HR 5416

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.