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Testimony revealed Elizabeth Holmes and Theranos issued marketing materials to future partner Walgreens that included the use of Pfizer’s corporate logo despite Pfizer’s decline to partner with the startup blood-testing company...The ongoing criminal trial of Holmes revealed the misrepresentation of Pfizer’s logo...Holmes, along with former Theranos President Ramesh “Sunny” Balwani, were charged with multiple counts of fraud in 2018. According to the charges that the government brought against the duo, from 2013 to 2015, Holmes and Balwani raised more than $700 million from investors for falsely claiming their single-drop blood-testing technology would revolutionize the medical industry...READ MORE

Pharmacy operators including CVS Health Corp and Walmart Inc fueled the U.S. opioid epidemic by failing to stop massive quantities of addictive painkillers from reaching the black market, a lawyer for two Ohio counties said at the start of a trial...Mark Lanier told a federal jury in Cleveland hearing the first trial the pharmacy chains have faced in nationwide litigation over the epidemic that the companies bore responsibility for drug abuse in the counties of Lake and Trumbull..."They just dispensed like a vending machine," Lanier said in his opening statement...READ MORE

A landmark opioid trial is getting underway in Cleveland. For the first time, pharmacies...will be on trial, and there will be far-reaching implications for big-ticket policy questions far afield of the opioid crisis...On one side will be Walgreens, CVS, and Walmart. On the other, two Ohio counties...The basic theory that will be trial-tested is whether pharmacies are legally responsible for creating a public nuisance by overlooking so-called “red flags” when filling customers’ prescriptions for FDA-approved opioids...READ MORE

Sutter Health has agreed to pay the federal government $90 million to settle allegations that it submitted inaccurate information on some of its Medicare Advantage beneficiaries...The settlement, announced by the Department of Justice...comes less than a week after a major $575 million settlement was finalized on allegations the health system overcharged patients. The federal government has been heavily scrutinizing improper coding practices from MA insurers, which experts say is a likely driver of increased Medicare spending...DOJ alleges that Sutter “knowingly submitted unsupported diagnosis codes for certain patient encounters for beneficiaries under its care,”...“These unsupported diagnosis codes caused inflated payments to be made to the plans and Sutter Health.”...READ MORE

...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

The...Supreme Court...cleared the way for New York to collect a $200 million surcharge imposed on opioid manufacturers and distributors to defray the state's costs arising from the deadly epidemic involving the powerful painkilling drugs...The justices declined to hear an appeal by two trade groups representing drug distributors and generic drug makers and a unit of British-based pharmaceutical company Mallinckrodt Plc of a lower court's decision upholding the surcharge...The law's challengers included the Association for Accessible Medicines, whose members include drugmakers Teva Pharmaceutical Industries Plc...and Mallinckrodt, and the Healthcare Distribution Alliance, which represents wholesale distributors...The alliance's members include the three largest opioid distributors in the United States, McKesson Corp, AmerisourceBergen Corp and Cardinal Health...READ MORE

A number of Big Pharma companies, including Gilead and Merck, engaged in what’s known as “pay-for-delay” deals, settling with up-and-coming generic rivals to stall their market entry and costing drug buyers hundreds of millions in lost savings as a result, a handful of high-profile new lawsuits claim...two of the nation’s largest pharmacy chains—CVS and Ride Aid—are going head-to-head with Gilead, Bristol Myers Squibb and Teva for engaging in a “multifaceted scheme to suppress and delay” generic rivals of Gilead’s HIV meds, according to a filing in the U.S. District Court...READ MORE

...the Pharmaceutical Research and Manufacturers of America filed a complaint in the U.S. District Court for the Eastern District of Arkansas challenging provisions in Arkansas Act 1103 that seek to require manufacturers to provide federal 340B program pricing to Arkansas-based pharmacies contrary to federal statute...PhRMA...General Counsel James C. Stansel stated:“The 340B pricing mandate provisions of Arkansas Act 1103 violate both the Supremacy and Commerce clauses of the U.S. Constitution because they impermissibly clash with the statutory requirements of the federal 340B program. This misguided state mandate places requirements on manufacturers that directly conflict with the federal 340B statute and attempts to regulate commercial transactions that occur outside of Arkansas...READ MORE

Pfizer’s efforts to blunt the anti-kickback policies...took a hit...as a federal district court dismissed its plan to assist Medicare patients in paying for one of the company's most expensive drugs...In ruling in favor of the Department of Health and Human Services...New York Judge Mary Kay Vyskocil denied Pfizer clearance to run two programs that would reimburse patients for their pricey heart medications Vyndaqel and Vyndamax, which cost $225,000 annually..."Because...the intent of the payments Pfizer proposes here are to increase the number of Medicare beneficiaries who purchase the drug, the Court is unable to issue the declaratory judgment Pfizer seeks or to issue judgment in its favor," Vyskocil wrote...The fight is an old one for Pfizer. In 2018, it had to cough up $24 million to settle a government lawsuit over donations to patient charities. The recent push was an attempt to challenge the laws that the company previously violated...READ MORE

Bausch Health...has been riddled in controversy for years over its defense of diabetes med Glumetza...the company will pay millions to put those charges to rest...Bausch has agreed to dish out $300 million to settle a 2019 lawsuit that claimed the Canadian drugmaker paid off its generic rivals nearly a decade ago, allowing the company to jack up prices for the type 2 diabetes heavyweight by 800% shortly thereafter...READ MORE