Posted by Michael Wonder on 22 Sep 2017
Criminal and civil actions filed against Aegerion Pharmaceuticals
22 September 2017 - Today, Aegerion Pharmaceuticals agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce.
In connection with this agreement, the criminal information filed today charged 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 drug’s labelling lacked adequate directions for all of Juxtapid’s intended uses. This agreement resolves a criminal investigation in which the U.S. Food and Drug Administration’s Office of Criminal Investigations played an important role.
