April 4th, 2009

FDA Warns Drug Firms Over Internet Ads

By Jared A. Favole
The Wall Street Journal

The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn’t include risk information.

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 because many people use search engines to find out about health problems.

The ads cited by the FDA typically come up as “sponsored links” when people type a disease name or product name into a search engine. Most of the world’s largest pharmaceutical companies were among the 14 that received FDA warning letters.

One letter went to Biogen Idec Inc. over its multiple sclerosis drug Tysabri.

The ads say “A Multiple Sclerosis Treatment That’s Different from the Others” or “Satisfied with your MS Medication or Looking for Something Different?” but don’t include any risk information, according to the FDA.

“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 FDA said in its letter to Biogen on March 26. The letter was posted on the agency’s Web site Friday.

Tysabri has been linked with a serious brain infection in several patients and is marketed under restrictions designed to reduce the risk of the side effect.

The company is working closely with the FDA to resolve the situation, said spokeswoman Naomi Aoki. She said the company takes its responsibility to communicate the risks and benefits of Tysabri “very seriously.”

Biogen’s ad includes a link to the Web site for the drug, which does contain the relevant risk information. The FDA said the link “does not mitigate the misleading omission of risk information from these promotional materials.”

Sanofi-Aventis SA received a warning for ads for Plavix, a powerful anticlotting drug that is the world’s second-largest drug by sales after Pfizer Inc.’s Lipitor. “The sponsored links misleadingly suggest Plavix is safer than has been demonstrated,” the FDA letter said.

The FDA wants the companies to remove the ads that contain violations and respond to the agency next week.

The FDA looked at the ads as part of its routine monitoring of Internet advertising, said agency spokeswoman Rita Chappelle. She said the FDA hasn’t contacted any of the search engines where the ads have appeared because the agency doesn’t contact third parties that carry ads, even if violate agency rules.

Some of the letters include complaints about multiple drugs. For instance, a letter to Pfizer mentions six drugs, including its antismoking drug Chantix and the arthritis medicine Celebrex.

Ms. Chappelle said 19 of the 48 drugs cited in the letters carry the agency’s strongest warning, a black box, about possible side effects.

She said in some instances the information on the ads expanded uses of the drug beyond what they are approved for.

The other companies that received letter are: Johnson & Johnson, GlaxoSmithKline PLC, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc. Genentech was recently acquired by Roche.

A Pfizer spokesman said it is important to communicate information online about diseases and treatments, and 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.

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