JOURNAL REPRINTS WITH "REFERENCE TO" UNAPPROVED USES WOULD BE ALLOWED UNDER FDA PROMOTION REFORM; TEXTBOOK DISSEMINATION OKAY IF OFF-LABEL USE NOT "HIGHLIGHTED"

Executive Summary

FDA will allow companies to disseminate journal reprints of studies used to support an approved indication that include incidental references to off-label uses, the agency said Nov. 21. "FDA has determined that certain peer-reviewed journal reports upon which FDA relied for approval of a product may be distributed even if they contain information (e.g., reference to unapproved uses) that is inconsistent with the FDA-approved labeling for the product," an agency "Talk Paper" on the reforms states.