FDA Reprimands Gilead Over Letairis Statements

Law360, New York (March 9, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has chastised Gilead Sciences Inc. for a sales representative's “false and misleading” statements that misbranded the hypertension drug Letairis and minimized “serious risks” associated with the medication.

In a letter to Gilead posted Thursday to its Web site, the FDA targeted statements made by the unnamed sales representative at a June 2008 international pulmonary hypertension conference in Houston.

Among other things, the agency said the representative stated that a risk management plan for Letairis issued by the FDA was “not...
To view the full article, register now.