H.R. 5416 · 117th Congress
Give Kids a Chance Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
ButterfieldSponsor7 cosponsors · 6 D, 1 R
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill authorizes the Food and Drug Administration (FDA) to take various actions regarding pediatric cancer treatments, such as requiring pediatric cancer trials involving a combination of drugs when an applicant seeks market approval for a new drug (or biological product).
What it does: CRS summary · Introduced in House · Sep 29, 2021
Give Kids a Chance Act
This bill authorizes the Food and Drug Administration (FDA) to take various actions regarding pediatric cancer treatments, such as requiring pediatric cancer trials involving a combination of drugs when an applicant seeks market approval for a new drug (or biological product).
For an application for market approval for a new adult cancer treatment drug, if the FDA determines that the drug in question is substantially relevant to the growth or progression of a pediatric cancer, the FDA may require a pediatric cancer investigation into that drug's active ingredient in combination with another active ingredient that has received market approval or an exemption for investigational use. Currently, the FDA may only require a pediatric cancer trial for the drug in the application.
Furthermore, when the FDA receives an application for an investigational use exemption for an adult cancer treatment drug, the FDA may require the applicant to conduct up to two preclinical studies to determine the relevance of the drug to pediatric cancer.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Give Kids a Chance Act
Latest action (Sep 30, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Sep 29, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.