§353c Prereview of Television Advertisements

Summary

The Secretary can require that any television ad for a drug — including the script, storyboard, rough cut, or finished video — be sent for review at least 45 days before it airs. During the review, the Secretary can recommend changes to the drug’s label info to protect people or to match the product’s prescribing information. The Secretary can also suggest adding statements about how the drug works for specific groups, such as older adults, children, and racial or ethnic minorities, and must consider those groups when making recommendations. The Secretary cannot force changes to the ad materials except as below. If an ad would be untrue or misleading without a specific notice about a serious risk on the drug’s labeling, the Secretary can require that notice. The Secretary can also require the ad to show the drug’s approval date 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. It does not affect requirements under section 352(n) of this title or the Secretary’s authority under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).