FDA Releases Draft Guidance Recommending More Information to Be Included in Some Cases on Labeling of Prescription Drugs and Biological Products

Today, the Food and Drug Administration (FDA) released a draft guidance, “Indications and Usage Section of Labeling for Human Prescription and Biological Products—Content and Format,” describing its recommendations for labeling indications and usage of prescription drugs and biological products. The draft guidance provides examples of circumstances in which an indication that is either broader or narrower than the parameters of the clinical studies supporting approval may be appropriate. While, the FDA is recommending that more information be included on a products label, there is no mention of successful off-label uses. ASCRS will submit comments in response to this draft guidance encouraging the agency to acknowledge potential off-label uses in the labeling indication.