Prescription Drug Price Relief Act of 2025

HR 3546, the Prescription Drug Price Relief Act of 2025, directs the Secretary of Health and Human Services to determine if brand-name drug prices are "excessive" by comparing U.S. prices to median prices in Canada, the UK, Germany, France, and Japan, or by evaluating factors like patient population size, drug value, and R&D costs. If a price is deemed excessive, the bill automatically voids the manufacturer’s government-granted drug exclusivity (like patent protections) and allows any company to produce generic versions using the original drug data. New manufacturers must pay a reasonable royalty (capped at IRS average rates for pharma) and sell the drug at a price below the "excessive" level. The bill also requires drug manufacturers to submit detailed annual pricing reports with penalties for non-compliance and creates a public database tracking all excessive price determinations and licensing activity.