DRAFT Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion

This draft guidance describes factors FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C 21 Act or the Act) and relevant regulations. The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors. This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk information. The recommendations contained in this draft guidance apply to promotional materials directed to both consumers and healthcare professionals. (Federal Register Notice: See Posted May 13, 2009).