Former FDA counsel analyzes Caronia decision

12/10/2012 | Pharmalot.com

The recent court ruling overturning the conviction of a pharmaceutical sales representative for alleged illegal off-label promotion will not open the floodgates for unchecked off-label promotion, writes Arnie Friede, a former senior corporate counsel with Pfizer and a former FDA associate chief counsel. The decision is binding only in Connecticut, New York and Vermont, many drugmakers are subject to binding settlements regarding off-label promotion, and statements that the FDA deems false and misleading remain open to regulatory action in all states, Friede writes. Considering that the case may make it to the Supreme Court, drugmakers are not likely to begin promoting their drugs off-label, he writes.

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