Thursday, November 14, 2013
From FDA Law FDA Takes Aim at a Financial Community Broadcast in New Warning Letter 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).
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