OPDPIn response to the FDA's warning letter, Aegerion issued the following statement:
FDA's Office of Prescription Drug Promotionrequests that Aegerion immediately cease misbranding Juxtapid and introducing it into interstate commerce for unapproved uses for which it lacks adequate directions. Please submit a written response to this letter on or before November 22, 2013, stating whether you intend to comply with this request, listing any promotional materials (with the 2253 submission date) for Juxtapid that contain statements such as those described above, and explaining your plan for discontinuing use of such materials or, in the alternative, your plan to cease distribution of Juxtapid. Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to correct any misimpressions about the approved use of Juxtapid.
We take regulatory compliance very seriously and acknowledge that our messaging in any setting, including a media interview as in this particular instance, needs to be accurate and fair balanced. Our plan is to take quick action in response to the FDA's letter and immediately and effectively address any unsuitable language. We appreciate that the FDA's objective is to ensure that promotion is consistent with approved labeling, and in that respect we are aligned with the agency.Beer appeared on CNBC June 5 and said about Juxtapid: "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."