§353c — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary may require drug makers to send any TV drug ad (scripts, storyboards, roughs, or finished videos) to the Secretary for review at least 45 days before the ad is shown. During the review, the Secretary can recommend changes to label-related information to protect consumers or to match the product’s prescribing information, and can suggest statements about how well the drug works for specific groups like the elderly, children, or racial and ethnic minorities. The Secretary must consider those groups when making recommendations. The Secretary cannot force changes to the ad except as allowed below. If an ad would be false or misleading without a specific warning about a serious risk listed in the drug’s label, the Secretary may require that warning. The Secretary may also require the ad to show the drug’s approval date for up to 2 years after approval 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.

Title 21, §353c

Food and Drugs — Source: USLM XML via OLRC

(a)The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.

(b)In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug—

(1)on changes that are—

(A)necessary to protect the consumer good and well-being; or

(B)consistent with prescribing information for the product under review; and

(2)if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.

(c)Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).

(d)In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.

(e)(1)In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.

(2)In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 355 of this title or section 262 of title 42, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.

(f)Nothing in this section may be construed as having any effect on requirements under section 352(n) of this title or on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).

Notes & Related Subsidiaries

Editorial Notes

Codification Section was formerly classified to section 353b of this title prior to renumbering by Pub. L. 113–54.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as an

Effective Date

of 2007 Amendment note under section 331 of this title.

§353c Prereview of television advertisements

Summary

Title 21, §353c

Notes & Related Subsidiaries

Editorial Notes

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Citations & Metadata