§355c–1 Report

Summary

The Secretary must write a public report about how the rules in sections 355a and 355c are being carried out. The first report was due no later than four years after July 9, 2012, and then a new report must be made every five years. The report must be sent to two Congressional committees and put on the FDA website. The report must say if the rules are helping doctors and families know more about medicine for children. It must list the number and types of labeling changes since July 9, 2012. It must count studies that missed deadlines and explain deferrals, deferral extensions, waivers, and letters issued. It must report problems with pediatric study plans and how many plans were late. It must give counts of written requests issued, accepted, and declined since July 9, 2012, and any gaps from declined requests. It must describe referrals under 355a(n), assess studying biological products (including 42 U.S.C. 284m), report efforts and results to increase studies in newborns, and count and describe pediatric cancer drug testing and any recommendations (with reasons). It must recommend ways to improve pediatric drug research and labeling, assess rare disease studies, and evaluate effects of the FDA Reauthorization Act of 2017 (including compliance with deferral deadlines). It must report on efforts under section 505C–1, including average times and counts for completing studies and adding labeling, responding to proposed pediatric study requests, issuing written requests, how many written requests were issued before applications, and the number and timing of written-request amendments. It must list sponsors who got exclusivity after an early letter, list required assessments and investigations under 355c, report requests and completions for targeted cancer drugs approved prior to 3 years after August 18, 2017, assess effects of section 504 of the FDA Reauthorization Act of 2017 and give any recommendations, and list penalties, settlements, or payments under section 353 with drug name, sponsor, and amount. At least 180 days before each report, the Secretary must consult patient groups (including pediatric), consumer groups, industry, academia, and others for suggestions and information.