By Dara Katcher Levy –
A new Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) suggests that FDA may want a new fight when it comes to the issue of that pesky First Amendment and the interplay with FDA-regulated products.
In a November 8, 2013 Warning Letter, OPDP alleges that statements made by Aegerion Pharmacueticals’ CEO during broadcast interviews on a CNBC talk show, “Fast Money,” constitute evidence of a new, unapproved, intended use for its drug, Juxtapid (lomitapide) capsules. These statements, OPDP alleges, misbrand Juxtapid, making its distribution a violation of the Federal Food, Drug, and Cosmetic Act.
This is the first OPDP Warning Letter that takes issue with an initial broadcast of statements aimed at the financial community, rather than the re-distribution of these materials for purposes of product promotion or as part of a “media pitch” (see our previous post here).
FDA did not cite any of the company’s marketing materials to support its allegation that Aegerion intended a new use for Juxtapid, rather, the focus is solely on the CEO’s statements made as part of the “Fast Money” interviews. Further, OPDP did not cite the traditional statutory provisions relating to false or misleading promotional materials in its Warning Letter; the statutory violation alleged is that the drug is misbranded as its labeling fails to include adequate directions for the new intended use as expressed in statements made by the CEO. Although OPDP makes mention in the Warning Letter that Aegerion’s CEO failed to include risk information as part of the interview, this is unrelated to OPDP’s misbranding allegations relating to the new intended use for the drug.
We are interested to see whether OPDP will be increasing its enforcement focus on investor-related materials and other materials intended for the financial community.