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

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

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.

The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Every part of ‘normal’ day-to-day life has been disrupted. Clinical trials and the traditional way of conducting them has been no different. Flexibility became an immediate need for sponsors, CROs, clinical sites, and patients. Quick adjustments had to be made, along with finding new ways to make sure that patients had the appropriate care, oversight of the clinical sites continued to be managed, and drug supply and accountability were maintained. Many clinical sites found themselves acting as a shipping department, trying to make sure all of their patients received their drug safely and on time. CRAs performed remote oversight visits, virtual site tours, and virtual accountability audits. Sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.

For the past 20 years, Novartis and Roche were more than cross-town rivals reigning over towering pharmaceutical dynasties. Novartis also holds a sizable chunk of Roche’s shares — amounting to a nearly one-third voting stake.

Now, Roche is buying that stake back for $20.7 billion.

‘After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment,’ Novartis CEO Vas Narasimhan said in a statement, adding that the cash will go toward purposes in line with current capital allocation.

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After a fiasco surrounding the contamination of Covid-19 vaccine doses in its facilities — during a time in which vaccinating residents was dire to America’s return to normalcy — Emergent BioSolutions’ $600 million manufacturing deal with the US government has come to an end.

CEO Bob Kramer said that the two parties ‘mutually agreed’ to terminate the contract in an earnings call with investors Thursday, evaporating about $180 million in deal value.

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House Democrats are on the cusp of passing two major pieces of Biden’s agenda Friday, but Medicare drug price negotiations — once the centerpiece of the Build Back Better Act’s revenue stream — has been relegated to only about $100 billion in savings over the next decade. That number fell lower yesterday.

Overall, the compromise ended up winning over both Democrat senators receiving PhRMA cash, like Kyrsten Sinema and Bob Menendez, and more liberal senators, like Elizabeth Warren. But on the House side, the battle continued up until yesterday evening.

DeepMind CEO Demis Hassabis

Last summer marked a major breakthrough in drug discovery when DeepMind, a predictive modeling startup from Google parent company Alphabet, offered the most accurate picture yet of the ‘protein folding’ problem. The Alphabet team is now propping up a unit focused solely on drug discovery, and it will look to leverage lessons learned from DeepMind’s example.

Alphabet has launched Isomorphic Labs, a London-based drug discovery startup leveraging the company’s AI and machine learning work, and lessons from DeepMind’s AlphaFold breakthroughs, CEO Demis Hassabis said in a blog post Thursday.

Kate Cronin, Moderna’s first chief brand officer

It’s probably not an exaggeration to say that all eyes in the marketing world are on Kate Cronin. Maybe not specifically on Cronin by name, but most definitely on the Moderna brand she is shepherding as the biotech’s first chief brand officer.

An Ogilvy advertising agency veteran where she was most recently CEO of Ogilvy Health, Cronin has crafted strategies and campaigns for many Big Pharma brands. But Moderna is different. The biotech is not only a newcomer to the public perception stage but also joins with what may be one of the most high-profile product debuts in history. Moderna’s COVID-19 vaccine — its one and only commercial product to date and still under emergency approval — has propelled the company into the white-hot spotlight of consumer opinion and skyrocketed it up the charts of investor estimation.

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Despite a very late line approval for its TKI drug last year, Deciphera has had its eyes set on cracking into earlier patients with GI tumors — a possibility investors cheered. But that door has now been slammed shut, and Deciphera’s cheerleaders are fleeing in droves.

Deciphera’s Qinlock (ripretinib) failed a head-to-head matchup against standard-of-care sunitinib in second-line patients with gastrointestinal stromal tumors (GIST) who had previously been treated with TKI inhibitor imatinib, the biotech admitted Friday.

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The pharma industry owes biotech a thank you note. Driven by innovation from biotech companies including Moderna, BioNTech and Regeneron in Covid-19 vaccines and treatments, the pharma industry is enjoying unprecedented positive public opinion.

The Harris Poll’s most recent data find that 55% of people surveyed rated the pharma industry’s reputation as positive. That’s down slightly from 56% in September and up from 53% in August, but a vast improvement over the industry’s pre-pandemic low point in January 2020 when it sat at 32%.

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Site of bluebird’s new headquarters at 455 Grand Union Blvd, Assembly Row (Photo credit: Aram Boghosian)

Recouping from a series of setbacks for its gene therapy business, bluebird bio successfully bisected itself earlier this week as part of a big rebrand around genetic disease. Now, with its future still in the wind, bluebird has found a new nest.

Bluebird has signed a lease for a new 61,000 square-foot headquarters at Assembly Row in Somerville, MA, that the newly stripped-down biotech envisions as its hybrid home base of the future after spinning off its oncology business earlier this week.

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