S.3239 - RACE for Children Act114th Congress (2015-2016)
|Sponsor:||Sen. Bennet, Michael F. [D-CO] (Introduced 07/14/2016)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 07/14/2016 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Summary: S.3239 — 114th Congress (2015-2016)All Information (Except Text)
Introduced in Senate (07/14/2016)
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.
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.