Aegerion Pharmaceuticals ($AEGR) CEO Mark Beer likes to talk about the company's one and only drug, cholesterol fighter Juxtapid. Maybe a little too much, the FDA said recently in a warning letter about comments he made on television. But Beer has a new audience asking about it, and it is one most CEOs would prefer not to have to face: the Department of Justice.
The Cambridge, MA-based drugmaker on Thursday said it had received a DOJ subpoena seeking info about marketing the company had done, Reuters reports. The company says it is cooperating.
In November, the FDA sent Aegerion a warning letter, saying Beer had overstated the benefits of Juxtapid during an appearance on CNBC's "Fast Money" program. The FDA thought his claims sounded like he was suggesting off-label uses, something that has gotten lots of other companies into legal entanglements.
Juxtapid was approved in December 2012 to lower the cholesterol levels in patients with a rare genetic disease, familial homozygous hypercholesterolemia, but study data didn't show any actual outcomes, like lowering the risk of heart attacks, for example. Beer, however, told the television audience that it had the potential to extend the lives of patients, "of taking a patient that would die at 30 and allow them to meet their grandkids."
The FDA demanded that Aegerion cease and desist, to not make those kinds of statements to doctors or use any promotional materials that make similar suggestions. It said the company either had to submit a plan for changing up the sales approach or cease selling the drug. Now, the DOJ wants to review just what kind of claims were made. The company said it would respond ASAP to FDA concerns an "immediately and effectively address any unsuitable language." But now the DOJ wants to know how the company has been marketing the product.
The FDA and Justice Department take these matters very seriously. In fact, a DOJ official last year warned the industry that despite a court ruling about the "free speech" aspect of such claims, the DOJ intended to pursue off-label marketing aggressively. Settlements for touting drugs for off-label uses have cost pharma companies billions. Just ahead of Aegerion getting its FDA letter, Johnson & Johnson ($JNJ) agreed to pay $2.2 billion for marketing a variety of drugs off-label, like its antipsychotic drug Risperdal, which it promoted for unapproved use in kids and the elderly.
Sometimes it can be even worse for talky CEOs. InterMune ($ITMN) CEO Scott Harkonen was convicted for wire fraud for writing a press release that hyped the company's Actimmune for a new indication it wasn't approved for. His conviction has been appealed to the U.S. Supreme Court.
- here's the Reuters story