Bill > HR5416

This bill, titled the "Give Kids a Chance Act," aims to amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities for the Food and Drug Administration (FDA) regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer. The key provisions of the bill include: (1) Expanding the FDA's authority to investigate combinations of active ingredients in cancer drugs, including those with existing investigational use exemptions or approved drugs/biologics, to yield meaningful pediatric study data on dosing, safety, and preliminary efficacy. (2) Applying certain existing provisions related to internal committee review, labeling changes, information dissemination, and adverse events to these expanded investigations. (3) Allowing the FDA to require preclinical studies of adult cancer drugs to assist in determining the relevance of their molecular targets to the growth or progression of pediatric cancers, as a condition of granting investigational use exemptions.