PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Version 00 · Introduced in Senate · Jul 14, 2016
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act
This bill amends the Federal Food, Drug, and Cosmetic Act to expand requirements for assessing the use of medications in pediatric populations.
Applications and supplements to applications for certain drugs and biological products, including orphan drugs, that could be used to treat pediatric cancer must include an assessment of pediatric use. Upon request, the Food and Drug Administration (FDA) must meet with the sponsor of such a medication to discuss the plan for pediatric studies.
Showing the opening paragraphs of the official summary.
The FDA may require the sponsor of an approved medication that could be used to treat pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients.
The bill limits waivers of pediatric assessment requirements for certain medications that could be used to treat a pediatric cancer for which there is a need for additional treatment options.
The FDA must meet with medication sponsors to discuss a deferral or waiver of the pediatric assessment requirement.
People & committees
Sen. Bennet, Michael F. [D-CO] · D–CO
Legislative record
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Dec 5, 2025. Consult Congress.gov for the current record.
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