Sen­a­tors call on HHS to in­ves­ti­gate McK­in­sey's al­leged ties with FDA, opi­oid man­u­fac­tur­ers

McK­in­sey may be in even deep­er trou­ble than it seemed last year. Last sum­mer, Sen­ate De­moc­rats called on the FDA to look in­to ac­cu­sa­tions that the con­sult­ing firm failed to dis­close po­ten­tial con­flicts of in­ter­est as it worked with both the reg­u­la­to­ry agency and opi­oid man­u­fac­tur­ers at the same time.

Un­sat­is­fied with the an­swers they got, the law­mak­ers are now turn­ing to the HHS’ in­spec­tor gen­er­al for some res­o­lu­tion.

Sev­en US sen­a­tors — led by Sen. Mag­gie Has­san (D-NH) — penned a let­ter to in­spec­tor gen­er­al Christi Grimm on Tues­day call­ing for an in­ves­ti­ga­tion in­to McK­in­sey’s al­leged fail­ure to dis­close con­flict­ing ties to reg­u­la­tors and the opi­oid in­dus­try.

“We al­so write to re­quest that your of­fice re­view FDA’s con­tract­ing poli­cies and pro­ce­dures and de­ter­mine how the agency can en­sure that fu­ture con­trac­tors ad­e­quate­ly dis­close all po­ten­tial con­flicts,” the sen­a­tors wrote.

Since 2008, the FDA has paid McK­in­sey more than $140 mil­lion for a range of work re­lat­ing to opi­oids, drug safe­ty, and drug ap­provals. That in­clud­ed a “track and trace” sys­tem for drugs, mon­i­tor­ing pro­grams to as­sess drug safe­ty, and ways to stream­line the drug ap­proval process.

How­ev­er, re­ports emerged in 2019 that McK­in­sey was al­so con­sult­ing for opi­oid man­u­fac­tur­ers at the same time, in­clud­ing Oxy­con­tin man­u­fac­tur­er Pur­due Phar­ma, the sen­a­tors write. Prop­ub­li­ca re­port­ed in 2021 that McK­in­sey failed to dis­close these ties to the FDA, de­spite be­ing re­quired by con­tract to do so.

When sen­a­tors wrote to the FDA last sum­mer look­ing for an­swers, the agency re­spond­ed that it on­ly learned of McK­in­sey’s ties in ear­ly 2021 from me­dia re­ports.

“FDA has not con­sult­ed McK­in­sey about process­es or re­view is­sues as­so­ci­at­ed with any spe­cif­ic drug prod­uct or spe­cif­ic prod­uct class, in­clud­ing opi­oids. As none of FDA’s con­tracts were specif­i­cal­ly re­lat­ed to opi­oids, no ad­di­tion­al con­tract re­views or out­reach to McK­in­sey oc­curred,” the agency wrote in a let­ter back to the sen­a­tors.

The re­sponse wasn’t enough, law­mak­ers ar­gued in their let­ter on Tues­day, adding that it re­mains “un­clear whether FDA has al­tered or im­proved its process­es and pro­ce­dures to pre­vent sim­i­lar nondis­clo­sures of con­flicts of in­ter­est in fu­ture con­tracts.”

The sen­a­tors al­so ac­cused the FDA of re­turn­ing to McK­in­sey for work even af­ter re­ports of the po­ten­tial con­flict sur­faced, forg­ing new con­tracts worth more than $20 mil­lion be­tween Feb­ru­ary 2019 and Jan­u­ary 2021, ac­cord­ing to the let­ter.

In ad­di­tion to Has­san, the let­ter was signed by Eliz­a­beth War­ren (D-MA), Ed Markey (D-MA), Pat­ty Mur­ray (D-WA), Joe Manchin (D-WV), Shel­don White­house (D-RI) and Tam­my Bald­win (D-WI).

End­points News reached out to McK­in­sey for com­ment, but did not hear back as of press time.

Just over a year ago, McK­in­sey agreed to pay near­ly $574 mil­lion to set­tle claims from 47 states, five ter­ri­to­ries and DC that it helped drug­mak­ers — in­clud­ing Pur­due — ag­gres­sive­ly mar­ket opi­oid painkillers. Plain­tiffs ar­gued that McK­in­sey helped Pur­due de­vise plans to “tur­bocharge” sales un­der a strat­e­gy they called “Evolve 2 Ex­cel­lence,” which sig­nif­i­cant­ly in­creased Oxy­Con­tin sales, ac­cord­ing to court doc­u­ments. McK­in­sey, how­ev­er, main­tained its in­no­cence and the set­tle­ment con­tained no ad­mis­sion of guilt.

“We deeply re­gret that we did not ad­e­quate­ly ac­knowl­edge the trag­ic con­se­quences of the epi­dem­ic un­fold­ing in our com­mu­ni­ties. With this agree­ment, we hope to be part of the so­lu­tion to the opi­oid cri­sis in the U.S.,” McK­in­sey’s glob­al man­ag­ing part­ner Kevin Snead­er said in a state­ment last year.

The House Over­sight Com­mit­tee dug in­to the firm’s close ties to the FDA and opi­oid man­u­fac­tur­ers back in No­vem­ber, re­quest­ing that McK­in­sey pro­vide a se­ries of doc­u­ments to un­der­stand the full scope of its mon­i­tor­ing fail­ures, con­flicts of in­ter­est, and con­sult­ing.

Just last week, a bi­par­ti­san group of sen­a­tors in­tro­duced a bill called the Pre­vent­ing Or­ga­ni­za­tion­al Con­flicts of In­ter­est in Fed­er­al Ac­qui­si­tion Act, which would re­quire fed­er­al con­trac­tors to dis­close po­ten­tial con­flicts of in­ter­est in their busi­ness. The leg­is­la­tion was backed by Sens. Gary Pe­ters (D-MI), Chuck Grass­ley (R-IA), Mag­gie Has­san (D-NH) and Joni Ernst (R-IA).

“At a time when the opi­oid epi­dem­ic is still rag­ing na­tion­wide, we must hold those who fu­eled it ac­count­able and take ac­tion to pre­vent sim­i­lar fail­ures in the fu­ture. We thank you for your prompt at­ten­tion to this mat­ter,” the let­ter reads.

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Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

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Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

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Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Tom Riga, Spectrum Pharmaceuticals CEO

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The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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