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The US Food and Drug Administration issued 14 untitled letters last week to pharmaceutical companies in violation of the Federal, Food, Drug, and Cosmetic Act for publishing misleading and misbranded information about their drug products online.
The US Food and Drug Administration issued 14 untitled letters last week to pharmaceutical companies in violation of the Federal, Food, Drug, and Cosmetic Act for publishing misleading and misbranded information about their drug products online. FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) found the violations by reviewing various Internet search engines such as Google.com. The primary violation noted was that companies had sponsored links on various websites promoting drugs that did not contain any risk information associated with the drugs’ usage.
The companies cited were: Biogen Idec, Sanofi-Aventis US, GlaxoSmithKline, Forest Laboratories, Cephalon, Bayer Healthcare Pharmaceuticals, Johnson & Johnson Pharmaceutical Services, Pfizer, Novartis Pharmaceuticals, Genentech, Boehringer Ingelheim Pharmaceuticals, Merck & Co, Eli Lilly and Co, and Hoffman-LaRoche.
Other violations were cited as well. The untitled letter to Bayer, for example, also noted that the sponsored links for “YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored links for Mirena overstate the efficacy of the drug. Furthermore, all of the sponsored links fail to use the required established names.” GlaxoSmithKline was cited for omitting risks information for its drugs, Avandia, Avandamet, Avandaryl, Avodart, Coreg CR and Tykerb, four of which have black box warnings.
Under 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i), promotional materials that include the name of the drug product but do not include indications relative to the drug product must disclose risk and other information, according to the GlaxoSmithKline untitled letter.
The exception is reminder advertisements, which note a drug product’s name but do not carry any information about its indication, use, or efficacy.
FDA asked all 14 companies to immediately stop disseminating the violative promotional materials and to submit written response letters to the agency. The untitled letters also suggested the companies review and address any other promotional materials that may have similar violations.