§353c Prereview of Television Advertisements

Summary

The Secretary may require drug makers to send any TV advertisement — including scripts, storyboards, rough cuts, or finished videos — for review at least 45 days before it airs. During that review, the Secretary can recommend label-related changes that are needed to protect consumers or that match the drug’s prescribing information. The Secretary can also suggest adding statements about how the drug works for specific groups, such as elderly people, children, and racial and ethnic minorities, and must think about those groups when making recommendations. The Secretary generally cannot force changes to the submitted ad except as described here. If an ad would be false or misleading without a specific disclosure of a serious risk listed on the label, the Secretary may require that disclosure. The Secretary may also require the drug’s approval date to appear in the ad for up to 2 years after approval under section 355 of this title or section 262 of title 42 if leaving it out would be misleading. Nothing here changes requirements under section 352(n) or the Secretary’s authority under 21 C.F.R. 314.550, 314.640, 601.45, or 601.94.