Today, Aegerion Pharmaceuticals Inc. 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 labeling 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.
Aegerion and one of its senior vice presidents, Charles M. Gerrits, PharmD, Ph.D also agreed to enter into a consent decree of permanent injunction with the United States. The consent decree includes a comprehensive compliance program and legal tools for the FDA to ensure that the defendants comply with the law, subject to judicial oversight. The FDA’s Center for Drug Evaluation and Research was instrumental in crafting the compliance obligations agreed to in the consent decree.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577101.htm
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