Page:United States Statutes at Large Volume 115 Part 2.djvu/439
PUBLIC LAW 107-109-^AN. 4, 2002 115 STAT. 1423 the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (regardless of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule: (1) The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience. (2) In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession. (3) The rule shall take effect not later than 60 days after the date on which the rule is promulgated. (b) DRUGS WITH PEDIATRIC MARKET EXCLUSIVITY.— (1) IN GENERAL.—During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A of the Federal Food, Drug, and Cosmetic Act, any report of an adverse event regarding the drug that the Secretary of Health and Human Services receives shall be referred to the Office of Pediatric Therapeutics established under section 6 of this Act. In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Subcommittee of the Anti- Infective Drugs Advisory Committee, including obtaining any recommendations of such subcommittee regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act in response to the report. (2) RULE OF CONSTRUCTION. —Paragraph (1) may not be construed as restricting the authority of the Secretary of Health and Human Services to continue carrying out the activities described in such paragraph regarding a drug after the oneyear period described in such paragraph regarding the drug has expired. SEC. 18. MINORITY CHILDREN AND PEDIATRIC-EXCLUSIVITY PRO- GRAM. (a) PROTOCOLS FOR PEDIATRIC STUDIES.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended in subsection (d)(2) by inserting after the first sentence the following: "In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities.". (b) STUDY BY GENERAL ACCOUNTING OFFICE. — 21 USC 355a (1) IN GENERAL.— The Comptroller General of the United note. States shall conduct a study for the purpose of determining the following: (A) The extent to which children of ethnic and racial minorities are adequately represented in studies under section 505A of the Federal Food, Drug, and Cosmetic Act; and to the extent ethnic and racial minorities are not adequately represented, the reasons for such under representation and recommendations to increase such representation.