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

(a) Toll-free number in labeling. Within one year after January 4, 2002, the Secretary of Health and Human Services had to issue a final rule. The rule requires every drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) — no matter when it was approved — to list on its label the Secretary's toll-free number for reporting drug side effects (adverse events). The label must also say the number is only for reporting, not for medical advice. (1) The rule must set up this labeling requirement in the way most likely to reach the widest group of consumers. (2) When writing the rule, the Secretary must try to keep costs low for the pharmacy profession. (3) The rule must take effect within 60 days after it is issued. (b) Drugs with pediatric market exclusivity. (1) In general. During the one-year period that starts when a drug gets pediatric market exclusivity under section 355a of this title, any adverse event report about that drug that the Secretary receives must go to the Office of Pediatric Therapeutics. The Office's Director must have the Pediatric Advisory Committee review each report, including getting the Committee's recommendations on whether the Secretary should act under the Federal Food, Drug, and Cosmetic Act in response. (2) Rule of construction. Paragraph (1) does not limit the Secretary's power to keep doing this same review of a drug after that one-year period ends.