Exclusive: Bipartisan letter to Merrick Garland warns of opioid overdose drug shortages
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.
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.
“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.