21 U.S.C. § 355b: Adverse-event reporting

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. In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession. The rule shall take effect not later than 60 days after the date on which the rule is promulgated. During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A 1 of the Federal Food, Drug, and Cosmetic Act [ 1 So in original. Probably should be preceded by “section”. 21 U.S.C. 355a ], 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 393a of this title . In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such subcommittee 2 regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act [ 2 So in original. Probably should be “Committee”. 21 U.S.C. 301 et seq.] in response to the report. 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 one-year period described in such paragraph regarding the drug has expired.