Waxman Questions Origins, of Off-Label Promotion Guidance

摘要

Rep. Henry Waxman (D-Calif.) is investigating whether drug companies are behind a planned FDA draft guidance that would allow drug and medical device companies to use medical journals to promote off-label uses of their products. Last year, Waxman asked the agency not to release the guidance until it provided further information to the House Oversight and Government Reform Committee, which he chairs (WDL, Dec. 10, 2007). The ban on marketing a product for an unapproved use is a fundamental tenet of drug and device law, Waxman said.