- U.S. drug agency suspends Louisiana distributor over opioid sales (reuters.com)
...Drug Enforcement Administration said...it had suspended a Louisiana pharmaceutical distributor from selling controlled substances for allegedly selling unusually large quantities of opioids to pharmacies without reporting the sales...Morris & Dickson Co...investigation showed “it failed to properly identify large suspicious orders for controlled substances sold to independent pharmacies with questionable need for the drugs.”...Morris & Dickson filed in federal court...an injunction against the suspension, and U.S. District Judge Elizabeth Foote in Shreveport has scheduled a hearing...on its request for a temporary restraining order...The probe, which focused on purchases of Oxycodone and Hydrocodone, showed that in some cases, pharmacies were allowed to buy as much as six times the quantity of narcotics they would normally order...
- Canadian pharmacy fined $34 million for illegal imports (ktvn.com)
An online pharmacy that bills itself as Canada's largest was fined $34 million...for importing counterfeit cancer drugs and other unapproved pharmaceuticals into the United States...U.S. prosecutors say Canada Drugs' business model is based entirely on illegally importing unapproved and misbranded drugs not just from Canada, but from all over the world. The company has made at least $78 million through illegal imports, including two that were counterfeit versions of the cancer drugs Avastin and Altuzan that had no active ingredient, prosecutors said...judge...approved federal prosecutors' recommended sentences that include $29 million forfeited, $5 million in fines and five years' probation for Canada Drugs...also sentenced Thorkelson (founder, Kris Thorkelson) to six months' house arrest, five years' probation and a $250,000 fine...
- Feds charge 5 doctors over role in alleged Insys bribery scheme (fiercepharma.com)
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...
- “Pharma Bro” Martin Shkreli sentenced to 7 years in prison for fraud (cbsnews.com)You Hate Martin Shkreli. That's Sort Of The Problem (forbes.com)
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.
- FDA chief questions protections on drug rebates, stocks fall (reuters.com)
...Food and Drug Administration chief Scott Gottlieb....questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing...Gottlieb was referring to the common practice of pharmaceutical companies setting a high “list price” for a drug, and then lowering the cost for health plans through hefty rebates in exchange for the broadest access to patients. In recent weeks, he has criticized these practices for keeping drug prices high and locking out competitors...“What if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?”...“Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition.”...The anti-kickback law makes it illegal to pay an incentive for drugs or services that Medicare, Medicaid or other federal healthcare programs cover...
- ‘Pharma bro’ fraudster Martin Shkreli ordered to pay $388,000 in restitution to swindled investor (cnbc.com)
A federal judge...ordered "pharma bro" scammer Martin Shkreli to immediately pay a defrauded hedge fund investor about $388,000 in restitution, roughly half of what the investor asked for… The order comes a month after Judge Kiyo Matsumoto sentenced Shkreli to seven years in prison for defrauding that investor, Richard Kocher, and a number other people, as well as for conspiring to manipulate stock shares...In addition to his prison sentence, Matsumoto also imposed a fine of $75,000 on the 35-year-old Shkreli and ordered him to forfeit almost $7.4 million in assets to the federal government...
- The SEC Says Elizabeth Holmes’ Fraud Was Worse Than Anyone Thought (forbes.com)
Elizabeth Holmes was an even smoother scamster than anyone thought -- and she's apparently getting to keep her job...The SEC just charged the 34-year-old onetime billionaire with fraud related to claims she made about her blood-testing company, Theranos. To settle the charges, Holmes is giving up 18.9 million Theranos shares, losing voting control of the company, paying a $500,000 fine and will be barred from running a public company for ten years. She will, however, continue as the chief executive of Theranos, which under the fraudulent scheme described by the SEC raised $700 million...What emerges from the SEC's complaint is this: ...that Theranos’ sales were much lower than the company had led outsiders to believe. But the SEC puts a fine point on it: At a time when Theranos claimed it had annual sales of $100 million, sales were just $100,000...SEC says Holmes showed...(Walgreens) executives written evidence that Theranos would be able to run just about any blood test on its machines by the end of that year, using drops of blood taken from finger pricks instead of using needles. The next year, the pharmacy executives raised concerns with Holmes that this device might need to be approved by the FDA. But they missed the scale of her deception...Theranos miniLab was supposed to have been rolled out...the machine wasn't ready at all. That's when, (Sunny Balwani) Balwani and Holmes told their engineers to start using other companies' machines in unapproved ways to analyze finger-prick samples, the complaint says. Theranos allegedly never told the pharmacy executives...
- DEA to share prescription drug data with 50 attorneys general, crack down on drugmakers (fiercehealthcare.com)
The Drug Enforcement Agency has reached an agreement with 50 attorneys general to share prescription drug data with one another to support ongoing investigations...from its Automation of Reports and Consolidated Orders System, which collects 80 million prescription drug transactions from manufacturers and distributors each year...Attorney General Jeff Sessions...said the data-sharing pact will “make both the DEA and our state partners more effective at finding evidence of crime.”...Exactly how that data sharing agreement would operate remains fuzzy...
- Swiss drugmaker Novartis faces bribery allegations in China (globaltimes.cn)
A foreign pharmaceutical company has become entangled in bribery allegations in China, in spite of efforts in fighting rampant commercial corruption in the medical sector...An employee at Swiss multinational pharmaceutical company Novartis International AG's affiliate in China (Beijing Novartis Pharma Co., Ltd) accused the drugmaker of money laundering via funding fake academic activities…To promote the company's new drugs such as benazepril and DIOVAN tablets, the company held fake academic activities and paid clinical doctors kickbacks…Novartis...agreed to pay $25 million in 2016 to settle charges that it violated the US Foreign Corrupt Practices Act when its China-based subsidiaries engaged in pay-to-prescribe schemes to increase sales...Novartis said...that the company has launched an investigation into the claim, and promised to take serious measures against any practices that violate rules and regulations...
- Doctor in Insys opioid kickback scheme gets four years in prison (reuters.com)
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...