Notice to pharma CEOs: Before you appear on television, brush up on your marketing rules. Aegerion Pharmaceuticals ($AEGR) CEO Marc Beer apparently did not, and the FDA has now come calling.
In a warning letter, the agency took Beer to task for exaggerating the benefits of Aegerion's cholesterol drug Juxtapid during an appearance on CNBC's "Fast Money" program. According to the FDA, Beer also made some questionable claims about Juxtapid--enough to suggest that Aegerion was touting the drug for off-label uses. And that's a big no-no.
As TheStreet points out, Juxtapid's FDA approval is based on data showing that the pill lowers cholesterol levels in patients with a rare genetic disease, familial homozygous hypercholesterolemia. The study didn't prove any effects on actual outcomes--a lower risk of heart attack or death, for instance.
But in CNBC interviews, Beer suggested that Juxtapid extended patients' lives, and not just a little bit. Familial hypercholesterolemia is "a devastating disease that causes early death," Beer said on CNBC in June (as quoted in the FDA letter). "And the drug is corrective against that disease and that's the most important thing. ... [T]his product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids."
If reps are out doing the same, then they're marketing the drug off-label, too. And the agency demanded that Aegerion cease and desist--stop using promotional materials that make similar suggestions, stop chatting up doctors with the same statements.
By Nov. 22, Aegerion has to reply to the FDA's letter with a "plan for discontinuing use" of any out-of-bounds promotional materials, "or, in the alternative, your plan to cease distribution of Juxtapid." And because the violations were so serious, Aegerion's response has to include a plan for correcting the bad information it disseminated.
The FDA and the Justice Department have been pretty vigilant about cracking down on off-label marketing. Over the past several years, pharma companies have paid billions in fines and civil penalties for touting their products for unapproved uses. Most recently, Johnson & Johnson ($JNJ) last week agreed to pay $2.2 billion for marketing a variety of drugs off-label, including its powerful antipsychotic drug Risperdal, which it promoted for unapproved use in kids and the elderly.
Beer must not have received that memo, or if he did, he didn't realize that the rules apply to CEOs of small companies, too. In a response to the warning letter, Aegerion told TheStreet that it takes compliance "very seriously" and acknowledges that information about its drugs "needs to be accurate" and balanced. "Our plan is to take quick action in response to the FDA's letter and immediately and effectively address any unsuitable language," the company said. "We appreciate that the FDA's objective is to ensure that promotion is consistent with approved labeling."
Beer isn't the first CEO to find himself in the FDA's off-label woodshed. InterMune ($ITMN) CEO Scott Harkonen was indicted and ultimately convicted for wire fraud in connection with a questionable press release. After the failure of a trial testing Actimmune for a new indication, Harkonen himself wrote a release highlighting some positive data crunched out of that trial--and suggested that the data could lead to a new indication worth $500 million in Actimmune sales. Harkonen has asked the U.S. Supreme Court to consider his case.
Special Reports: Pharma's Top 11 Marketing Settlements | FDA Approvals of 2012 - Juxtapid