§355b Adverse-event Reporting

Summary

The Health and Human Services Secretary must create a final rule within one year after January 4, 2002 that requires every approved drug label to show the Secretary’s toll-free phone number for reporting adverse events and to say the number is for reporting only, not for medical advice. The rule must try to reach as many consumers as possible, try to keep costs low for pharmacies, and must take effect within 60 days after it is issued. If a drug gets pediatric market exclusivity under 505A, then for the one-year period starting when that exclusivity begins, any adverse-event report the Secretary receives about that drug must be sent to the Office of Pediatric Therapeutics. The Office director must have the Pediatric Advisory Committee review the report and offer recommendations on whether to take action under the Federal Food, Drug, and Cosmetic Act. That one-year rule does not stop the Secretary from continuing these activities after the year ends.