Life Sciences

FDA: Gilead rep made misleading statements

Pharma Compliance Alert, March 18, 2009

A Gilead Sciences representative made false or misleading statements about the company’s Letairis drug, according to an FDA warning letter.

A Gilead representative minimized the risks associated with the use of Letairis during the 2008 Pulmonary Hypertension Association International Pulmonary Hypertension Conference and Scientific Sessions in Houston, TX, by misleadingly suggesting that the risks associated with the drug’s risk management plan do not apply to Letairis, the FDA said. As a result of the promotional activity, the drug is misbranded under the Food, Drug, and Cosmetic Act.