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A drug maker will donate $ 1.4 billion to the US government to address allegations that its commercialization would minimize drug abuse risks, the largest single regulation to date for the opioid crisis.
Reckitt Benckiser Group, the maker of Suboxone, a treatment for opioid addiction, has accepted the regulations to stop criminal and civil trade investigations, but has denied any wrongdoing.
The Department of Justice (DOJ) has stated that the British company has illegally marketed Suboxone as less addictive and safer than other drugs containing the same active ingredient and intended to treat opioid withdrawal.
"Withdrawal from opioids is difficult, painful and sometimes dangerous, and people struggling to overcome their addiction face challenges that can often seem insurmountable," said Deputy Attorney General Jody Hunt.
"Manufacturers of drugs that market products to help opioid addicts should do so in an honest and responsible manner."
According to the indictment, a former subsidiary of the company, Indivior Inc., promoted the cinematographic version of Suboxone to doctors, pharmacists and Medicaid administrators as a less abusive drug to treat the drug. opioid withdrawal, which is safer for children, families and communities. other drugs.
Such claims have never been made, the DOJ said.
Indivior has also touted its Internet and telephone program as a resource for opioid-dependent patients, but the DOJ says the program was actually used to connect patients to doctors whom it knew they were prescribing Suboxone to over patients as permitted by federal law.
The group Reckitt Benckiser has denied all wrongdoing in a statement released Thursday.
"RB has always acted lawfully and expressly denies any allegation that it was engaged in unlawful conduct." After careful consideration, RB's board of directors determined that the agreement was in the best interests of the company. the company and its shareholders, "the statement said.
"This avoids the costs, uncertainty and distraction associated with continued investigations, litigation and potential indictment at a time of significant transformation under RB 2.0 and during the CEO's transition."
The regulation only applies to the Reckitt Benckiser group. A trial for Indivior, which was split in 2014, is expected to begin Monday.
Several drug makers are on trial for their alleged role in the epidemic of opioids.
Johnson & Johnson is the subject of a lawsuit in Oklahoma, where the state is seeking $ 17 billion in compensation.
More than 1,200 local governments in the United States sued pharmaceutical companies, and this consolidated case will be heard by a federal court in Ohio.
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