Bill > HR7269

This bill, the Promising Pathway Act, would establish a time-limited provisional approval pathway for certain drugs and biological products that are intended to treat serious or life-threatening diseases, diseases that pose a threat of epidemic or pandemic, or diseases that have a substantial impact on day-to-day functioning. The bill would require the FDA to establish a priority review system to evaluate these applications within 90 days, and allow for rolling review during epidemics and pandemics. The bill sets standards for provisional approval, including substantial evidence of safety and relevant early evidence of efficacy. It would also allow for the use of real-world evidence and scientifically substantiated surrogates to support provisional approval and full approval. The bill includes transparency and patient monitoring requirements, such as mandatory patient registries, and limits provisional approval to a 2-year period renewable up to 6 years. The bill prohibits denial of coverage for provisionally approved drugs on the basis of them being experimental.