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.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.