Healthy Skepticism Library item: 8100

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

FDA finalizes guidance on DTC broadcast ads
American Journal of Health System Pharmacy 1999 Sep 15; 56:1815

Abstract:

The final guidance on direct-to-consumer (DTC) advertising of prescription drugs issued by the U.S. Food and Drug Administration (FDA) addressing provision of product labeling is presented; regulations specify that DTC ads must include a statement conveying the product’s most important risk information (adverse effects and contraindications), in addition to either a brief summary or adequate provision for disseminating full product labeling. The final guidance states the following expectations for broadcast advertisements: that they are not false or misleading, that they present a fair balance of information about the drug’s benefits and risks, and that the major statement of risk information and all information about the drug’s approved use are included.