42 U.S.C. § 284m — Program for pediatric studies of drugs

(a) List of priority issues in pediatric therapeutics. (1) Within a year of September 27, 2007, the Secretary — through the NIH Director, consulting the FDA Commissioner and pediatric research experts — had to publish a priority list of drugs, biological products, or medical uses needing more pediatric study. This list must be updated every three years. (2) In building and prioritizing the list, the Secretary must consider: (A) gaps in pediatric knowledge, like drug metabolism in children and pediatric clinical trials; particular pediatric diseases where better testing could help; and whether enough infrastructure — like research networks and trained investigators — exists; and (B) may also consider whether qualified countermeasures, security countermeasures, and pandemic or epidemic products (each defined elsewhere in this title) are available for children, in consultation with the Assistant Secretary for Preparedness and Response. (b) Pediatric studies and research. The Secretary, through NIH, must fund entities — universities, hospitals, labs, research organizations, or individuals — that can run pediatric clinical trials or other research on the priority-list issues. The Secretary can use contracts, grants, or other funding methods. (c) Process for proposed pediatric study requests and labeling changes. (1) The NIH Director may submit a proposed pediatric study request to the FDA Commissioner for a priority-list drug, made the same way as under specific sections of the Federal Food, Drug, and Cosmetic Act. The Director may do this for a drug where: (A) there's an approved (or approvable) generic or biosimilar application; (B) all patents and exclusivity periods listed for the drug have already ended for at least one form of it; and (C) more study is needed on whether the drug is safe and effective for children. (2) The FDA Commissioner, consulting the NIH Director, may then issue a written request — including a negotiation timeframe — to every holder of an approved application for that drug, asking them to run the pediatric studies. (3) If no one responds to that request within 30 days, the Secretary, through NIH and consulting the FDA, must publish a public request for proposals to get the studies done another way. (4) A drug holder who was given first right of refusal cannot then also respond to that public request for proposals. (5) A contract, grant, or other funding can only be awarded if a proposal is submitted in the form, with the agreements and assurances, the Secretary requires. (6)(A) Once a pediatric study funded under this section is done, a report — including all data — must go to the NIH Director and the FDA Commissioner. (B)(i) That report is treated as public information and, within 90 days, must be posted on NIH's website (protecting research-participant privacy and any proprietary business information) and (ii) given a docket number by the FDA so the public can comment. (C) The FDA Commissioner must act on the report promptly, starting when it's received, following the process below. (7) Within 180 days of a report being submitted, the FDA Commissioner must: (A) review the report and other available data; (B) negotiate with the drug's approved-application holders over any labeling changes the Commissioner thinks are needed; and (C) put a link to the report, and any requested labeling changes, in the public docket, and post a summary on the FDA's website. (8)(A) If a holder doesn't agree to a requested labeling change within that 180-day period, the FDA Commissioner must send the request to the Pediatric Advisory Committee. (B) Within 90 days of that referral, the Committee must review the available safety and effectiveness information and recommend to the Commissioner whether — and what — labeling changes should happen. (9) Within 30 days of getting the Committee's recommendation, the FDA Commissioner must consider it and, if appropriate, ask the drug holders to make the labeling change. (10) If a holder still doesn't agree within 30 days of that request, the FDA Commissioner may treat the drug as "misbranded" under the Federal Food, Drug, and Cosmetic Act. (11) None of this limits the government's separate authority to bring an enforcement action over inadequate pediatric labeling — using the Pediatric Advisory Committee process doesn't block, delay, or replace an enforcement action, and vice versa. (d) Authorization of appropriations. (1) Congress is authorized to appropriate $25,000,000 for each of fiscal years 2026 through 2028 to carry out this section. (2) Any money appropriated stays available until it's spent.