US authorities seek $3bn penalty in criminal charges against UK opioid makerBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l1777 (Published 11 April 2019) Cite this as: BMJ 2019;365:l1777
The US justice department has brought a felony indictment against the UK drug maker Indivior, alleging that it misrepresented the safety of its sublingual Suboxone Film, an opioid replacement therapy designed to treat addiction.
Indivior developed Suboxone Film in 2007 to replace the Suboxone tablet whose patent was expiring, and it marketed the film as safer to keep around children and harder to misuse or divert—when there was no evidence to support that claim and good reason to suspect the opposite, the indictment alleges.1 Suboxone contains the opioid buprenorphine and the opioid blocker naloxone.
The indictment also alleges that Indivior sought to boost profits with a “Here to Help” scheme, “which Indivior used to connect patients to doctors Indivior knew were prescribing Suboxone and/or other opioids in a careless and clinically unwarranted manner.”
It states that Indivior’s medical director told staff in 2009, as generic competition to the Suboxone tablet threatened to appear, that “we need to develop a story about childhood exposures to set the stage for switching patients [from tablets to film strips].”
To further its scheme, the government alleges, Indivior discontinued its tablet form of Suboxone because of supposed “concerns regarding pediatric exposure” to tablets, when the real purpose was to delay the Food and Drug Administration’s approval of generic tablets by triggering a safety review requirement.
“We could tie up generic for 1 year . . . when we file for film and withdraw tablet,” said one company memo cited in the indictment, explaining the process. “We need to think creatively about a safety story,” said another memo.
In internal communications, the government alleges, Indivior executives doubted that the FDA would support their claim of lower paediatric risk, noting that the film’s individual wrap packaging offered no clear safety benefit over re-closable pill bottles and that, unlike a pill, it could not be spat out.
The FDA did reject the claim, raising those risks and others. The film was also more bioavailable than the tablet, the agency said, leading to potentially higher doses, and it was designed to taste better than the tablet. Its individual wrapping could not be reliably re-closed if parents took out only a partial dose. The paper thin film would also be easier to smuggle and divert, the FDA found.
Nonetheless, the indictment alleges, the company’s marketing plan told sales staff that Suboxone Film was “a more responsible medication from a public health perspective,” was “less divertible/abusable,” and had a “lower risk of child exposure.” Generic tablets would “jeopardize the entire disease space,” the plan claimed.
The UK company, based in Hull, is charged with conspiracy to commit fraud, along with 27 counts of mail fraud, wire fraud, or healthcare fraud. The indictment alleges that Indivior reaped “billions” in profits through fraudulent marketing and asks for fines and penalties totalling at least $3bn (£2.29bn; €2.66bn).
Indivior had set aside $438m in the case and was in talks for a civil settlement when the US government pressed charges. The company’s share price fell 78% within hours, as analysts reported that it lacked the resources to pay such a fine.
“The [justice] department has apparently decided it would rather pursue self serving headlines on a matter of national significance than achieve an appropriate resolution,” Indivior said in a statement, adding that key allegations in the indictment “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.”
At Indivior’s facility in Hull, which opened in 2017, many jobs have already been eliminated in recent months, as its profits and market value fell sharply when generic competitors to Suboxone Film finally appeared last year.