The ads cited in the letters typically appeared as "sponsored links" when a user typed the name of a disease or drug into a search engine. The violations were identified during routine monitoring of Internet advertising conducted by the agency, spokesperson Rita Chappelle said. According to Chappelle, 19 of the 48 drugs cited by FDA carry "black box" warnings, the agency's strongest warning for side effects. In addition, some of the ads included information on uses beyond those approved by the agency.
The letters stated that the companies should remove any ads that include no mention of related health risks and respond to the agency letters this week. The Journal reports that the "warnings marked one of the first major actions by the FDA to crack down on Internet promotion, which is taking a bigger chunk of pharmaceutical marketing budgets" as more people use search engines to seek out information on health problems.
One letter, dated March 26, was sent to Biogen Idec concerning an ad for its multiple sclerosis drug Tysabri that lacked risk information. The letter said that the firm's "casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution." The drug has been linked to serious brain infections in several patients and is subject to sales restrictions intended to reduce the risk of side effects. The ad in question contained a link to a Web site containing relevant risk information, but the agency in its letter wrote that this link "does not mitigate the misleading omission of risk information from these promotional materials." Biogen spokesperson Naomi Aoki said that the firm is working with FDA to resolve the problem and that it takes its responsibility to inform consumers of any risks related to its products "very seriously."
Sanofi-Aventis also received a letter citing ads for its anti-clotting drug Plavix, the world's second-leading drug in terms of sales. According to the letter, "The sponsored links misleadingly suggest Plavix is safer than has been demonstrated."
Other companies receiving letters include Johnson & Johnson, GlaxoSmithKline, Forest Laboratories, Cephalon, Bayer, Novartis, Merck, Eli Lilly, Roche Holding, Genentech and Boehringer-Ingelheim Pharmaceuticals, which recently was acquired by Roche. FDA has not contacted search engines where the ads appeared because its policy is not to contact third parties that carry drug ads, even if they violate agency rules, Chappelle said (Favole, Wall Street Journal, 4/4).
The letters are available online.
