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Civil Plaintiff

Three Generic Pharmaceutical Companies Settle False Claims Act Violations for $447 Million

On October 1, 2021, the United States Department of Justice announced that three generic pharmaceutical manufacturers agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act. The three manufacturers, Taro Pharmaceuticals USA, Inc., Sandoz Inc., and Apotex Corporation were accused of conspiring to fix the price of various generic drugs, which allegedly resulted in higher drug prices for federal health care programs and beneficiaries.

The DOJ alleged that between 2013 and 2015, all three manufacturers paid and received compensation prohibited by the Anti-Kickback Statute, such as making agreements based on price, supply, and allocation of customers with other pharmaceutical manufacturers for certain generic drugs they manufactured.

While the individual settlements are discussed in more detail below, each company also entered into a five-year corporate integrity agreement (CIA) with the Office of Inspector General (OIG). The CIAs include internal monitoring and price transparency provisions that have not been seen before. They also require the common compliance measures, such as risk assessment programs, executive recoupment provisions, and compliance-related certifications from company executives and board members.

Read the source article at policymed.com

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