Biogen Receives FDA Warning for Tysabri (re Internet Ads)
FDA Warns Drug Firms Over Internet Ads
WASHINGTON — 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.”
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