Page:United States Statutes at Large Volume 121.djvu/960

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 939

(c) REGULATION OF BIOLOGICAL PRODUCTS.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended— (1) in subsection (a)(2), by adding at the end the following: ‘‘(D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; RISK EVALUATION AND MITIGATION STRATEGY.—A person that submits an application for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, and Cosmetic Act.’’; and (2) in subsection (j), by inserting ‘‘, including the requirements under sections 505(o), 505(p), and 505–1 of such Act,’’ after ‘‘, and Cosmetic Act’’. (d) ADVERTISEMENTS OF DRUGS.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 801(b), is amended— (1) in section 301 (21 U.S.C. 331), by adding at the end the following: ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and (2) by inserting after section 503A the following:

VerDate Aug 31 2005

21 USC 353b.

‘‘(a) IN GENERAL.—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) REVIEW.—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 wellbeing; 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. dkrause on GSDDPC44 with PUBLAW

‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.

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