Latest FDA Draft Guidance Affirms Continued Government Scrutiny of Risk Information

On May 26, 2009, the US Food and Drug Administration (FDA or Agency) released for public comment a Draft Guidance titled, "Presenting Risk Information in Prescription Drug and Medical Device Promotion" (Draft Guidance). The Draft Guidance has potentially significant implications for pharmaceutical manufacturers with regard to complying with FDA requirements for marketing and promotion of prescription drugs and medical devices and managing litigation risks associated with labeling and promotional activities.

The Draft Guidance outlines the factors FDA will consider when evaluating whether promotional labeling for prescription drugs, advertisements for restricted medical devices, and promotional labeling for all medical devices are consistent with the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA). It also includes examples of promotional practices the Agency finds problematic from a risk communication standpoint. The Draft Guidance does not apply to over-the-counter or "reminder" advertising, which are generally exempted from the heightened risk disclosure requirements imposed on promotional labeling. Stakeholders may submit comments to FDA on the Draft Guidance until August 25, 2009.