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DOJ loads individuals over opioid withdrawal suboxone film



A demonstration dose of Suboxone Film, an opioid strand and withdrawal drug marketing of Indivior.
Photo: M. Spencer Green (19659003) AP)

Federal prosecutors on Tuesday accused British firm Indivior Plc, the manufacturer of the opioid string and the drug Suboxone Film, with misleading doctors and public health programs to believe that the drug was safer and less addictive than it really is, Bloomberg reported. According to the US Department of Justice, the company even ran a "Here To Help" program that claimed to help patients facing opioid dependence, as it is in fact DOJ, instructed them to doctors who knew they were running out of scripts.

In a statement, DOJ claimed that individuals developed suboxone films in 2007 "as a patented alternative to the tablet form of suboxone, which was then in the process of meeting generic drug competition." Prosecutors say that despite having buprenorphine, a potent opioid addiction drug, as a primary ingredient, individuals marketed Suboxone Film as safer and less likely to end up with the black market than the tablet's variation of the drug, without scientific evidence. The government also says Indivior then stopped producing Suboxone under a thin pretense to delay regulators from approving generic competitors who would cut into profits. DOJ writes:

In particular, Indivior aggressively promoted Suboxone Film, with no established foundation, to have a "lower risk of child exposure" and a "less derivative / abusive formulation." Indivior made these and other false and misleading claims in marketing materials and through representations to doctors, pharmacists and health-care programs across the country … To continue the scheme, individuals announced a "discontinuation" of the Suboxone tablet form based on "suspected pediatric exposure concerns". "tablets, as Indivior leaders knew that the primary cause of the deviation was to delay the food and drug administration's approval of generic tablet forms of the drug.

Per NPR alleged that Indivior knew the movie version was potentially more dangerous and abused than the tablet version.

In addition, DOJ Indivior accused of using an internet and phone-based program, "Here to Help", which the company knew was directing patients to doctors who wrote excessive writing, contrary to federal law:

Treated As a resource for opioid-dependent patients, the Indivior program used in part to connect patients to doctors who knew that Suboxone and other opioids were prescribed to more patients than the law by federal law, at high doses and in suspected circumstances. The charge alleges that Indivior's managers and employees knew from statistical and many first-hand reports that some doctors in Here help the referral system issued prescriptions in the careless and clinically unjustified way.

Prosecutors say Indivior has made "billions" of the scheme; Costs include conspiracy to commit fraud, conspiracy to commit fraud and conspiracy to commit fraud in health care, and a plethora of health scams, four counts of fraud and 22 counts of fraud. They are asking for forfeitures of at least $ 3 billion.

Indivior denied the allegations, issued a statement to Bloomberg that said it was "extremely disappointed", and the case is "totally unsupported by the facts or the law. … We look forward to the full facts that come to court." According to the Wall Street Journal, it also accused the DOJ of seeking "self-service headlines in a matter of national importance."

The company has been punished by the stock market over the past year as generic competitors of Suboxone Film appeared, and shares dropped 73 percent reported the Financial Times. More generally, the scope of the opioid crisis – responsible for tens of thousands of deaths a year across the United States, and without end in sight – has recently motivated states attorneys generally pursuing pharmaceutical companies in court. According to the Times, it's "over 1600 lawsuits, many of which have been consolidated into a multi-district case case due to the trial in October."

Purdue Pharma, who originally developed the extremely addictive semi-synthetic opioid OxyContin in 1995 and benefited from tune billions while marketing it as safe, admitted offense in a procedure in 2007 and still loses major lawsuits. Earlier this month, the New York Times reported that the ongoing litigation against the company uncovered documents from 2014 and 2016 that showed that the Sackler family, its owners, discussed using opioid overdose-reversing naloxone and "implantable drug pumps to treat opioid dependence". part of an "end-to-end pain provider" strategy.

In March, the paper wrote that several prestigious museums Sacklers had donated to, began to deny the family controls, humiliate the pharma clan and lead it to "Suspend further philanthropy at the moment." A large lawsuit brought in New York by a coalition of 500 cities, counties and Native American tribes has directed the family directly.

[Bloomberg]


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