21 U.S.C. § 355c–1 — Report

(a) In general Starting four years after July 9, 2012, and then every five years after that, the Secretary must write a report and send it to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The Secretary must also make the report public, including by posting it on the FDA's website. The report covers how the pediatric drug programs in sections 355a and 355c are working. (b) Contents Each report must include: (1) Whether the programs are working — including how many drug and biological product labeling changes have happened since July 9, 2012, and how important those pediatric uses have been for children's health. (2) How many studies required under section 355c missed their first deadline, including: (A) how many deferrals and deferral extensions were granted, and why; (B) how many waivers and partial waivers were granted; and (C) how many letters were sent under subsection (d) of section 355c. (3) Whether pediatric study planning has been timely and effective since July 9, 2012, including how many initial pediatric study plans were not submitted as subsection (e) of section 355c requires, and any rulemaking that resulted. (4) How many written requests for studies the Secretary issued, accepted, and turned down under section 355a since July 9, 2012, plus a list of important gaps in pediatric information caused by the turned-down requests. (5) A description and current status of referrals made under subsection (n) of section 355a. (6) Whether studying biological products in children under sections 355a and 355c, and under 42 U.S.C. § 284m, has been effective. (7) (A) What the Secretary has done to increase the number of studies done in newborns, including encouraging companies whose products are safe and understood enough to run appropriate studies ethically; and (B) what those efforts achieved. (8) (A) How many, and how important, drugs and biological products for children with cancer are being tested because of the programs under sections 355a and 355c and under 42 U.S.C. § 284m; and (B) any recommended changes to those programs that would lead to new and better cancer therapies for children, with a detailed reason for each recommendation. (9) Any recommended changes to the programs that would improve pediatric drug research and increase pediatric labeling of drugs and biological products. (10) An assessment of what has succeeded and what has fallen short in studying rare-disease drugs under sections 355a and 355c. (11) The impact of the changes the FDA Reauthorization Act of 2017 made to section 355c on pediatric research and labeling, including for molecularly targeted cancer drugs and biological products, and whether deadlines in deferrals and deferral extensions have been met. (12) An assessment of how well the Secretary has carried out the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act for getting pediatric studies submitted earlier under sections 355a and 355c and 42 U.S.C. § 262(m), including: (A) the average time between approval of an application under section 355(b)(1) or 42 U.S.C. § 262(a) and when related pediatric studies are completed, submitted, and added to labeling; (B) the average time before the Secretary responds to a proposed pediatric study request; (C) the average time after a proposed pediatric study request before the Secretary issues a written request for the studies; (D) how many written requests were issued for an investigational drug or biological product before an application under section 355(b)(1) or 42 U.S.C. § 262(a) was submitted; and (E) the average number and range of amendments to written requests, and how long the Secretary takes to review and act on proposed amendments. (13) A list of applicants or approved-application holders who received exclusivity under section 355a or 42 U.S.C. § 262(m) after getting a letter under section 355c(d)(1) — meaning the required studies were not finished on time — for a drug, before those studies were completed and submitted. (14) A list of assessments and investigations required under section 355c. (15) How many requests under section 355a for molecular targeted cancer drugs (as defined in section 355c(a)(1)(B)) approved before three years after August 18, 2017, have been issued by the FDA, and how many have been completed. (16) The Secretary's assessment of the overall impact of the changes made by section 504 of the FDA Reauthorization Act of 2017 on pediatric cancer research and the orphan drug program, plus any further recommendations. (17) A list of penalties, settlements, or payments under section 353 for failing to comply with section 355c, including, for each one, the drug's name, its sponsor, and the amount imposed. (c) Stakeholder comment At least 180 days before submitting each report, the Secretary must consult with representatives of patient groups (including pediatric patient groups), consumer groups, regulated industry, academia, and other interested parties, to get their recommendations and information relevant to the report — including suggestions for modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products.