Chairman Waxman Requests FDA Provide Documents Regarding Drug Company Marketing Loophole

On January 22, Chairman Waxman wrote to FDA Commissioner von Eschenbach requesting documents related to the FDA’s draft guidance allowing drug companies to use journal articles to promote potentially dangerous off-label uses of drugs and medical devices without prior FDA review and approval. According to FDA minutes of a meeting, Dan Troy and other drug company representatives urged FDA to issue guidance to protect the companies from “Federal prosecutors pursuing distributors of this information for criminal conduct.”