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FDA Review of Gleevec Promotional Material
Date: 04/21/2010 (Date of FDA Warning Letter)
Misconduct Type: Health
Enforcement Agency: Health and Human Servs.
Contracting Party: None
Court Type: N/A
Disposition: Investigative Finding
Synopsis: In April 2010, the U.S. Food and Drug Administration issued a warning letter to Novartis Pharmaceuticals Corp. about two websites sponsored by Novartis promoting its cancer treatment drug Gleevec. The FDA found these websites “false and misleading because they promote the drug for an unapproved use, fail to disclose the risks associated with the use of Gleevec and make unsubstantiated dosing claims. Therefore, these websites misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act…and FDA implementing regulations.” It also found that these promotional materials were not submitted to FDA prior to publication in accordance with the law.