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April 4, 2009, Money Times

FDA warns 14 drug firms over Misleading Internet ads

FDA letter to Bayer

New York: The US Food and Drug Administration has ordered 14 drug makers including Biogen Idec Inc., Pfizer Inc. and Sanofi-Aventis to stop using Internet search engines to promote their major drugs that fail to provide required safety information.
The health watchdog has sent warning letters to the world's 14 leading pharmaceutical companies asking them to pull out what the agency called "misleading" advertisements on Internet search engines.
FDA is accusing the companies for failing to identify product names as well as side effects in sponsored search results. "For promotional materials to be truthful and non- misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug," the agency wrote in one of its letters.
Search engine operators like Google and Yahoo post links to their Web sites in a sidebar and in turn get paid by the drugmakers and interest groups.
FDA spokeswoman Rita Chappelle said the agency found the links as part of its regular supervising of online advertising. She said the U.S. regulators have not contacted any of the search engines that post the ads since the FDA does not contact third-parties that carry ads, even if the ads violate agency rules.
The brief Internet ads accompanying searches on Google and other search engines usually include a headline and blurb about the relevant medical problem or product. These ads pop up as "sponsored links" when someone types a disease name or product name into a search engine.
For instance, Cambridge, Massachusetts-based Biogen's links to its Tysabri Web site come up after searching for information on "multiple sclerosis." One link claims Tysabri is a "multiple sclerosis treatment that's different from the others," but it doesn't mention that the drug is not for all patients or that it may cause deadly brain infections, the FDA wrote in its letter to Biogen on March 26. One more link says "Satisfied with your MS Medication or Looking for Something Different?" but don't include any risk information, according to the agency.
"Their 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 agency said.
Likewise, Sanofi's ads for Plavix, a powerful anti-clotting drug that is the world's second-largest drug by sales, also misleadingly suggest the drug is safer than has been demonstrated, the FDA letter said.
Some of the letters name a company's multiple drugs. For example, a warning letter to Pfizer includes complaints about company's six drugs, including its smoking cessation treatment Chantix and the arthritis medicine Celebrex.
A Pfizer spokesman said the use of Internet to communicate information about diseases and treatments is crucial now-a-days as most of the people use search engines to find out about health problems. He further said that the company will reassess its use of sponsored links to ensure adherence to FDA guidelines. Representatives of the other companies weren't immediately available for comment.
The companies that have received warning letters from FDA are: Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forest Laboratories, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche and Sanofi-Aventis.