The FDA has issued a Warning Letter to Aegerion Pharmaceuticals, Inc. Chief Executive Officer (“CEO”) Marc Beer for statements Mr. Beer made on CNBC’s stock trading talk show, Fast Money. The Warning Letter alleges that Mr. Beer made statements on Fast Money providing evidence that the drug Juxtapid is intended for new uses for which it lacks FDA approval and for which Juxtapid’s labeling does not provide adequate directions for use. Accordingly, these statements rendered Juxtapid misbranded under the federal Food Drug and Cosmetics Act and made distribution of Juxtapid a violation of the Act. The key issues here are (1) the FDA has targed an individual for (2) public comments made to entice investment.
The Warning Letter provides that Mr. Beer made violative statements on two episodes of Fast Money, airing on June 5, 2013 and October 31, 2013, respectively. On the June 5 episode, Mr. Beer stated that:
In these [homozygous familial hypercholesterolemia (HoFH)] patients, they have a devastating disease. They have a lethal level of cholesterol, bad cholesterol, which we call LDL, going through their blood stream. And they're born with this disease and often not diagnosed until 8, 10 years of age when they have a heart attack. 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. . . . It's a devastating disease that causes early death. And the drug is corrective against that disease and that's the most important thing. If you think about some oncology products that may lengthen life three months or six months, this product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids.
On the October 31 episode, Mr. Beer stated that “[t]hese patients are going to die of a cardiac event, either a stroke or a heart attack, if we don’t have them on therapy.”
Per the Warning Letter, the FDA alleges that Mr. Beer statements misleadingly suggested that “Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes, and increasing the lifespan of patients with HoFH, and thus will have an effect on cardiovascular morbidity and mortality as well as overall mortality” and “that Juxtapid is safe and effective as a monotherapy.” The FDA noted Aegerion Pharmaceuticals had not submitted an application to the FDA demonstrating that Juxtapid is safe and effective for any of these new intended uses. The FDA stated that, in fact, Juxtapid’s approved product labeling specifically includes a limitation of use stating that the effect of Juxtapid on cardiovascular morbidity and mortality has not been determined. Further, the FDA noted that Juxtapid is approved only as an adjunct (i.e., not a monotherapy) to a low-fat diet and other lipid lowering treatments for patients with HoFH.
In addition, the Warning Letter notes that Mr. Beer’s statements failed to communicate any of the risks associated with Juxtapid, including the fact that Juxtapid’s approved product labeling includes a Boxed Warning regarding potential liver toxicity and that Juxtapid is only available under a Risk Evaluation and Mitigation Strategy (“REMS”).
The Warning Letter directs Mr. Beer to “immediately cease misbranding Juxtapid and introducing it into interstate commerce for unapproved uses for which it lacks adequate directions.” Further, Aegerion Pharmaceuticals must submit a comprehensive plan of correction to the FDA.
Given that this Warning Letter was based solely off Mr. Beer’s statements on Fast Money, this could be a signal from the FDA that it intends to keep a more watchful eye on statements made to investors, potential investors, and others in the financial services circuit. Further, this Warning Letter indicates that the FDA monitors oral statements for potential off-label promotion, in addition to printed materials. Historically, Warning Letters are based off printed statements. Warning Letters are often used by the FDA to provide a signal to an industry. The signal here is that the FDA is monitoring oral statements made to the investing community and will take enforcement action against such off-label statements.
This Warning Letter is particularly interesting in light of the December 2012 landmark ruling by the Second Circuit Court of Appeals holding that representatives of pharmaceutical manufacturers, like CEO Mr. Beer in this case, have a First Amendment right to make truthful statements regarding their products, even if such statements promote drugs for uses not approved by the FDA. Pharmaceutical manufacturers have used that ruling this past year to argue for dismissal of claims involving alleged promotion of drugs for off-label uses. The interplay between the FDA’s authority under the Food Drug and Cosmetic Act to prohibit promotion of off-label uses and the First Amendment right to make factually accurate statements regarding a product is in flux and should be carefully monitored as it unfolds in the courts.