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, according to the charges. Aegerion also agreed to a comprehensive compliance program and legal tools for the FDA to ensure that Aegerion complies with the law, subject to judicial oversight.
Rather than following the REMS requirement to distribute Juxtapid only for the narrow indication of homozygous familial hypercholesterolemia, Aegerion portrayed the definition of the rare disorder as vague and indefinite in order to extend its use to lower-risk patients. Further, Aegerion filed a misleading REMS assessment report to the FDA in which the company failed to disclose that it was distributing Juxtapid using this definition, which was inconsistent with Aegerion’s preapproval filings and peer-reviewed clinical standards of diagnosis, according to the FDA release.
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, the press release stated.
Juxtapid was approved in December 2012 as an adjunct therapy to treat homozygous familial hypercholesterolemia. The Juxtapid REMS requires Aegerion to educate prescribers about the risks of hepatotoxicity and the need to monitor patients treated with Juxtapid and to ensure that Juxtapid is prescribed and dispensed only to those patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia.