Bill > S932

This bill aims to improve research and development of drugs for pediatric cancer by amending the Federal Food, Drug, and Cosmetic Act. The bill introduces new requirements for pharmaceutical companies when developing drugs that could potentially treat pediatric cancers. Specifically, it expands the definition of what constitutes a valid pediatric cancer investigation, allowing companies to conduct studies on drugs that are part of standard cancer care or that target specific molecular mechanisms relevant to pediatric cancers. The bill mandates that these investigations must be designed to yield meaningful clinical data about dosing, safety, and preliminary efficacy for different pediatric age groups. Additionally, the bill extends the authority to issue priority review vouchers for rare pediatric disease treatments until September 30, 2029, which provides financial incentives for pharmaceutical companies to develop drugs for rare childhood diseases. The legislation also requires comprehensive studies and reports to Congress and the Government Accountability Office (GAO) to assess the effectiveness of these provisions in stimulating pediatric cancer drug development, including examining how priority review vouchers impact drug development and patient access to treatments.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/932/all-info