Astellas Settles with DOJ for $100 Million Over False Claims Act Allegations
Pharmaceutical company Astellas has agreed to a settlement of $100 million with the US Department of Justice (DOJ) over allegations that it violated the False Claims Act. According to the DOJ, Astellas improperly promoted and marketed its flagship drug, Mycamine, for off-label use, and paid illegal kickbacks to healthcare providers to encourage them to prescribe the medication.
The DOJ’s investigation found that Astellas marketed Mycamine, an antifungal medication, for use in the treatment of pediatric patients with systemic fungal infections. However, the drug was not approved by the FDA for use in children, and Astellas did not conduct any clinical trials to support its safety and efficacy in this population. The company also allegedly promoted Mycamine for use in other off-label indications, including in adult patients with Candida infections.
Furthermore, the DOJ found that Astellas used various means to incentivize healthcare providers to prescribe Mycamine, including paying speaker fees and providing expensive meals and entertainment. This violated the Anti-Kickback Statute, which prohibits such practices.
As part of the settlement agreement, Astellas has admitted to engaging in illegal conduct and will pay $100 million to the federal government and participating states. The company has also agreed to enter into a Corporate Integrity Agreement with the Office of Inspector General (OIG) of the US Department of Health and Human Services, which will require enhanced compliance measures and monitoring.
The Astellas settlement highlights the significant risks associated with off-label marketing and kickback schemes in the pharmaceutical industry. The False Claims Act allows the government to recover damages and penalties from companies and individuals who engage in such illegal conduct, and the DOJ has made it a priority to investigate and prosecute such cases.
As such, pharmaceutical companies must ensure that their marketing and promotional activities are compliant with FDA regulations and that they do not engage in any activities that could be considered kickbacks. Failure to do so could result in significant financial and reputational damage, as well as potential criminal liability.
In conclusion, the Astellas settlement serves as a reminder that compliance with healthcare laws and regulations is of paramount importance for pharmaceutical companies and healthcare providers alike. The government will continue to enforce these laws vigorously, and companies that violate them will face serious consequences.