Drug and Device Manufacturers Beware: Comments Could Result in FDA Troubles
After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion. The agency asserted that comments made on the show constituted promotional speech and resulted in Aegerion’s cholesterol lowering drug, Juxtapid, being misbranded.
According to the FDA, comments made on Fast Money by Aegerion CEO Marc Beer about Juxtapid “provide evidence that Juxtapid is intended for new uses, for which it lacks approval and for which its labeling does not provide adequate directions for use, which renders Juxtapid misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act)…” The agency also stated that Beer’s comments created a misleading suggestion 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 [homozygous familial hypercholesterolemia].” Finally, it took issue with Beer’s failure to discuss any of the drug’s risks or limitations. The entire Warning Letter can be viewed here.
While the above scenario may be rare, drug manufacturers should take away from this action that statements made by their executives, even if not intended as advertisements or promotional comments, could be considered as such, and ultimately result in the FDA requiring corrective action if such comments are deemed misleading. Here, the agency demanded that Aegerion disseminate “corrective advertising” and send the FDA a “comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages…about the approved use of Juxtapid.”
This incident is just the latest in the FDA’s recent crackdown on any activity it deems “off-label marketing.” Drug manufacturers should be aware that any statements about a drug’s efficacy or use could be targeted for similar action.