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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).

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963