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...the US Department of Justice, three companies—Taro Pharmaceuticals, Sandoz, and Apotex—have agreed to fork over a total of $447.2m USD to settle their alleged violations of the False Claims Act. According to the government’s allegations, the firms conspired to fix the prices of various generic drugs, resulting in higher prices paid by federal health care programs and beneficiaries...The charges allege that between the years of 2013 and 2015, the trio of companies paid and received compensation, which is prohibited by the Anti-Kickback Statute, via arrangements on price, supply, and allocation of customers with other pharmaceutical manufacturers for certain generic drugs manufactured by the companies...READ MORE

A former pharmacist in Wisconsin who intentionally tampered with more than 500 doses of a COVID-19 vaccine was sentenced to three years in prison on Tuesday. Steven Brandenburg, 46, pleaded guilty in February to two felony counts of attempting to tamper with a consumer product...He had admitted to intentionally removing the doses manufactured by Moderna from a refrigerator for hours at Aurora Medical Center in Grafton, located just north of Milwaukee...READ MORE

A Las Vegas man has pleaded guilty to bilking North Carolina Medicaid out of $13 million, prompting the forfeiture of an airplane, a sports car, a pickup, land and luxury jewelry...Timothy Harron, 52, has pleaded guilty to conspiracy to commit health care fraud, wire fraud, money laundering, and aggravated identity theft. Authorities said the guilty plea requires him to forfeit cash and luxury items...READ MORE

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device...Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan paid bribes and kickbacks to a group of pharmacy benefit managers —referred to collectively as CVS Caremark, Express Scripts, and OptumRx — to ensure that Mylan could raise the price of its EpiPen auto-injector with impunity while also keeping a monopoly share of the market...Mylan and the PBM defendants filed separate motions to dismiss for failure to state a claim...READ MORE

Although Martin Shkreli has been behind bars for years due to a conviction for investment fraud, the man known as “Pharma Bro” has remained active running the former Turing Pharmaceuticals from his jail cell. However, that could change if some activist investors...have their way...Turing is the company that gained infamy after acquiring the decades-old toxoplasmosis drug Daraprim and raising the price by 5,000%. When Shkreli’s Turing Pharmaceuticals acquired Daraprim, the cost of a single pill was about $13.50. Turing increased the price to $750 per tablet, which drastically raises the cost of treatment for patients...READ MORE

An increasing number of American citizens have been apprehended as they have tried to smuggle illegal drugs into the U.S. since the start of the coronavirus pandemic, an uptick that’s come amid travel restrictions at the border with Mexico...the closure of the southern border to nonessential traffic has sharply limited the number of foreign citizens entering the U.S. by land...Law enforcement officials and drug trafficking experts say the border rules — put in place in April 2020 to curb the spread of the coronavirus — and their lopsided enforcement are driving the rise in U.S. citizens involved in borderland drug busts...U.S. citizens were apprehended nearly seven times more often than Mexican citizens between October 2020 and March 31 for trying to smuggle drugs in vehicles, U.S. Customs and Border Protection data shows...READ MORE

Fresenius Kabi Oncology fell afoul of the FDA in 2013 when the agency discovered employees had hidden records before a manufacturing inspection. Now, the drug ingredients manufacturer is admitting fault—and has reached a deal with the U.S. Department of Justice to put the investigation to bed...The Fresenius Kabi unit agreed to pay a $30 million fine, forfeit another $20 million and plead guilty to concealing and destroying records ahead of a 2013 FDA inspection in Kalyani, India...READ MORE

Nevada prison officials...disclosed that they want to use a never-before-tried combination of drugs for the state’s first lethal injection in 15 years, including the powerful opioid fentanyl, the sedative ketamine and a heart-stopping salt, potassium chloride...An execution manual provided to a federal judge ahead of a possible late-July death date for convicted mass killer Zane Michael Floyd said a similar-acting drug, alfentanil, might substitute for fentanyl and potassium acetate might substitute for potassium chloride...U.S. District Judge Richard Boulware II said he may issue a stay of execution by the end of the month to allow time to review the choice of drugs and the 65-page Execution Manual...READ MORE

...Eli Lilly’s COVID-19 drug factory in New Jersey garnered unwanted headlines for quality control snafus and alleged document tampering. Now, the Department of Justice has stepped in to investigate...Lilly revealed the DOJ has issued a subpoena demanding documents relating to the site in Branchburg, New Jersey. The site produces doses of Lilly's COVID-19 antibody treatment, which has recently faced setbacks for its susceptibility to certain variants...In early May, Reuters reported that employees at the site accused an executive of altering FDA-required documents in an effort to downplay serious quality control problems...READ MORE

The U.S. Department of Justice is set to recover more than $3 billion this year from pharmaceutical and medical device manufacturers as well as healthcare providers, labs and pharmacies found guilty of healthcare fraud under the False Claims Act. That figure is based upon settlements that were agreed to but not finalized before the end of 2020, and are the direct result of the DoJ’s investigation into the opioid epidemic...READ MORE