How McK­in­sey used its FDA con­nec­tions to help opi­oid man­u­fac­tur­ers: New con­gres­sion­al re­port

Fol­low­ing re­ports that McK­in­sey en­gaged in abu­sive and de­cep­tive busi­ness prac­tices to stoke the flames of the opi­oid epi­dem­ic, the House Over­sight Com­mit­tee on Wednes­day re­leased a new re­port doc­u­ment­ing how the con­sult­ing com­pa­ny lever­aged its work with the FDA to dri­ve new busi­ness with opi­oid man­u­fac­tur­ers.

Doc­u­ments un­cov­ered by the com­mit­tee al­so show how opi­oid jug­ger­naut Pur­due Phar­ma ex­plic­it­ly tasked McK­in­sey with pro­vid­ing ad­vice on how to in­flu­ence the FDA’s de­ci­sions.

“In 2011, at least four McK­in­sey con­sul­tants work­ing on a $1.8 mil­lion FDA con­tract to en­hance drug safe­ty and ad­dress ‘the ad­verse im­pact of drugs on health in the US’ were si­mul­ta­ne­ous­ly work­ing for Pur­due — in­clud­ing on projects de­signed to per­suade FDA of the safe­ty of Pur­due’s opi­oid prod­ucts. One project in­volved writ­ing ‘scripts’ for Pur­due to use in a meet­ing with FDA on the safe­ty of pe­di­atric Oxy­Con­tin,” the 53-page re­port says.

The com­mit­tee’s in­ves­ti­ga­tion al­so un­cov­ered 37 FDA con­tracts that were staffed by at least one McK­in­sey con­sul­tant who si­mul­ta­ne­ous­ly or pre­vi­ous­ly worked for Pur­due, and McK­in­sey failed to dis­close its re­la­tion­ships with opi­oid man­u­fac­tur­ers to FDA.

Many of the de­tails re­gard­ing these un­usu­al re­la­tion­ships be­tween McK­in­sey, FDA and opi­oid man­u­fac­tur­ers are just be­ing un­earthed now, even as they were forged a decade ago.

And while the FDA does not have any cur­rent con­tracts with McK­in­sey, and the con­sult­ing com­pa­ny agreed in Feb­ru­ary to pay $573 mil­lion to 53 at­tor­neys gen­er­al to re­solve al­le­ga­tions that it ag­gres­sive­ly pro­mot­ed the sale of high­er dos­es of opi­oids, the con­gres­sion­al re­port sheds new light on what McK­in­sey did and how it used FDA.

From 2008 to to­day, McK­in­sey worked on 76 con­tracts for the FDA, and the agency has paid McK­in­sey more than $140 mil­lion since 2008, the con­gres­sion­al in­ves­ti­ga­tors found.

At the same time, three se­nior McK­in­sey con­sul­tants — Navjot Singh, Jeff Smith, and Sas­try Chilukuri — worked on mul­ti­ple projects for both Pur­due and FDA.

In the case of Smith, who was “fre­quent­ly cross-staffed” on FDA and Pur­due projects, “One project in­volved the ef­fec­tive­ness of Pur­due’s REMS for Oxy­Con­tin, which was at the time be­ing im­ple­ment­ed by the FDA of­fice Mr. Smith was ad­vis­ing on drug safe­ty,” the re­port says.

Smith lat­er com­plained to Chilukuri that Chilukuri had over­rep­re­sent­ed the ca­pa­bil­i­ties of the FDA’s drug safe­ty track­ing sys­tem, known as Sen­tinel, and that the false claim that Sen­tinel can be “used to as­sess the ef­fi­ca­cy of opi­oids” end­ed up in a speech by for­mer FDA com­mis­sion­er Scott Got­tlieb.

In 2017, Smith al­so be­gan serv­ing as one of the lead McK­in­sey part­ners on a new FDA con­tract, but two days ear­li­er, Smith had start­ed an­oth­er en­gage­ment at Pur­due, at the spe­cif­ic re­quest of Pur­due’s VP of busi­ness, ac­cord­ing to the re­port.

In a state­ment on Wednes­day, McK­in­sey de­fend­ed its pri­or work, not­ing that it stopped ad­vis­ing clients on opi­oid-re­lat­ed busi­ness in 2019:

McK­in­sey’s work for the FDA has fo­cused on ad­min­is­tra­tive and op­er­a­tional top­ics, in­clud­ing im­prove­ments to or­ga­ni­za­tion­al struc­tures, busi­ness process­es and tech­nol­o­gy. We have not ad­vised the FDA on reg­u­la­to­ry de­ci­sions or on spe­cif­ic phar­ma­ceu­ti­cal prod­ucts.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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FDA re­view­ers head back to White Oak in 2023, with lead­er­ship look­ing to ap­pease a new Con­gress

Republicans have taken a stand against the pandemic era habit of lax work-from-home schedules. Now that they’ve wrestled control of the House majority, the FDA’s leadership is playing ball, sending many of the agency’s more than 18,000 employees back to their desks early next year.

Whether this exodus back to White Oak in Silver Spring, MD (many staff will still be allowed to work from home for multiple days per week) will mean more defections to industry and elsewhere remains to be seen.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Bro­ken promis­es? FDA needs more pow­er to re­move drugs from mar­ket­place, JA­MA analy­sis finds

The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to the persistent tension between speed and confidence in early clinical data.

Congress, regulated industry and patients have urged the FDA to shorten the amount of time that the market has to wait for drugs to become available that may help severe and prevalent diseases – and the FDA has listened, offering up a quick accelerated approval pathway that’s frequently used by new cancer drugs.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.