Company Allegedly Lied to Doctors and Public Health Care Benefit Programs About the Safety and Diversion Risks of Suboxone Film
A federal grand jury sitting in Abingdon, Virginia, has indicted Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.) and Indivior PLC (Indivior) for engaging in an illicit nationwide scheme to increase prescriptions of Suboxone Film, an opioid drug used in the treatment of opioid addiction, the Department of Justice announced.
According to the indictment, Indivior obtained billions of dollars in revenue from Suboxone Film prescriptions by deceiving health care providers and health care benefit programs into believing that Suboxone Film was safer, less divertible, and less abusable than other opioid-addiction treatment drugs. Indivior also is alleged to have sought to boost profits by using a “Here to Help” program to connect opioid-addicted patients to doctors the company knew were prescribing opioids at high rates and in a clinically unwarranted manner.
“The deadly opioid epidemic continues to devastate communities and families across our nation,” said Principal Deputy Associate Attorney General Jesse Panuccio of the Department of Justice. “The Department of Justice intends to hold accountable those who are in position to know the harm opioid abuse inflicts, but instead choose to profit illegally from the pain of others. Manufacturers, distributors, pharmacies, and doctors should all be on notice that they must follow the law and act responsibly.”
“Opioid addiction is a national epidemic. 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,” said Assistant Attorney General Jody Hunt. “The Department of Justice is committed to holding opioid manufacturers accountable for such unlawful conduct.”
According to the indictment, Indivior developed Suboxone Film around 2007 as a patent-protected alternative to the tablet form of Suboxone, which was then about to face generic drug competition. The primary ingredient in both Suboxone Film and tablets is buprenorphine, a highly potent opioid. Indivior promoted Suboxone Film as safer and less-divertible than its tablet form, even though the company lacked any scientific evidence to support those claims. In particular, Indivior aggressively marketed Suboxone Film, without an established basis, as having a “lower risk of child exposure” and a “less divertible/abusable formulation.” Indivior made these and other false and misleading claims in marketing materials and through representations to physicians, pharmacists, and health care benefit programs throughout the country. The indictment also alleges that, to further its scheme, Indivior announced a “discontinuance” of its tablet form of Suboxone based on supposed “concerns regarding pediatric exposure to” tablets, when in fact Indivior executives knew the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.
The indictment further alleges that Indivior used its “Here to Help” internet and telephone program as part of its scheme to induce physicians to write prescriptions for Suboxone Film. Touted as a resource for opioid-addicted patients, Indivior used the program in part to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in suspect circumstances. The indictment alleges that Indivior executives and employees knew from statistical and numerous firsthand reports that some doctors in the Here to Help referral system were issuing prescriptions in a careless and clinically unwarranted manner.
Indivior’s scheme, as asserted in the indictment, was highly successful, converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government. Until earlier this year, when Suboxone Film became subject to generic competition, Indivior retained a high portion of the opioid-addiction treatment market.
The indictment charges Indivior with conspiracy to commit wire fraud, mail fraud, and health care fraud. In addition, the indictment charges the company with one count of health care fraud, four counts of mail fraud, and twenty-two counts of wire fraud. An indictment merely alleges that crimes have been committed. All defendants are presumed innocent until proven guilty beyond a reasonable doubt.
“As this case makes clear, our office will aggressively prosecute health care fraud cases and particularly those that target people struggling with opioid addiction,” First Assistant United States Attorney Daniel P. Bubar of the Western District of Virginia said today. “We are grateful for the tireless investigative work of our partners at FDA, Virginia Medicaid Fraud Control Unit, HHS, and the U.S. Postal Service for taking on these types of important investigations.”
“Our indictment alleges a wide-ranging and truly shameful scheme to put profits over the health and well-being of patients trying to manage substance use disorder and opioid dependence,” said Attorney General Mark R. Herring. “It’s incredibly frustrating that while we have been working to remove the stigma around medication-assisted treatment and make it more widely available, Indivior was allegedly conspiring to exploit patients, taxpayers, and the expansion of MAT. My team and I are proud to have helped lead this investigation, and look forward to helping bring it to a just and fair conclusion.”
“Opioid addiction is a public health emergency and medication-assisted opioid treatment options are an important tool for combatting this crisis. This investigation revealed that Indivior tried to mislead FDA and game the system by attempting to bar competition for Suboxone from the market,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs. “We will continue to pursue and bring to justice those who participate in these schemes to the detriment of public health.
The United States Attorney’s Office for the Western District of Virginia and the Department of Justice’s Consumer Protection Branch are prosecuting the case. The case was investigated by the Food and Drug Administration’s Office of Criminal Investigations, the Virginia Attorney General’s Medicaid Fraud Control Unit, Department of Health and Human Services’ Office of the Inspector General, and United States Postal Service Office of Inspector General. Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Western District of Virginia, visit its website at https://www.justice.gov/usao-wdva.
This prosecution is part of a coordinated effort by the Department’s Prescription Interdiction & Litigation (PIL) Task Force to deploy all available criminal, civil, and regulatory tools to hold opioid manufacturers accountable for unlawful practices and to ensure that prescription opioid products are marketed truthfully.
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