FDA reviewing risk information in drug advertising

FDA said it is considering changes to requirements for communicating risk information in direct-to-consumer advertisements for prescription drugs and biologics, and is opening a public docket to solicit information and comments regarding the proposed changes.

In an unpublished Federal Register notice, FDA said there is concern that drug ads do not provide clear and useful information to consumers and patients under current communication requirements. The agency noted that long-winded statements may result in reduced consumer comprehension, minimization of important risk information, and therapeutic noncompliance. On the other hand, there is also concern that the ads do not include adequate information...