Federal prosecutors on Tuesday indicted British firm Indivior Plc, the manufacturer of the opioid craving and withdrawal drug Suboxone Film, with misleading doctors and government health programs into thinking the drug was safer and less addictive than it really is, Bloomberg reported. According to the U.S. Justice Department, the company even ran a “Here to Help” program that purported to assist patients facing opioid addiction, when in reality, DOJ says, it directed them to doctors it knew played loose with scripts.
In a statement, the DOJ alleged that Indivior developed Suboxone Film in 2007 “as a patent-protected alternative to the tablet form of Suboxone, which was then about to face generic drug competition.” Prosecutors say that despite similarly having buprenorphine, a potent opioid dependence drug, as its primary ingredient, Indivior marketed Suboxone Film as safer and less likely to end up the black market than the tablet variety of the drug, without scientific evidence. Authorities also say Indivior then stopped manufacturing Suboxone under a flimsy pretext to delay regulators from approving generic competitors that would cut into profits. The DOJ writes:
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... 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.
Per NPR, the indictment alleges that Indivior knew the film version was potentially more dangerous and prone to misuse than the tablet version.
Additionally, the DOJ accused Indivior of using an internet- and phone-based program, “Here to Help,” that the company knew was directing patients to doctors who wrote excessive scripts, in violation of federal law:
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.
Prosecutors say Indivior made “billions” off the scheme; charges include conspiracy to commit wire fraud, conspiracy to commit mail fraud, and conspiracy to commit health care fraud, as well as one count of health care fraud, four counts of mail fraud, and 22 counts of wire fraud. They’re asking for forfeitures of at least $3 billion.
Indivior denied the allegations, issuing a statement to Bloomberg saying it was “extremely disappointed” and the case is “wholly unsupported by either the facts or the law. ... We look forward to the full facts coming out in court.” According to the Wall Street Journal, it also accused the DOJ of seeking “self-serving headlines on a matter of national significance.”
The company has been punished by the stock market over the past year as generic competitors to Suboxone Film emerged, with shares dropping 73 percent, the Financial Times reported. More generally, the scale of the opioid crisis—responsible for tens of thousands of deaths a year across the U.S., and with no end in sight—has recently motivated states attorneys general to pursue pharmaceutical companies in court. According to the Times, there are “over 1,600 lawsuits, many of which have been consolidated into a multi-district litigation case due to go to trial in October.”
Purdue Pharma, the company that originally developed the extremely addictive semisynthetic opioid OxyContin in 1995 and profited to the tune of billions while marketing it as safe, admitted wrongdoing in a 2007 plea deal and is still losing major lawsuits. Earlier this month, the New York Times reported that the ongoing litigation against the company uncovered documents from 2014 and 2016 showing that the Sackler family, its owners, discussed profiting off of opioid overdose-reversing drug naloxone and “implantable drug pumps to treat opioid addiction” as part of an “end-to-end pain provider” strategy.
In March, the paper wrote that several prestigious museums the Sacklers had donated to were beginning to refuse the family’s checks, humiliating the pharma clan and leading it to “suspend further philanthropy for the moment.” A major lawsuit brought in New York by a coalition of 500 cities, counties, and Native American tribes has targeted the family directly.