On top of hun­dreds of law­suits waged by state and lo­cal gov­ern­ments, sev­er­al ma­jor drug­mak­ers and dis­trib­u­tors are now fac­ing a fed­er­al crim­i­nal probe for their role in per­pet­u­at­ing the opi­oid cri­sis.

Fed­er­al pros­e­cu­tors in Brook­lyn are in­ves­ti­gat­ing whether phar­ma com­pa­nies have vi­o­lat­ed the Con­trolled Sub­stance Act — a pro­vi­sion nor­mal­ly re­served for drug deal­ers ac­cord­ing to ex­perts — by in­ten­tion­al­ly al­low­ing their opi­oids to flood com­mu­ni­ties, the Wall Street Jour­nal first re­port­ed. As it turned out, at least six com­pa­nies in­clud­ing J&J, Te­va, Mallinck­rodt, Am­neal and the dis­trib­u­tors McKesson and Amerisource­Ber­gen have dis­closed in re­cent SEC fil­ings that they have re­ceived grand ju­ry sub­poe­nas from the US At­tor­ney’s Of­fice for the East­ern Dis­trict of New York.

John Kapoor In­sys

No­tably, John Kapoor — the founder and for­mer chair­man of In­sys — was con­vict­ed of vi­o­lat­ing the Con­trolled Sub­stances Act but a fed­er­al judge has over­turned that part of his con­vic­tion (leav­ing charges of con­spir­a­cy, wire and mail fraud, for­fei­ture and rack­e­teer­ing in­tact).

Be­tween April and Au­gust of this year, the afore­men­tioned six com­pa­nies were asked to turn over doc­u­ments re­lat­ed to their an­ti-di­ver­sion poli­cies and pro­ce­dures and dis­tri­b­u­tion of their opi­oid med­ica­tion.

J&J and Te­va wrote that they un­der­stand the sub­poe­nas to be “part of a broad­er in­ves­ti­ga­tion in­to man­u­fac­tur­ers’ and dis­trib­u­tors’ mon­i­tor­ing pro­grams and re­port­ing un­der the Con­trolled Sub­stances Act.” The Mallinck­rodt, Am­neal and McKesson fil­ings al­so con­tained ver­sions of the state­ment, while Amerisource­Ber­gen didn’t spec­i­fy the na­ture of the probe.

Crim­i­nal charges, if they were to re­sult from the in­ves­ti­ga­tion, would mark a sig­nif­i­cant es­ca­la­tion in the le­gal tac­tics de­ployed against high-pro­file play­ers ac­cused of fu­elling the opi­oid epi­dem­ic. Ac­cord­ing to the CDC, pre­scrip­tion opi­oids led to 218,000 deaths in the US from 1999 to 2017.

Ear­li­er this year the US At­tor­ney in Man­hat­tan charged Rochester Drug Co­op­er­a­tive, the sixth-largest drug whole­saler in the US, with dis­trib­ut­ing nar­cotics that it knew “were be­ing sold and used il­lic­it­ly” and fail­ing to re­port these im­prop­er us­es to au­thor­i­ties. Two for­mer ex­ecs were al­so in­dict­ed for crim­i­nal of­fens­es.

The of­fice called the case “the first of its kind” as it es­sen­tial­ly charged a phar­ma­ceu­ti­cal dis­trib­u­tor and its ex­ecs for drug traf­fick­ing.

It’s a sig­nif­i­cant de­par­ture from the types of lit­i­ga­tion that opi­oid mak­ers such as Pur­due Phar­ma have faced, in which their ag­gres­sive sales tac­tics were blamed for caus­ing phys­i­cal and fi­nan­cial harm to the plain­tiffs. Pur­due, whose mar­ket­ing strate­gies for Oxy­Con­tin were wide­ly con­sid­ered to have plant­ed mis­con­cep­tions about the ad­dic­tive na­ture of opi­oids across the med­ical com­mu­ni­ty, has filed for bank­rupt­cy as the first step of a $10 bil­lion set­tle­ment that’s still un­der dis­pute.

John Kapoor, the high­est-rank­ing phar­ma ex­ec to be con­vict­ed in an opi­oid-re­lat­ed case so far, was most in­fa­mous for cook­ing up an elab­o­rate scheme to bribe doc­tors — go­ing so far as of­fer­ing lap dances — in­to pre­scrib­ing their pow­er­ful drug for can­cer pain, Sub­sys, to pa­tients who didn’t even have can­cer.

But a ju­ry al­so found him guilty of vi­o­lat­ing the Con­trolled Sub­stances Act. US Dis­trict Court Judge Al­li­son Bur­roughs over­turned it on Tues­day, rul­ing that pros­e­cu­tors had failed to prove that they had the in­tent to dis­trib­ute the drug for non-le­git­i­mate us­es.

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.