BOSTON – As part of a landmark settlement between the U.S. Department of Justice and U.K. based pharmaceutical conglomerate Reckitt Benckiser Group regarding opioid marketing practices, Massachusetts is slated to receive $19 million in funds.
The portion is part of a larger $1.4 billion national settlement announced in July, as a result of a federal criminal investigation into the distributors’ marketing practices. The settlement is the largest amount recovered from opioid manufacturers and distributors to date.
The DOJ alleges that Reckitt Benckiser deliberately misled consumers by promoting Suboxone Sublingual Film, a dissolvable film, as a less addictive alternative to Suboxone Sublingual Tablets, as well as being safer for children, families and communities despite neither claim being substantiated.
While Suboxone is an approved treatment used to combat opioid withdrawal, its potential for addiction had been previously acknowledged by both the manufacturer and the FDA.
The settlement also alleges that Reckitt Benckiser knowingly maintained an addiction resource hotline to connect consumers to physicians known to prescribe Suboxone and other opioids at high doses to more patients than allowed by federal law “in a careless and clinically unwarranted manner.” It further alleges the distributor fraudulently claimed to the FDA it had discontinued selling Suboxone Tablets “due to safety concerns” in an attempt to delay the entry of generic competition.
The claims settled by the civil agreement are allegations only. There has been no determination of liability. As part of the settlement, Reckitt Benckiser has agreed not to manufacture, market, or sell any Schedule I, II, or III controlled substances in the U.S. for three years. Suboxone is a Schedule III substance.
“This drug distributor actively and illegally profited from the opioid epidemic and put people’s health at risk,” said Massachusetts Attorney General Maura Healey in a press release. “As we fight the opioid epidemic, our office will hold drug companies accountable for the harm they cause.”
Healey’s investigation into Suboxone abuse resulted in the prosecution of several doctors and medical practices that violated state regulations by requiring cash payments for covered treatment.
Healey's office has yet to confirm whether or not the $19 million settlement will be used to further combat the opioid crisis in Massachusetts.