Healthy Skepticism Library item: 15887
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
FDA Reviews Mailer from Millennium Pharmaceuticals for Velcade
Pharma Live 2009 Jun 24
http://pharmalive.com/news/index.cfm?articleID=635786
Full text:
The FDA posted on its website that it has reviewed a preASCO Donation Mailer (V0948) for
Velcade® (bortezomib) for Injection (Velcade) submitted by Millennium Pharmaceuticals, Inc. According to the FDA, “This mailer is violative because although it has the form of reminder labeling, which is exempted by regulation from the requirements under the Federal Food, Drug, and Cosmetic Act (Act) for the disclosure of risk and other information, for the reasons set forth below, we have determined that your promotional material is not appropriate reminder labeling. In addition, this mailer is false or misleading because it overstates the efficacy of Velcade.” Therefore, the mailer misbrands Velcade in violation of the Act, 21 U.S.C. 352(a) & 321(n), and FDA’s implementing regulations. 21 CFR 201.100(f) & 1.21; cf. 21 CFR 202.1(e)(3)(i), (e)(6)(i) & (e)(6)(xviii).
