Aegerion Pharmaceuticals Inc. will plead guilty in the U.S. 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, according to a FDA press release. In connection with this agreement, the criminal information filed 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.
Juxtapid was approved in December 2012 as an adjunct therapy to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic condition in which patients are unable to lower their cholesterol using conventional treatments.
This agreement resolves a criminal investigation in which the FDA’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.
“We sometimes require companies to put in place certain measures to more closely manage a drug’s risks when we don’t believe a medicine’s benefits would outweigh its side effects without these risk mitigation strategies. This might include requiring prescribers to undergo certain training on a drug’s risks, or having providers take steps to more closely monitor patients,” said FDA Commissioner Scott Gottlieb, M.D. “By failing to follow the safety requirements that Aegerion had agreed to, the company put patients’ lives at risk and didn’t honor the safety commitments they made as a condition of gaining approval for their drug.”
Once entered by the court, the plea and consent decree will be part of a global resolution of multiple government investigations into Aegerion’s conduct with respect to the marketing and distribution of Juxtapid. This resolution was the result of a coordinated effort by the U.S. Department of Justice and several government agencies, including the FDA.