De­mo­c­rat Mar­cy Kap­tur of Ohio joined with Re­pub­li­can Andy Har­ris of Mary­land in pen­ning a new let­ter to At­tor­ney Gen­er­al Mer­rick Gar­land rais­ing fresh con­cerns about the most re­cent opi­oid set­tle­ments that re­quire Te­va Phar­ma­ceu­ti­cals to pro­vide more than $200 mil­lion worth of nalox­one sup­plies to just three states over 10 years, and which might cre­ate short­ages else­where.

Mar­cy Kap­tur

The let­ter, first ob­tained by End­points News, ques­tions what Gar­land’s plans are mov­ing for­ward, es­pe­cial­ly con­sid­er­ing Con­gress pre­vi­ous­ly raised warn­ings in Au­gust 2020 that man­u­fac­tur­ers sup­ply­ing MAT drugs to states at no cost in lieu of pay­ing out their set­tle­ments could cre­ate bot­tle­necks in sup­plies.

“At that time, con­cerns cen­tered on the im­pact of glob­al opi­oid set­tle­ment and FDA re­spond­ed that this would be bet­ter posed to the De­part­ment of Jus­tice (DOJ). These same con­cerns have es­ca­lat­ed in light of re­cent an­nounce­ments that mul­ti­ple states — Flori­da, Rhode Is­land and Texas — are al­low­ing the drug man­u­fac­tur­er to not on­ly pro­vide MAT treat­ment drugs but al­so opi­oid re­ver­sal agents, like nalox­one,” Kap­tur and Har­ris wrote.

Most re­cent­ly, Te­va agreed to pay part of its set­tle­ment with the state of Flori­da by pro­vid­ing gener­ic Nar­can (nalox­one hy­drochlo­ride nasal spray) val­ued at $84 mil­lion (whole­sale ac­qui­si­tion cost) over 10 years. Rhode Is­land’s AG sim­i­lar­ly agreed to a deal where Te­va will sup­ply 50,000 kits of Nalox­one (100,000 nasal sprays) per year for 10 years, val­ued at $62.5 mil­lion, as well as opi­oid treat­ment Sub­ox­one val­ued at $16 mil­lion over 10 years.  And in Texas, the state will get $75 mil­lion worth of Nar­can from Te­va over 10 years.

Andy Har­ris

“The un­in­tend­ed con­se­quences that could re­sult from these mis­guid­ed set­tle­ments are even more con­cern­ing,” the rep­re­sen­ta­tives wrote. “Al­low­ing one com­pa­ny to pro­vide free drugs to en­tire pa­tient pop­u­la­tions is tak­ing a vi­tal­ly im­por­tant choice away from physi­cians and pa­tients. These set­tle­ments span 10 or 15 years, de­pend­ing on the agree­ment, fun­da­men­tal­ly al­ter­ing the mar­ket and sti­fling in­no­va­tion in that space.”

And Kap­tur and Har­ris are ask­ing whether the DOJ has the au­thor­i­ty it needs to as­sess the im­pact that these set­tle­ments will have on the MAT and nalox­one mar­kets.

Mean­while, the FDA may need more con­gres­sion­al au­thor­i­ty to en­sure that opi­oids com­ing to mar­ket are bet­ter than what’s cur­rent­ly avail­able, com­mis­sion­er Rob Califf said at a hear­ing last week.

Sen. Mike Braun (R-IN) agreed that the FDA could use this ad­di­tion­al au­thor­i­ty to rein in opi­oid ap­provals as the cri­sis led to more than 100,000 over­dose deaths in 2021, ac­cord­ing to the CDC.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”