Aegerion Resolves Criminal and Civil Actions

Aegerion recently finalized a $40.1 million settlement that resolves civil and criminal charges over its marketing of JUXTAPID®. We previously published an article outlining agreements in principle with the Department of Justice (DOJ) and Securities and Exchange Commission (SEC), following inquiries into the company to determine whether the company’s commercial activities violated laws and regulations. The $40.1 million settlement is split between cases brought by the DOJ and the SEC – with $36 million resolving cases by the DOJ and $4.1 million resolving an SEC lawsuit. Sales representatives were trained to tell doctors and patients that JUXTAPID® would “take patients out of harm’s way” and prevent “impending” heart attacks and strokes, despite the lack of data supporting those claims, prosecutors alleged. On September 22, 2017, Aegerion agreed to plead guilty to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the introduction of misbranded JUXTAPID® into interstate commerce. The criminal information alleged that JUXTAPID® was misbranded because Aegerion failed to comply with the requirements of the JUXTAPID® Risk Evaluation and Mitigation Strategy (REMS) program and because the labeling lacked adequate directions for all of the prescription’s intended uses. The FDA approved JUXTAPID® in 2012 to treat high cholesterol in patients with a rare genetic disease called homozygous familial hypercholesterole...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs