Aegerion’s Drug JUXTAPID To Produce Marketing and Sales Data in Response to Federal Subpoena

Announced on January 9, 2014 in a press release found on the Aegerion website, the company received a subpoena from the United States Department of Justice, represented by the U.S. Attorney’s Office in Boston, MA. The subpoena requested the marketing and sales of Juxtapid in the United States.

According to CNBC resources, the subpoena cannot be officially confirmed as a direct connection to the FDA Warning Letter issued in November 2013.

Marc Beer, CEO of Aegerion Pharmaceuticals, Inc. received a warning letter from the FDA regarding an interview on the CNBC’s television show, “Fast Money”.  During the interview that aired June 5, 2013 and October 31, 2013 there were statements that suggested off-label use for JUXTAPID™ (lomitapide) capsules.

In result, Juxtapid could be considered misbranded according to the Federal Food Drug and Cosmetic Act.   Juxtapid is a cardiovascular medication.

Juxtapid is approved only for use as an adjunct to a low-fat diet and other lipid lowering treatments, to reduce specific lipids in patients with HoFH ( homozygous familial hypercholesterolemia) … The approved labeling for Juxtapid does not provide instructions for, or otherwise indicate that Juxtapid will be safe and effective if used, either to reduce the occurrence of cardiovascular events in HoFH patients and to increase their lifespans, or as a stand-alone therapy for reducing lipids in these patients. ~FDA

The FDA continues on to mention that during the interviews the risks of using this drug (intended or approved use) was not mentioned.  Therefore, this suggests that Juxtapid lacks significant risks.  When in fact, the drug has a “Boxed Warning regarding potential liver toxicity, and the product is subject to an associated REMS” (Risk Evaluation and Mitigation Strategy).

Aegrerion Pharmaceuticals, Inc.  had to provide a comprehensive plan of action to the Office of Presciption Drug Promotion (OPDP) on how they were going to retract their misleading statements mentioned in the Warning Letter.  They also requested a list of any promotional materials used to market off-label use of Juxtapid.

Contact our defective pharmaceutical attorneys toll free at (888) 841-9623 if you have experienced negative side effects while taking Juxtapid.