Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. have agreed to a settlement with the US Justice Department and pay a $450 million settlement to resolve allegations of violating the Anti-Kickback Statute and the False Claims Act related to price fixing of its Multiple Sclerosis medication Copaxone. The companies, collectively known as Teva, are headquartered in Parsippany, New Jersey, and are the largest generic drug manufacturer in the United States. The settlement amount was determined based on Teva’s financial capacity.
The settlement resolves two alleged kickback schemes. First, Teva agreed to resolve allegations that it violated the Anti-Kickback Statute and the False Claims Act by paying Medicare patients’ copays for Copaxone, a multiple sclerosis drug, from 2006 to 2017. The U.S. alleged that Teva coordinated with third parties to ensure donations to foundations were used to cover copays, which is prohibited by the AKS. Second, Teva USA agreed to resolve allegations that it conspired with other generic drug manufacturers to fix prices for pravastatin, clotrimazole, and tobramycin. Teva USA previously admitted to price-fixing in a criminal case and paid a $225 million penalty. Under the civil settlement, Teva agreed that the benefits it received from price-fixing constituted illegal kickbacks.
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“Kickbacks designed to induce referrals or purchases of healthcare goods or services distort physician and patient decision-making, thwart competition and bypass controls put in place to protect federal health care programs,” said Principal Deputy Assistant US Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department is committed to pursuing those who engage in kickback violations, including drug manufacturers, to ensure that federal health care programs continue to serve the interests of taxpayers and program beneficiaries.”
Copaxone is a brand name for the medication glatiramer acetate. It’s primarily used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Copaxone is an immunomodulator, which means it helps to regulate the immune system. It works by mimicking the proteins found in myelin, the protective coating around nerve fibers. This can help to reduce the immune system’s attack on myelin, which is what causes the damage in MS.
It’s administered as a subcutaneous injection, typically three times a week and has been shown to reduce the frequency of relapses in people with MS.
Common side effects include injection site reactions, flushing, chest pain, and shortness of breath.
