Healthy Skepticism Library item: 13534
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 warning to Pfizer re Viagra video
US Food and Drug Administration 2008 Apr 16
http://www.fda.gov/cder/warn/2008/Viagra-WL.pdf
Abstract:
Dear Mr. Kindler:
The Division of Drug Marketing, Advertising & Communications (DDMAC) of the U.S. Food and Drug-Administration (FDA), through its routine monitoring and surveilance program, has reviewed a direct-to-consumer (DTC) promotional video (video) for Viagra(I (sildenafi citrate) Tablets (Viagra) that appeared on www.cnn.com. The video makes representations about the benefits of Viagra in the treatment of erectile dysfunction but fails to disclose any risk information associated with Viagra.
Therefore, the video misbrands Viagra in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(a) & (n). The video raises public health and safety concerns through its complete ommission of risk information for Viagra by suggesting that Viagra is safer than has been demonstrated…
