21 U.S.C. § 353c — Prereview of television advertisements

This section lets the FDA review television drug advertisements before they air, though its power to actually force changes is limited. (a) In general. The Secretary may require a drug maker to submit a TV ad — whether it is just a script, storyboard, rough cut, or the finished video — for review, no later than 45 days before it airs. (b) Review. When reviewing the ad, the Secretary may recommend changes to the drug's label information that are either necessary to protect consumers' well-being or that keep the ad consistent with the drug's official prescribing information. If it is appropriate and the information exists, the Secretary may also recommend statements about how well the drug works for specific groups — including elderly people, children, and racial and ethnic minorities. (c) No authority to require changes. Except as subsection (e) allows, the Secretary cannot force or direct the drug maker to actually make any changes to the ad. (d) Elderly populations, children, racially and ethnically diverse communities. When forming recommendations under (b), the Secretary must consider how the advertised drug affects elderly people, children, and racially and ethnically diverse communities. (e) Specific disclosures. Here the Secretary does get real power to require changes, in two situations. If an ad would be false or misleading without a warning about a serious risk listed on the drug's label, the Secretary may require that warning be included. And if an ad would be false or misleading without saying when the drug was approved, the Secretary may require that approval date be disclosed — but only for up to two years after the drug's approval. (f) Rule of construction. Nothing in this section changes the separate label-disclosure requirements in section 352(n), or the Secretary's existing authority under specific FDA advertising regulations (sections 314.550, 314.640, 601.45, and 601.94 of title 21 of the Code of Federal Regulations).