A Slip Of The Tongue? FDA Scolds Aegerion CEO For TV Remarks

File this under ‘the ceo should know better.’ Twice this year, Aegerion Pharmaceuticals ceo Marc Beer appeared on the CNBC television show ‘Fast Money’ to discuss Juxtapid, a pill that was approved late last year to treat homozygous familial hypercholesterolemia, a rare and life-threatening form of high cholesterol than can lead to heart attacks and early death. There are about 3,000 people in the US. The $295,000 annual price tag has been controversial, but Aegerion shares have more than quadrupled this year, which made Beer a desirable guest. But someone should have taken some of the profits and paid for media coaching or compliance review before he went on air. Why? The FDA has just issued the drugmaker a warning letter because Beer made statements that rendered Juxtapid misbranded. Specifically, the FDA chastises Beer for making statements during his June 5 and October 31 appearances that suggested Juxtapid prevents heart attacks and can extend lives. The remarks “misleadingly suggest that Juxtapid is safe and effective as a monotherapy. Juxtapid’s labeling limits its use to use as an adjunct to other therapies, and use as a monotherapy is an unapproved use" (here is the FDA letter). As the product labeling notes, “it is not known if Juxtapid is safe in people with high cholesterol, but who do not have HoFH.” And the labeling also says that “it is not known if Juxtapid can decrease problems, such as heart attack, stroke, death or other health problems”...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs