PHILADELPHIA (CN) — Dozens of U.S. states on Friday announced a $102.5 million settlement with the drugmaker behind Suboxone, the brand name for a critical drug used to treat opioid dependence.
In a suit first filed in federal court in Philadelphia in 2016, a group of 41 states led by Wisconsin had accused Virginia-based manufacturer Indivior of conspiring to avoid generic competition for the drug.
The pharmaceutical giant had changed its formulation of Suboxone from a tablet to a dissolving film — a move known as “product hopping,” which artificially inflated prices for the drug in the midst of the country’s growing opioid epidemic.
Indivior denies wrongdoing — but the company nonetheless made major concessions to regulators. It agreed to pay a total of $102.5 million to the states and to file regular reports, including compliance reports concerning any FDA citizen-led petitions involving Suboxone or if the company plans to make any new products.
The U.S. Food and Drug Administration approved Indivior’s Suboxone for sale in the United States in 2002 and gave Indivior the exclusive right to sell the product for the next seven years.
In 2013, just as generic Subloxone tablets received federal approval for sale, the company began selling Suboxone as an oral film instead, ultimately prompting this group of states to sue.
Josh Kaul, Wisconsin’s Democratic attorney general, applauded the settlement in a statement on Friday.
“I’m proud that [the] Wisconsin DOJ led this significant multistate effort and is bringing this case to a successful conclusion,” Kaul said, referring to the Wisconsin’s state-level Department of Justice. “However long it takes, we will continue to hold companies accountable for alleged anticompetitive activities.”
In his own statement on Friday, Indivior CEO Mark Crossley dodged any questions of wrongdoing.
Instead, Crossley said, the company is focused on helping those with substance use disorders.
“We take our role as a responsible steward of medications for addiction and rescue extremely seriously,” he said. “Resolving these legacy matters at the right value allows us to further this mission for patients.”
In 2021, more than 80,000 people in the United States died from opioid-related overdoses, the U.S. Centers for Disease Control and Prevention estimate. Suboxone can be used both as a prescription to treat opioid dependence as well as an “induction agent” that stabilizes an opioid user in withdrawal.
From its filing in 2016, the suit ballooned to involve virtually every other state, including Alabama, Alaska, Arkansas, California, Colorado, District of Columbia, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, West Virginia, and Washington. Washington, D.C. also joined the suit.
This settlement avoids a trial that had been set for September 18, 2023. It still requires final approval from U.S. District Judge Mitchell Goldberg, a George W. Bush appointee and the Philadelphia federal judge overseeing the case.
from Courthouse News
