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DOJ Charges The Individual Over Opioid Withdrawal Drug Suboxone Film



A demonstration dose of Suboxone Film, an opioid craving and withdrawal drug marketing by Individual
Photo: M. Spencer Green ( Bloomberg reports that the federal prosecutors on Tuesday sued the British firm, Indivior Plc, the manufacturer of opioid craving and withdrawal drugs Suboxone Film, with misleading doctors and government health programs in thinking that the drug was safer and less addictive than it really is. . According to the U.S. Justice Department, the company even ran a "Here to Help" program that purported to help patients with opioid addiction, when in reality, DOJ says, it directed them to doctors who it knew to have played out loose with scripts.

In a statement, the DOJ claims 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 addiction drug as its Primary ingredient, Indivior marketed Suboxone Film is safer and less likely to end up in the black market than the tablet variety of the drug, with no scientific evidence. Authorities also say Individual then stopped Suboxone production 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." Indiviors made these and other false and misleading claims. In marketing materials and through representations to physicians, pharmacists, and health care benefits programs throughout the country … To further its scheme, Indivior announced a "discontinuance" of its Suboxone tablet form based on alleged "concerns regarding pediatric exposure to" tablets. , when in fact, individual managers knew the main reason for discontinuance was delaying the Food and Drug Administration's approval of generic tablet forms of the drug.

According to the 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 is accused of using an internet- and phone-based progr. m, "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 partly to connect patients the doctors it knew were prescribing Suboxone and other opioids to more patients than permitted by federal law, at high doses, and in suspect circumstances. The indictment claims that Individual executives and employees knew from the statistical and numerous firsthand reports that some of the doctors in the Here to Help referral system issued prescriptions in unreasonable and clinically unwarranted ways.

Procurators say Indivior made "billions" off the scheme; charges include conspiracy to commit fraud, conspiracy to commit mail fraud, and conspiracy to commit fraud in healthcare, as well as one count of healthcare fraud, four pet fraud charges and 22 wire fraud charges. They are asking for forfeitures of at least $ 3 billion.

Individual 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. … 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 The Financial Times reports that over the past year as generic competitors to Suboxone Film have emerged, with shares dropping 73 percent, 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 been motivated by state advocates 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 extremely addictive semisynthetic opioids OxyContin in 1995 and profited to the tune of billions while marketing it as safe, admitted wrongdoing in a 2007 deal 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 opioid overdose-reversing drugs naloxone and "implantable drug pumps to treat opioid addiction" As part of the "end-to-end pain provider" strategy

In March, the paper wrote that several prestigious museums the Sacklers had donated to were beginning to refuse family 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.

[Bloomberg]


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