Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid. Aegerion allegedly failed to comply with risk evaluation and management strategies and marketed Juxtapid (which is labeled with a warning about liver toxicity) without proper directions for use.
Aegerion will also pay $40 million to settle claims by the Department of Justice and Securities and Exchange Commission, and enter into a deferred prosecution agreement related to alleged violations of HIPAA. The specific violations of HIPAA have not been made public, but an Aegerion spokesperson stated that it “does not relate to a breach of our privacy or security with respect to patient health information.”