Generics giant Teva Pharmaceuticals will pay $450 million over six years to settle two allegations that the company violated the Anti-Kickback Statute and the False Claims Act, the Department of Justice announced Thursday.
The payout will resolve two matters, one of which the government filed in 2020 accusing Teva of paying Medicare patients’ copays for its blockbuster multiple sclerosis drug Copaxone while simultaneously raising the price of the drug. That case alleged that Teva paid over $300 million to two foundations between 2006 and at least 2015 to cover the copays.
“For far too long, Teva gamed the charitable foundation process by paying kickbacks through two foundations, and with the aid of a specialty pharmacy,” Acting US Attorney for the District of Massachusetts Joshua Levy wrote in a statement. “Those kickbacks undermined the purpose of the Medicare co-pay system and violated the Anti-Kickback Statute.”
A representative for Teva told Endpoints News that the company maintains that its donations to the charities supported patients’ access to Copaxone.
The second accusation, also now settled, is that Teva conspired with other generic drug makers to fix prices for the high cholesterol drug pravastatin, as well as clotrimazole and tobramycin. The company previously settled the criminal side of the accusations with a $225 million financial penalty and an admission that it conspired with three other generic drug manufacturers.
A Teva representative told Endpoints that these recent settlements don’t include an admission of wrongdoing.
“In both matters, Teva disputes that it caused false claims for reimbursement to be submitted to any government programs,” the representative added. “Teva has a strong culture of compliance, and robust controls designed to prevent violations like those alleged in each of these two matters.”