Janet Woodcock, acting FDA commissioner (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Over­sight Com­mit­tee digs in on McK­in­sey's con­flict­ing ties with FDA, opi­oids, and block­ing Hu­mi­ra com­peti­tors

McK­in­sey is un­der fire again, this time from the House Over­sight Com­mit­tee, which is dig­ging in­to the con­sult­ing firm’s close ties to the FDA while work­ing si­mul­ta­ne­ous­ly to pro­mote opi­oids and find ways to stall com­pe­ti­tion for Ab­b­Vie’s block­buster rheuma­toid arthri­tis drug Hu­mi­ra.

Since 2008, FDA has paid McK­in­sey over $140 mil­lion for var­i­ous tasks re­lat­ing to opi­oids, drug safe­ty, and drug ap­provals, as well as a “track and trace” sys­tem for drugs, mon­i­tor­ing pro­grams to as­sess drug safe­ty, and ways to stream­line the drug ap­proval process.

But Pur­due Phar­ma’s records show, ac­cord­ing to the com­mit­tee, that at the same time McK­in­sey was ad­vis­ing FDA, in­clud­ing of­fices re­spon­si­ble for opi­oid pro­grams, the com­pa­ny was al­so ad­vis­ing Pur­due on how to lob­by the FDA.

“For in­stance, in 2008, FDA pro­posed new safe­ty rules for Oxy­Con­tin un­der the agency’s Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies (REMS) pro­gram—in­clud­ing a re­quire­ment that the painkiller could be pre­scribed on­ly by spe­cial­ly trained phar­ma­cies or health­care prac­ti­tion­ers,” the com­mit­tee says. Pur­due hired McK­in­sey, which suc­cess­ful­ly re­buffed stronger REMS safe­ty mea­sures un­til 2012, de­spite the ob­jec­tions of an in­de­pen­dent pan­el of ex­perts who rec­om­mend­ed more rig­or­ous train­ing for pre­scribers and the re­duc­tion of in­dus­try in­flu­ence in the safe­ty mea­sures.

“It is not known to what ex­tent McK­in­sey con­sult­ed for the opi­oid in­dus­try dur­ing this same pe­ri­od, how much McK­in­sey re­ceived in com­pen­sa­tion from opi­oid-re­lat­ed en­ti­ties, or whether FDA con­sult­ed with McK­in­sey on the de­ci­sion to re­ject stronger safe­ty rules,” the com­mit­tee’s let­ter to McK­in­sey on Fri­day said.

Sen. Mag­gie Has­san (D-NH), whose state has been hit hard by the opi­oid cri­sis, di­rect­ly ques­tioned FDA act­ing com­mis­sion­er Janet Wood­cock on Thurs­day about how the FDA didn’t know un­til re­cent­ly about its con­flict­ing work with McK­in­sey, which was al­so con­sult­ing for opi­oids man­u­fac­tur­ers while work­ing on the FDA’s track-and-trace sys­tem. But Wood­cock said that she did know, and she said she didn’t think there was any­thing im­prop­er go­ing on.

“Well, speak­ing for my­self, I was aware, at that time that McK­in­sey was on­ly do­ing con­sult­ing work of an ad­min­is­tra­tive na­ture for the FDA,” Wood­cock said. “Noth­ing to do with any prod­uct or stan­dard or any­thing like that.”

But Has­san ques­tioned her again on McK­in­sey’s track-and-trace work and McK­in­sey’s pub­lic apol­o­gy last year. She al­so ques­tioned why the agency said it’s not reach­ing out to McK­in­sey for fu­ture work, if noth­ing from their past was ir­reg­u­lar. Has­san said she thought this was a ma­jor con­flict of in­ter­est that could’ve fu­eled the opi­oid epi­dem­ic.

Wood­cock has tak­en a lot of heat over the opi­oid ap­provals un­der her watch as CDER di­rec­tor, and it may have con­tributed to her not be­ing nom­i­nat­ed as per­ma­nent com­mis­sion­er (al­though Pres­i­dent Biden has yet to make his nom­i­na­tion).

An­oth­er Dem, Sen. Joe Manchin of West Vir­ginia, pre­vi­ous­ly wrote to Pres­i­dent Joe Biden, ad­vis­ing him not to name Wood­cock as per­ma­nent FDA com­mis­sion­er be­cause of the de­ci­sions she made around opi­oids in the past. “By over­see­ing con­tin­u­ous ap­provals of stronger and more ad­dic­tive opi­oids since the ini­tial ap­proval of Oxy­Con­tin in 1995 – and Dr. Wood­cock has been there for all of it. Dr. Wood­cock has re­peat­ed­ly ig­nored pub­lic health con­cerns and shown a dere­lic­tion of du­ty by not work­ing to end this epi­dem­ic,” Manchin wrote.

In ad­di­tion to McK­in­sey’s opi­oids work, ac­cord­ing to doc­u­ments ob­tained by the House com­mit­tee in its drug pric­ing in­ves­ti­ga­tion, McK­in­sey in Au­gust 2010 al­so ad­vised Ab­b­Vie on ways to block com­pe­ti­tion for its block­buster drug, Hu­mi­ra, which will re­main with­out biosim­i­lar com­pe­ti­tion un­til 2023. McK­in­sey was work­ing close­ly with the FDA’s gener­ic drug of­fice at the time, the com­mit­tee said.

The com­mit­tee is now re­quest­ing that McK­in­sey pro­vide by Nov. 19 a se­ries of doc­u­ments to un­der­stand the full scope of its mon­i­tor­ing fail­ures, con­flicts of in­ter­est, and con­sult­ing.

Among those doc­u­ments will be a de­tailed de­scrip­tion of any mat­ters McK­in­sey has worked on for FDA since 2008 in­volv­ing opi­oids, gener­ic drugs, biosim­i­lar drugs, drug dis­tri­b­u­tion, drug ap­provals, the drug ap­proval process, track-and-trace sys­tems, REMS, or drug safe­ty pro­grams, in­clud­ing the dates, sub­ject mat­ter, work per­formed, and amount FDA paid McK­in­sey for each project.

In ad­di­tion, the com­mit­tee is seek­ing all pre­sen­ta­tions, mem­o­ran­da, re­ports, or oth­er work prod­uct pre­pared for FDA be­tween 2005 and 2021. It al­so re­quest­ed a list of all McK­in­sey con­sul­tants or em­ploy­ees who con­sult­ed or oth­er­wise worked on projects for FDA be­tween 2005 and 2021 and al­so worked on projects for any opi­oid- or phar­ma­ceu­ti­cal-re­lat­ed com­pa­ny at any time dur­ing this pe­ri­od, in­clud­ing but not lim­it­ed to Ab­b­Vie, Am­gen, Cel­gene, Sanofi, Pur­due, En­do, Mallinck­rodt, Janssen, Te­va, Ac­tavis, Amerisource Bergen, McKesson, Car­di­nal Health, CVS, and Wal­mart.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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