Off-Label Changes Get Congressional Consideration

Congress is looking into making statutory changes to the way FDA governs off-label use of medical products and other pre- and post-marked communications between medical manufacturers, physicians and patients.

A House subcommittee quizzed a panel of experts Wednesday on the possible ramifications of two pieces of legislation that would ostensibly make it easier for medical professionals to get more information about the possible uses of a drug or device directly from its maker—even if those uses are not necessarily intended in the FDA-approved label.

Two separate draft bills by Rep. Morgan Griffith (R-Va.) and Rep. Brett Guthrie (R-Ky.) would seek to carve a path for FDA to provide clarity for drug and device companies regarding dissemination of truthful and non-misleading data and information that is not included in their product labeling.