Aegerion gets heat from FDA over drug claims

The Food and Drug Administration sometimes spends years investigating the quiet and secretive ways that pharmaceutical companies illegally promote their drugs for uses not approved by the federal agency, whose purpose is to evaluate drugs for safety or at least warn patients of dangerous side effects.

Other times, the FDA need only spend a few minutes watching video online.

The latter was true with Aegerion Pharmaceuticals, which is headquartered in Cambridge, Mass., and whose sole product, Juxtapid, was the result of work by University of Pennsylvania researchers.

The FDA approved Juxtapid on Dec. 21, 2012, to help a very small population of people with deadly levels of high cholesterol, a condition known as homozygous familial hypercholesterolemia (HoFH). But the official label says it must be accompanied by use of other medicine and a low-fat diet. Extra warnings speak of liver toxicity, among other bad side effects. Like many drugs for rare diseases, it has a high price: $295,000 per year.

In June and October, Aegerion chief executive officer Marc Beer was a guest on the CNBC show Fast Money and touted the drug for a slew of things. Trouble is, some of his claims were not true, according to the FDA, which sent an official warning letter to Beer last week, suggesting his comments violated laws restricting drug advertising.

"These patients are going to die of a cardiac event - either a stroke or heart attack - if we don't get them on therapy," Beer said on the Oct. 31 show.

In June, Beer said, in part: "This product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids."

The FDA really did not like the grandkids line, but the agency said that many of Beer's TV comments claimed things not proven by evidence submitted to the FDA and that they ignored the side effects.

"The repeated statements regarding Juxtapid, including claims that patients taking the drug will 'meet their grandchildren,' misleadingly suggest that Juxtapid lacks significant risk," the FDA's Robert Dean wrote in the warning letter, which is available for reading on the FDA website.

In a statement, Beer - who controls 3 percent of company stock - said, "We take regulatory compliance very seriously and acknowledge that our messaging in any setting, including a media interview, as in this particular instance, needs to be accurate and fair, balanced. Our plan is to take quick action in response to the FDA's letter and immediately and effectively address any unsuitable language."