§355c–1 Report

Summary

The Secretary must prepare and send a report to the Senate Committee on Health, Education, Labor, and Pensions and to the House Committee on Energy and Commerce, and post it on the FDA website, not later than four years after July 9, 2012, and every five years after that. The report must review how well the rules in sections 355a and 355c are working for pediatric drug and biologic use. It must say how many labeling changes have happened since July 9, 2012, how many required pediatric studies missed their initial deadlines (including counts and reasons for deferrals, deferral extensions, waivers, partial waivers, and letters), how pediatric study planning has worked, how many written requests were issued/accepted/declined and any important gaps caused by declined requests, and the status of referrals under section 355a(n). The report must also evaluate studying biologics in children, efforts and results to increase neonatal studies, the number and importance of pediatric cancer drugs being tested and any suggested program changes, ways to improve pediatric drug research and labeling, studying rare-disease drugs, the effect of the 2017 FDA Reauthorization Act amendments (including compliance with deferral deadlines), and efforts to get pediatric studies done earlier (with specific timing measures listed). It must list sponsors who got exclusivity after receiving certain letters before studies were finished, list required assessments and investigations, report how many molecularly targeted cancer drug requests were issued and completed for drugs approved before 3 years after August 18, 2017, evaluate section 504 of the 2017 Act and give recommendations, and list penalties, settlements, or payments under section 353 by drug, sponsor, and amount. At least 180 days before each report is sent, the Secretary must talk with patient groups, consumer groups, industry, academics, and others to get recommendations and information for the report.