Aegerion Pharmaceuticals has agreed to pay $40 million and plead guilty to two misdemeanor charges to settle allegations of improperly marketing a pricey cholesterol drug and violating different federal laws.
Specifically, the company failed to market Juxtapid, which costs about $250,000 a year and is used to treat a rare form of high cholesterol, with adequate directions. The settlement, which is still preliminary, also notes that the drug maker failed to comply with the terms of a mandatory program for ensuring that the risks of taking the medicine are followed by doctors and patients.
In a statement released on Thursday announcing the settlement, Aegerion acknowledged obstructing justice concerning the risk management program, and violating both the Health Insurance Portability and Accountability Act and the False Claims Act. The specific nature of the violations was not disclosed.
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Maybe the company should rename itself Juxstupid.
Copy of Warning Letter.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM374338.pdf