FDA Warns Biogen On Tysabri, Gilead On Truvada Promotions

The Food and Drug Administration said Wednesday a promotional webcast involving the multiple sclerosis drug Tysabri was "false or misleading" because it minimized the risk of a serious brain infection.

Tysabri is sold jointly by Elan Corp. (ELN) and Biogen Idec Corp. (BIIB) to treat multiple sclerosis and Crohn's disease. In a March 25 letter sent to Biogen Idec, the FDA also cited the company for failing to submit the webcast to the agency for review 30 days prior to using the material.

Separately, the agency cited Gilead Sciences Inc. (GILD) for a print advertisement involving its HIV drug Truvada. In a March 26 letter to Gilead, the FDA said the advertisement was "false or misleading" because it overstated the effectiveness of the products and minimized the risks associated with the drug.

Both letters were posted to the FDA's Web site on Wednesday.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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