Yesterday, on August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that contain product claims. These types of ads must include, among other things, what is often called a “major statement,” i.e., information relating to the advertised drug’s “major side effects and contraindications” in either the audio or the audio and visual parts of the ad. 21 CFR 202.1(e)(1).

In the Federal Register notice, the agency explained that it is considering a new approach to satisfy this requirement called a “limited risks plus disclosure strategy.” Under this approach, the major statement would be limited to 1) “severe (life-threatening), serious, or actionable” risks and 2) a disclosure to alert consumers that there are other risks not included in the ad. The Federal Register notice elaborated on the definitions of “serious” and “actionable” risks.

According to FDA, although some drugs may not have risks that are “severe, serious, or actionable,” all DTC prescription drug broadcast ads that contain products claims must still contain some risk information, because the ads must present a fair balance of risk information when including information concerning a drug’s efficacy. See 21 CFR 202.1(e)(5).

FDA raised specific questions about the new approach, covering issues such as consumer comprehension; criteria for including risks other than “severe, serious, or actionable” risks; distinctions between communicating to patients versus healthcare providers; the impact of the “disclosure” aspect of the approach; how to determine which risk information is material to consumers; and food and drug interactions.

The agency explained that there is concern that major statements in current DTC ads are not providing clear and useful information to consumers. FDA noted that “[s]ome believe” that major statements in DTC ads are too long, which may reduce consumer comprehension, minimize important risk information, and potentially cause patients not to comply with therapy instructions/directions because they fear the drug’s side effects. Conversely, FDA also recognized that ads may omit important information.

This notice follows FDA’s recent announcements regarding risk information research. FDA and RTI International’s Center for Communication Science recently conducted a study on a similar strategy, and it demonstrated that the limited presentation of risks plus the disclosure “improved overall processing” of the ad, as shown by, for instance, better recall and recognition of risk.

FDA has also announced additional plans for studies, and this has been criticized by industry, in part because there is a lack of a clear agenda and the research offers “limited practical utility.”

Comments are requested by November 20, 2017. The Federal Register notice can be accessed here.