§355b Adverse-event reporting

Summary

Within one year after January 4, 2002, the Secretary of Health and Human Services must issue a final rule that makes every drug approved under section 505 show the Secretary’s toll-free phone number on its label. The label must also say the number is only for reporting bad reactions, not for medical advice. The rule must be written so it reaches as many consumers as possible, try to keep pharmacy costs low, and must start no later than 60 days after it is issued. This applies to drugs no matter when they were approved. For the first year after a drug gets market exclusivity under section 505A, any adverse-event report about that drug that the Secretary receives must be sent to the Office of Pediatric Therapeutics. The Office director must have the Pediatric Advisory Committee review the report and get its recommendations on whether the Secretary should take action under the Food, Drug, and Cosmetic Act. The Secretary can still do these reviews or actions after that one-year period ends.