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.
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) No authority to require changes
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) Elderly populations, children, racially and ethnically diverse communities
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) Specific disclosures
(1) Serious risk; safety protocol
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) Date of approval
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) Rule of construction
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).
Section was formerly classified to section
353b of this title prior to renumbering by Pub. L. 113–54.
Section effective 180 days after Sept. 27, 2007, see section 909 ofPub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section
331 of this title.
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.
Description of Change
Statutes at Large
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