Following a long-running probe, Aegerion Pharmaceuticals has agreed to pay $40 million to settle civil and criminal charges of illegally marketing a pricey cholesterol medicine, failing to adhere to a regulatory safety program, and misleading investors.
Specifically, the company was accused of “unlawfully” marketing Juxtapid, which costs up to $300,000 a year and was approved to treat a rare and inherited form of high cholesterol. The U.S. Department of Justice charged that sales reps were instructed to promote the medicine for treating very high cholesterol more generally, to widen the pool of potential patients and boost sales, but without adequate directions, according to court documents.
Aegerion also failed to comply with the terms of a mandatory regulatory program, known as a Risk Evaluation and Mitigation Strategy, which is designed to ensure the risks of taking a medicine are tracked by doctors and patients. The Juxtapid label carries a serious warning that the drug may cause liver toxicity, and the feds alleged the company failed to file accurate REMS assessment reports with the Food and Drug Administration.