Category:

The case of Insys Therapeutics has played out for several years as suspicions first cropped up in 2014 that the company aggressively marketed its powerful opioid painkiller Subsys, often for off-label uses. Now, the feds have charged five...physicians for taking bribes from the drugmaker in exchange for writing more scripts...In addition to the new complaint, authorities announced that two former Insys employees have taken guilty pleas and are cooperating with the government...doctors Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea face up to 20 years in prison for their alleged participation in the scheme...Allegations against Insys and its former management have been piling up in recent years, and in October, authorities made their way to the company's billionaire founder John Kapoor, charging him with racketeering and other felonies... Prosecutors say the company set up a "speakers bureau" to recruit doctors to write more Subsys scripts, holding "sham" speaking events... the company used the events to funnel money to doctors in exchange for more Subsys scripts, even though many of the prescriptions were outside of the drug's FDA label...

Former pharmaceutical executive Martin Shkreli wept and apologized before being sentenced to seven years in prison...for securities fraud. A U.S. District Court judge in Brooklyn handed down the sentence after a jury in August found him guilty of defrauding investors in his hedge funds...Judge Kiyo Matsumoto said she believed Shkreli to be genuinely remorseful for his crimes, but she expressed concern that a minimal sentence might not deter him in future...The judge...also imposed a $75,000 fine apart from the $7.4 million forfeiture that she...ruled Shkreli must pay.

A Georgia pediatric cardiologist pleaded guilty...wrongfully disclosing information about his young patients to an Aegerion Pharmaceuticals Inc sales representative seeking to identify potential new users of an expensive cholesterol drug...Dr. Eduardo Montana...entered his plea in federal court...Montana pleaded guilty to a misdemeanor charge that he wrongfully disclosed patients’ individual identifiable health information. While he faces up to a year in prison, prosecutors have agreed to recommend a term of probation...According to prosecutors, after Aegerion in 2012 received regulatory approval to market Juxtapid for treating high cholesterol in adults with a rare genetic disease, the drugmaker promoted it for use by patients who lacked the condition...Montana...also disclosed information to a senior Aegerion executive promoting Juxtapid’s off-label uses and provided the sales representative the code to access his electronic medical record system...

Gilead Sciences’ new HIV treatment Biktarvy has been approved by the Food and Drug Administration — but its novel component is also the subject of patent infringement litigation from GSK...Biktarvy is a triple-therapy HIV treatment that brings together bictegravir’s unboosted integrase strand transfer inhibitor with the dual nucleoside transcriptase inhibitor backbone of emtricitabine, tenofovir alafenamide — which are the two components of Gilead’s Descovy...However, now bictegravir is at the center of GSK’s lawsuit, which was filed in the U.S. District Court for the District of Delaware, as well as in Canadian Federal Court in Toronto. GSK’s majority-owned Viiv Healthcare said it is looking to prove that Biktarvy’s use of bictegravir infringes on a patent covering its dolutegravir and other compounds that use dolutegravir’s chemical scaffold. The company said it would seek financial redress...

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments...SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine...in 2016 and 2013 without safety oversight that is routinely performed by the FDA or an institutional review board...The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments…Rational Vaccines has said it considers the 2016 trial a success—though it is unclear what data it used to support that claim...SIU has...acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university.

Martin Shkreli must turn over almost $7.4 million...a judge ruled in a win for prosecutors who say the hedge-fund manager turned pharmaceutical executive cheated his investors...The jailed convict is scheduled to be sentenced March 9 for lying to investors in his hedge funds about his track record and performance as well as a fraud that involved Retrophin Inc., a company he founded...Shkreli had argued that he shouldn’t have to forfeit anything -- or just over $500,000 at the most -- because he didn’t profit from the crimes. Money from his investors went into the stock market, and he didn’t get anything from a plan to control Retrophin shares...Investors ultimately got their money back...Shkreli’s assets -- a Picasso, $5 million in cash in a personal trading account, a one-of-a-kind special edition album by the Wu-Tang Clan, an unreleased Lil Wayne album and shares in Vyera Pharmaceuticals...can be used to fulfill the forfeiture if there’s not enough cash available...

A massive lawsuit over the nation’s opioid crisis has largely ignored an influential group of companies in the prescription drug business...pharmacy benefit managers, these companies secretly make the rules that determine the availability of drugs, and how much patients must pay out of pocket to get them...a community in South Texas is calling PBMs into the fight, filing what its lawyers believe is the first case in the country to name these companies as defendants in a municipal opioid lawsuit...The complaint...was filed in January. And earlier this month it was absorbed into a larger lawsuit in Ohio that aggregates claims from cities and states across the country. That, in turn, could put these companies on the hook nationwide for settlement dollars and court orders meant to change the way the drug industry operates...The county’s suit includes claims against...Express Scripts, CVS Health, and OptumRx — along with two smaller companies that also operate in South Texas, Prime Therapeutics and Navitus Health Solutions...It also includes fraud, conspiracy, and racketeering charges against major drug manufacturers and wholesale distributors, as do many other complaints filed across the country. But Webb County’s case is unusual because of the legal claims and language directed at PBMs, entities the suit calls “the gatekeepers to the vast majority of opioid prescriptions filled in the United States.”

A Rhode Island doctor was sentenced...to more than four years in prison after admitting he took kickbacks from Insys Therapeutics Inc to prescribe its fentanyl-based cancer pain drug to people who did not suffer from the condition...Jerrold Rosenberg...was sentenced by U.S. District Judge John McConnell...who said the doctor effectively sold his medical license to a pharmaceutical company seeking to boost its profits...McConnell said patients were put at risk by Rosenberg, who has admitted the $188,000 Insys paid him in the form of speaker fees were a factor in his decision to write prescriptions for the medication, Subsys...Federal prosecutors...have accused seven former executives and managers at Insys, including billionaire founder John Kapoor, of participating in a scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it...

A coalition of 20 states sued the federal government...over Obamacare, claiming the law was no longer constitutional after the repeal last year of its requirement that people have health insurance or pay a fine...Led by Texas Attorney General Ken Paxton and Wisconsin Attorney General Brad Schimel, the lawsuit said that without the individual mandate, which was eliminated as part of the Republican tax law...Obamacare was unlawful..."The U.S. Supreme Court already admitted that an individual mandate without a tax penalty is unconstitutional," Paxton said in a statement. "With no remaining legitimate basis for the law, it is time that Americans are finally free from the stranglehold of Obamacare, once and for all," ....

The Justice Department said...it will support local officials in hundreds of lawsuits against manufacturers and distributors of powerful opioid painkillers that are fueling the nation's drug abuse crisis...The move is part of a broader effort to more aggressively target prescription drugmakers for their role in the epidemic, Attorney General Jeff Sessions said. The Justice Department will file a statement of interest in the multidistrict lawsuit, arguing the federal government has borne substantial costs as a result of the crisis that claimed more than 64,000 lives in 2016...the Justice Department...which has also sought to crack down on black market drug peddlers and doctors who negligently prescribe...Targets of the lawsuits include drugmakers such as Allergan, Johnson & Johnson, and Purdue Pharma, and the three large drug distribution companies, Amerisource Bergen, Cardinal Health and McKesson. Drug distributors and manufacturers named in these and other lawsuits have said they don't believe litigation is the answer but have pledged to help solve the crisis.