A California-based pharmaceutical company has agreed to pay nearly $96 million to resolve False Claims Act violations for its alleged “false and misleading marketing” of a drug to long-term care providers and paying kickbacks.
Avanir Pharmaceuticals allegedly implemented a strategy to market its drug, Nuedexta, to LTC providers for uses other than what it had been approval for. The drug is cleared by the Food and Drug Administration for the treatment of pseudobulbar affect (PBA). .
The company, however, attempted to get providers to prescribe the drug for behaviors commonly associated with dementia patients, according to the Department of Justice. The DOJ also said the company offered money, honoraria, travel and food to healthcare professionals to persuade them to write prescriptions for the drug.
“Avanir sought to capitalize on efforts by the Centers for Medicare & Medicaid Services to reduce the use of antipsychotics on dementia patients in LTC facilities, based in part on CMS’s concern that antipsychotics can be and have been used as a form of chemical restraint for residents,” the DOJ stated.
Avanir President and CEO Wa’el Hashad said the company is happy to resolve the investigation and is focusing on improving its compliance.
“Avanir is deeply committed to regulatory and legal compliance, integrity and ethical behavior, and the health and safety of patients. Strengthening our culture of compliance has been one of my top priorities since I joined Avanir in 2017. We will ensure that our mission, vision, and values are upheld at every level of our company every day,” Hashad said in a statement.
“We are pleased to resolve this matter, move forward, and continue to develop innovative central nervous system treatments that improve the lives of patients and their care communities.”