Sponsors (8)
The bill extends exclusive pricing windows for newly approved drugs (delaying negotiation for up to 11 years) to encourage drug development and preserve access to new therapies, but it does so at the cost of higher drug spending for taxpayers and higher out-of-pocket costs for many patients.
Patients, including Medicare beneficiaries with chronic conditions, may keep access to recently approved therapies without immediate price negotiation for up to 11 years after 2028, preserving current market availability of new treatments.
Drug manufacturers retain longer exclusive pricing windows for newly approved drugs (11 years after 2028), which can increase incentives to invest in drug development and may indirectly benefit hospitals and patients through continued R&D.
Taxpayers and government health programs (including Medicare and Medicaid) will likely pay higher prices for newer drugs for a longer period because fewer recently approved drugs will be subject to negotiated prices until 11 years after approval, increasing public spending.
Patients—particularly those with chronic conditions and Medicare beneficiaries—may face higher out-of-pocket costs for newer therapies for a longer time because negotiated (lower) prices are delayed until 11 years post-approval.
Based on analysis of 2 sections of legislative text.
Introduced March 4, 2025 by Thomas Roland Tillis · Last progress March 4, 2025
Increases the minimum time after FDA approval that a drug or biologic must be on the market before it can be selected for the federal Drug Price Negotiation Program: the 7‑year minimum stays in place for initial price applicability years 2026 and 2027, but for initial price applicability year 2028 and every initial price applicability year after that the minimum becomes at least 11 years. The change delays when newer drugs become eligible for federal price negotiations, which likely reduces the number of drugs subject to negotiation in later years and shifts when potential price reductions would occur.