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.

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