Promising Pathway Act

S 1906, the Promising Pathway Act, creates a faster FDA approval pathway for new drugs treating serious or life-threatening conditions, allowing provisional approval within 90 days of application. It requires drug sponsors to establish patient registries tracking usage and outcomes (with 90% participation minimum), mandates insurers to cover these drugs identically to fully approved drugs, and sets 2-year provisional approval periods renewable up to three times (max 8 years total). The bill includes safety monitoring, with withdrawal if serious side effects outweigh benefits or if full approval isn’t sought within 180 days. This directly affects drug manufacturers, patients with serious conditions, and health insurers by altering approval timelines, coverage rules, and post-approval monitoring.