FDA says Aegerion has satisfied its demands over chatty CEO

Aegerion CEO Marc Beer

Comments by Marc Beer, CEO of Aegerion Pharmaceuticals ($AEGR), got the company slapped with an FDA warning letter for exaggerating the benefits of its cholesterol-lowering drug Juxtapid during a television appearance on CNBC's "Fast Money" program. Beer had nothing to say Wednesday when the company announced the FDA had closed the matter out, satisfied with the "corrective actions" the company had taken.

That honor was given to Martha Carter, chief regulatory officer and senior VP of the Cambridge, MA-based biotech. In a statement she said, "We worked closely with OPDP to resolve the issues raised in the warning letter and are pleased that OPDP considers the matter closed."

The OPDP is the Office of Prescription Drug Promotion, which issued the warning letter last November. The corrective actions included an advertisement on CNBC to deal with the misinformation, the Boston Business Journal reported.

The FDA's approval of Juxtapid was based on data showing that the pill lowers cholesterol levels in patients with a rare genetic disease, familial homozygous hypercholesterolemia. But the study didn't prove the drug actually lowered the risk of heart attack or death. Among the comments the FDA pointed to by Beer was this: "These patients are going to die of a cardiac event, either a stroke or a heart attack, if we don't have them on therapy."

Not only did the comments suggest that "Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes," the FDA said, but they also didn't mention the risks of taking the drug, which include "a boxed warning regarding the risk of hepatotoxicity."

The problems with the FDA are not the only ones the drugmaker faced when it came to marketing Juxtapid. The company said in January that the Department of Justice had issued a subpoena seeking info about marketing the company had done. The company said at the time that it was cooperating. According to the Boston Business Journal, the company has said the two matters were not related. Neither the company, nor Beers, had anything to say today about the DOJ probe.

- here's the announcement
- read the Boston Business Journal story
- check out the FDA warning letter (PDF)

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