Bill > S1644

This bill, the Promising Pathway Act, establishes a time-limited provisional approval pathway for certain drugs and biological products that are intended to treat or prevent serious diseases or conditions, especially those without available meaningful treatments. The key provisions include: - Requiring the FDA to establish a priority review system to evaluate provisional approval applications within 90 days, or within 3 weeks during epidemics/pandemics. - Allowing the use of real-world evidence and scientifically substantiated surrogates to support provisional approval applications. - Mandating that all patients using a provisionally approved product participate in an observational registry until the product receives full approval, with penalties for low patient participation. - Prohibiting denial of coverage for provisionally approved drugs on the basis of them being experimental, and requiring they be treated the same as fully approved drugs. - Creating the position of Patient Advocate General within the FDA to assist patients and families using drugs evaluated under this pathway or other FDA-approved products. - Limiting provisional approval to a 2-year period, renewable up to 6 years total, and requiring the drug to be brought to market within 180 days or the approval will be rescinded.

Health and Social Services

https://www.congress.gov/bill/117th-congress/senate-bill/1644/all-info