Last Updated Apr 7, 2009 3:44 PM EDT
Those cited: Biogen Idec, Sanofi Aventis, GlaxoSmithKline, Forest Laboratories, Cephalon, Bayer, Johnson & Johnson, Pfizer, Novartis , Genentech, Boehringer Ingelheim, Merck, Hoffman-LaRoche, and Eli Lilly. The citations, sent as letters to drug companies, signify that the FDA is no longer going to ignore the online promotion of drugs. For years, the FDA focused its regulatory attention on TV and print ads. While most drug companies have approached the web in a conservative fashion, there have been some outlandish experiments, including online video games. Companies lulled themselves into a false sense of security over the years because their web sites have usually been so much richer than their TV ads. The sites often include all the prescribing information and pages of warnings and side effect descriptions. This level of detail, companies felt, kept them in line with the FDA's requirements for the "fair balance" about drug risks that is required in all advertising.
To the companies' likely chagrin, the FDA has targeted them for the sponsored links they run on Google -- the form of online advertising that is least able to deliver a balance of claims and risks.
Sponsored links usually include only the name of the web site followed by less than a dozen words. In the case of the 14 cited drug companies, those words all contained promotional and efficacy messages -- and none contained risk information.
Bayer's Levitra is an example. When searched in Google, the sponsored link says only:
Poor Blood Flow & ED; Blood Flow May Decrease With High Blood Pressure And May Lead to EDFDA told Bayer:
The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate any risk information associated with the use of these drugs.Pfizer got one for Chantix too:
CHANTIX from Pfizer; Learn about CHANTIX, an aid for smoking cessation treatment.You can download all the letters and screen grabs of the offending ads here.
Ad Age noted that Sanofi-Aventis (cited for a Plavix ad) isn't taking this lying down:
Sanofi-Aventis believes that the links were consistent with DDMAC requirements for the provision of risk information ... The links went to the product-specific website, which contains the important risk information on the landing page and a link to the full prescribing information.It all begs the question: What are companies supposed to have those lines of text say?