World 420_LB_04

Livyra would like to put out a simple direct-to-consumer (DTC) advertisement for Bencontra. In an effort to avoid anything that could be construed as off-label promotion, the DTC advertisement would not include details about what the drug does or who should use it. Livyra is concerned that including the brief summary of risk information described in 21 CFR 202.1(e)(1) would overemphasize risks given that the advertisement would have little or no discussion of benefits. Is the brief summary requi...

Yes, the brief summary of risk information is required for the advertisement of Bencontra.

Prescription drug advertisements are generally required to include a brief summary of risk information (21 CFR 202.1(e)(1)). There are three exemptions to this set out in 21 CFR 202.1(e)(2); the only exemption that is potentially relevant here is the exemption for reminder ads, which are essentially ads that just call attention to the drug's name.

However, under 21 CFR 202.1(e)(1)(i), "Reminder advertisements, other than those solely intended to convey price information including, but not limited to, those subject to the requirements of § 200.200 of this chapter, are not permitted for a prescription drug product whose labeling contains a boxed warning relating to a serious hazard associated with the use of the drug product." In this case, Bencontra's approval letter from the FDA requires a boxed warning for the drug "regarding the increased risk of suicidal thoughts and behaviors in young adults during initial treatment." Accordingly, a reminder advertisement is not permitted for Bencontra.

Given that the advertisement cannot qualify as a reminder ad, none of the exemptions apply, and the Bencontra advertisement must have the brief summary of risk information.