Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has entered into a settlement agreement with the U.S. Department of Justice (DOJ) to resolve allegations of misconduct related to its multiple sclerosis (MS) therapy, Copaxone. The DOJ had filed a lawsuit in August 2020, accusing Teva of violating the Anti-Kickback Statute and the False Claims Act.
The lawsuit contended that Teva had engaged in a kickback scheme to bolster sales of Copaxone and conspired with other generic drug developers to fix drug prices. It was alleged that Teva illegally paid Medicare co-pays for Copaxone through two charities, The Assistance Fund and Chronic Disease Fund, effectively channeling these kickbacks. A specialty pharmacy, Advanced Care Scripts, which Teva used to refer patients with co-pays, was also implicated in the scheme.
Between May 2023 and December 2015, Teva was accused of three rounds of price manipulation, potentially leading consumers to overpay by at least USD 350 million. The DOJ claimed that from 2007 to 2016, Teva increased the price of Copaxone from approximately USD 17,000 per year to USD 73,000 per year under a so-called “kickback program.”
At the time, U.S. Attorney Andrew E. Lelling for the District of Massachusetts stated that Teva had paid “hundreds of millions of dollars in kickbacks” while “raising the price of its drug, Copaxone, at a rate over 19 times the rate of inflation,” undermining the Medicare program’s co-pay structure.
Previously, in August 2023, Teva reached a USD 225 million deferred prosecution agreement, avoiding exclusion from federal healthcare programs. In the latest settlement, Teva has agreed to pay USD 425 million to resolve the kickback claims and an additional USD 25 million to settle the price-fixing allegations. The settlement does not indicate an admission of liability by Teva or a concession by the U.S. government, as stated in the DOJ’s announcement.- Flcube.com
