Bill > HR3761

This bill establishes a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products intended to treat or prevent serious or life-threatening diseases or conditions, especially where there are no available meaningful or disease-modifying treatments. The bill requires sponsors to establish substantial evidence of safety and relevant early evidence of positive therapeutic outcomes for drugs seeking provisional approval. It allows the use of real-world evidence and scientifically substantiated surrogates to support provisional approval. The bill also mandates patient participation in observational registries and imposes transparency requirements, including prohibiting the denial of coverage for provisionally approved drugs on the basis of being experimental. Additionally, the bill creates the position of Patient Advocate General within the FDA to assist patients and their families using drugs under this pathway or other approved drugs.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/117th-congress/house-bill/3761/all-info