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FDA explains decision not to seek rehearing in Caronia

USA - January 23 2013 Yesterday FDA explained why it did not seek a rehearing of the Second Circuit's December 3, 2012 decision in United States v. Caronia. In its…

Eric Marshall.

Is off-label enforcement off limits?

USA - December 7 2012 On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for off-label uses.

Thomas W. Beimers.

Baker & Daniels' comments on Wyeth v. Levine

USA - March 6 2009 In a decision issued on March 4th, the United States Supreme Court dealt a serious (albeit not entirely fatal) blow to the premise that Federal law, specifically the Food and Drug Administration's approval of label warnings on a prescription pharmaceutical, pre-empts state law claims for failure to adequately warn of risks associated with the use of a drug.

Adrienne Busby.