civ­il war at the agency over its con­tro­ver­sial de­ci­sion to pro­vide an ac­cel­er­at­ed ap­proval for Sarep­ta’s eteplirsen, John Jenk­ins, then head of the Of­fice of New Drugs, sent him a memo which de­tailed a blis­ter­ing at­tack on CDER chief Janet Wood­cock.

Janet Wood­cock

It was Wood­cock who de­mand­ed, and won, the ar­gu­ment in fa­vor of an ac­cel­er­at­ed OK of the Duchenne mus­cu­lar dy­s­tro­phy drug.

But Jenk­ins, who sided with oth­er top of­fi­cials at the FDA in op­pos­ing the ap­proval, says that Wood­cock cre­at­ed an “ap­pear­ance of bias” in push­ing for the ap­proval from an ear­ly point. Wood­cock, he wrote Califf in a memo dat­ed Sep­tem­ber 14, 2016, left the FDA re­view team feel­ing pres­sured to come over to her side. And she by­passed the usu­al chain of com­mand to get what she want­ed, in­sist­ing on an ap­proval even be­fore the re­view team had com­plet­ed its task and leav­ing them dis­trust­ful of her role and man­ner.

Not on­ly did Jenk­ins ob­ject to Wood­cock’s han­dling of eteplirsen, a drug which had the vo­cal sup­port of the Duchenne com­mu­ni­ty, he al­so told Califf that he had de­layed his re­tire­ment specif­i­cal­ly be­cause Wood­cock in­tend­ed to take his place af­ter he left. And that is ex­act­ly what she did.

The memo was high­light­ed in a re­port by Charles Seife on Un­dark, an on­line site that al­so in­clud­ed a copy of the full let­ter. You can read the whole doc­u­ment here.

While Califf pub­lished much of the doc­u­men­ta­tion around the dis­pute, this par­tic­u­lar memo did not sur­face un­til Seife’s FOIA law­suit forced it out. And it in­cludes the re­mark­able sug­ges­tion that Califf should coun­sel the pow­er­ful CDER chief on her man­ner and her meth­ods.

Jenk­ins has since re­tired from the FDA, but he de­clined to talk to Seife, as did Wood­cock. But his memo de­serves care­ful at­ten­tion. One ex­cerpt:

John Jenk­ins

On page 4, you state “there is al­so abun­dant ev­i­dence that Dr. Wood­cock heard and read FDACDER0001 all the sci­en­tif­ic ev­i­dence…” This im­plies she took these ac­tions BE­FORE reach­ing a de­ci­sion on the ap­pli­ca­tion, which is clear­ly not cor­rect giv­en her state­ment to the re­view team of her in­ten­tion to over­rule them and ap­prove the drug BE­FORE they had com­plet­ed their re­views. Keep in mind this oc­curred af­ter an AC (ad­vi­so­ry com­mit­tee) meet­ing at which the ma­jor­i­ty of the pan­el vot­ed against both AA and full ap­proval. It is al­so clear that she was pre­pared to ap­prove the drug over the team’s ob­jec­tions by the orig­i­nal PDU­FA goal date and on­ly re­luc­tant­ly agreed to press the spon­sor for ad­di­tion­al da­ta on dy­s­trophin pro­duc­tion from the on­go­ing open-la­bel tri­al. While I am glad she agreed to go along with that re­quest, con­vinc­ing her to take what seemed like a very log­i­cal ac­tion was not easy. So, I find it hard to rec­on­cile your state­ments about the process with the ac­tions tak­en. Keep in mind that the usu­al course of ac­tion would be for the Of­fice to is­sue a CR let­ter and then the spon­sor could sub­mit a FDRR that would first come to me and on­ly if I sup­port­ed the Of­fice would an FDRR go to the Cen­ter Di­rec­tor. In this case that process was by­passed.

His memo goes on to out­line his con­cerns about the com­plete lack of da­ta on ef­fi­ca­cy as well as con­cerns that ac­cel­er­at­ed ap­proval would clear­ly low­er the bar at the agency on a new drug OK.

Al­so on page 9 it is iron­ic that you at­tribute to Janet the idea of ran­dom­iz­ing ear­ly in or­der to gen­er­ate good ev­i­dence. That is ex­act­ly what the re­view team planned to re­quire of Sarep­ta af­ter the re­sults of the 12-pa­tient study be­came avail­able, but it was Janet that pressed that a new ran­dom­ized tri­al not be re­quired. So, if Janet had fol­lowed the nor­mal CDER process in this case the re­view team would have re­quired place­bo-con­trolled tri­als, as they did for dris­apersen and we would have bet­ter da­ta on which to make a de­ci­sion.

Jenk­ins stops one step short of ac­cus­ing Wood­cock of bul­ly­ing the staff.

While I un­der­stand your de­sire not to un­der­cut her role as Cen­ter Di­rec­tor, her ac­tions have at best cre­at­ed a serous …ap­pear­ance of bias among the re­view team mem­bers and that has cre­at­ed dis­trust and a sense of un­due pres­sure to “come around” to her way of think­ing. Even if you up­hold her de­ci­sion I would think you should coun­sel her about how her be­hav­ior and ac­tions have un­der­mined her cred­i­bil­i­ty among the re­view staff and should be avoid­ed in fu­ture sim­i­lar cas­es. Ef­fec­tive lead­ers must have the trust and re­spect of their staff.

Lat­er, just be­fore he re­tired, Jenk­ins gave a speech in which he tried to warn oth­er drug de­vel­op­ers to avoid try­ing to fol­low the same path that Sarep­ta took. But he was clear­ly con­cerned about the fu­ture:

As you know, I had planned to re­tire from FDA last spring. I have de­layed my de­par­ture for a va­ri­ety of rea­sons, but one of the most im­por­tant rea­sons is that Janet has told me she plans to serve as act­ing in my place as head of OND once I leave. I am very con­cerned about the im­pact of that de­ci­sion on the fu­ture of the new drugs re­view pro­gram and would be hap­py to dis­cuss those con­cerns fur­ther.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

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Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

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The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

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The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

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The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs from 2020.

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