Hot biotech company Aegerion Pharmaceuticals found out the hard way that enthusiastic comments by its CEO about its breakthrough cholesterol drug Juxtapid could lead to unwanted attention from federal drug regulators.
The Food and Drug Administration accused CEO Marc Beer of "misbranding" Juxtapid by claiming it "is intended for new uses, for which it lacks approval and for which its labeling does not provide adequate directions for use," according to an FDA warning letter sent to the Cambridge, Mass.-based company.
The FDA claimed Aegerion made "serious" violations after Beer went too far in his comments in two separate appearances on CNBC's "Fast Money" and left the impression that Juxtapid could be used alone as a treatment for a rare genetic disease and that it could tackle heart conditions, and also that he failed to disclose the potentially serious side effects from the drug.
The company disclosed last Thursday that it had received a Justice Department subpoena for documents relating to Juxtapid's sale and marketing, a revelation that sent the company's stock dropping sharply. It is not clear if that subpoena was spurred by the FDA warning over Beer's "Fast Money" remarks, or not—but the company suggested it was not.
FDA spokeswoman Tara Goodin told CNBC.com in a prepared statement on Monday: "Regardless of the media or venue used to disseminate promotional messages about prescription drugs, pharmaceutical companies undermine the drug approval process and may put the public at risk when they promote drugs for uses that have not been proven safe and effective."
Aegerion in a prepared statement said, "We've taken compliance very seriously since launch. It has always been Aegerion's policy to promote its products only in a manner consistent with the FDA-approved product labeling."
"We plan to cooperate fully with this investigation," the company said. "After meeting with FDA officials regarding the warning letter, we believe we have a path forward to resolve outstanding FDA concerns as articulated in the warning letter. We don't plan to discuss the details of the ongoing government investigation."
However, in an email before that statement was sent, Aegerion spokeswoman Amanda Murphy told a CNBC.com reporter, "I want to be sure you are clear though that we're not certain that the subpoena is related to Marc's statements on 'Fast Money,' and in fact, we believe it likely isn't."
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