Loose talk and “Fast Money” can land a CEO in trouble quick. The FDA is accusing a top executive of misbranding the drug Juxtapid during appearances on a CNBC show.
Marc Beer, CEO of Aegerion Pharmaceuticals in Cambridge, Mass., spoke on “Fast Money” June 5 and Oct. 31. According to the FDA, Beer was describing patients with homozygous familial hypercholesterolemia. Juxtapid (lomitapide) has been approved as an adjunct to a low-fat diet and other treatments that lower lipids in this patient population, but its effect on cardiovascular morbidity and mortality have not been determined.
The FDA’s account included statements on June 5 by Beers. “If you can imagine a child having a heart attack at 8, 10, 12 years of age. And then they have another event, usually about every 18 months, and die by the age of 30. And we’ve found out that we can lower it significantly with this drug.”
In another episode he is quoted as saying, “It's a devastating disease that causes early death. And the drug is corrective against that disease … this product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids.”
The agency added that on Oct. 31 he also said, “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.”
The FDA sent a warning letter advising Beer that it considered the statements misleading and that they failed to address risks. The FDA’s Office of Prescription Drug Promotion asked that “Aegerion immediately cease misbranding Juxtapid and introducing it into interstate commerce for unapproved uses for which it lacks adequate directions.”
It set a deadline of Nov. 22 for the pharmaceutical company to reply and include a plan of action to “correct any misimpressions about the approved use if Juxtapid.”