The US Department of Justice said that a federal grand jury sitting in Abingdon, Virginia indicted Indivior for allegedly engaging in an "illicit nationwide scheme" to increase prescriptions of the opioid addiction treatment Suboxone Film (buprenorphine/naloxone). The company, whose shares plunged more than 70 percent on Wednesday, said it will contest the case, noting that the action "is wholly unsupported by either the facts or the law."

Assistant attorney general Jody Hunt remarked "the indictment alleges that, rather than marketing its opioid-addiction drug responsibly, Indivior promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse." If the company is convicted, the government will seek to have it forfeit at least $3 billion.

The indictment claims that the drugmaker obtained billions of dollars in revenue from Suboxone Film prescriptions by deceiving health care providers and health care benefit programmes into believing that Suboxone Film was safer, less divertible and less abusable than other opioid-addiction treatment drugs. Specifically, the indictment alleges that Indivior announced a "discontinuance" of its tablet form of Suboxone due to "concerns regarding paediatric exposure," although the Department of Justice suggested that the primary reason was to delay FDA approval of generic tablet forms of the drug.

Indivior is also alleged to have sought to boost profits by using a "Here to Help" programme to connect opioid-addicted patients to doctors the company knew were prescribing opioids at high rates. The indictment claims that Indivior executives and employees knew from statistical and numerous firsthand reports that some doctors in the programme were issuing prescriptions in a careless and clinically unwarranted manner.

According to the indictment, Indivior's scheme was "highly successful, converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programmes to expand and maintain coverage of Suboxone Film at substantial cost to the government." The charges against the company include conspiracy to commit wire fraud, mail fraud and health care fraud.

In response to the news, Indivior said "key allegations made by the Justice Department are contradicted by the government’s own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong." The drugmaker, which was spun-out from Reckitt Benckiser, added that the Department of Justice "has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution."

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.