Inside the drug promotion legislation

WASHINGTON - Legislation to limit FDA's ability to prohibit manufacturers from disseminating information about unapproved uses of approved drugs, biologicals and medical devices will be completed this week and will be offered as an amendment to legislation reauthorizing the Prescription Drug User Fee Act (PDUFA), according to a congressional aide working on the bill.

The planned legislation, developed by Senators Connie Mack (R-Fla.) and Bill Frist (R-Tenn.), would allow sponsors to disseminate information about off-label uses from peer-reviewed journals and medical textbooks, as defined by the American Medical Association (AMA). Sponsors would have to include the entire article or chapter...