FDA Cites Aegerion for CEO's TV Interview

Source: Pharmaceutical Manufacturing

Nov 19, 2013


The FDA's Office of Prescription Drug Promotion (OPDP) has sent a Warning Letter to the CEO of Aegerion Pharmaceuticals, for his exaggerated and unsubstantiated claims surrounding Aegerion's cholesterol drug, Juxtapid, during an appearance on CNBC's "Fast Money."

Aegerion CEO Marc Beer appeared on CNBC in June and October of this year to discuss Juxtapid. During the interviews, Beer suggested treatment with Juxtapid prevents heart attacks and extends the lives of patients with familial homozygous hyercholesterolemia (HoFH), a rare genetic disease which causes the build up of extremely high levels of cholesterol in the blood.

However, the FDA approved Juxtapid based on clinical trials showing the pill lowers cholesterol levels in HoFH patients only. The studies did not prove Juxtapid reduces the risk of heart attacks or helps HoFH patients live longer.

Unfortunately for Aegerion, the FDA tuned into Beer's Fast Money appearance, and noted that his statements on the appropriate use of the drug did not reflect the drugs risks or limitations, creating the "misleading suggestion that Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes, and increasing the lifespan of patients with HoFH."

Not only did the FDA Warning letter require a response and immediate end to misbranding, but also calls for a "comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to correct any misimpressions about the approved use of Juxtapid.

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