Sponsors (5)
The bill trades stronger price controls, transparency, and tools to expand competition and recoup excess revenues to lower drug costs for patients and public payers against increased legal/administrative complexity and risks of reduced private-sector incentives that could slow innovation or alter product availability.
Patients (including those with chronic conditions) and other drug purchasers would likely pay lower prices for covered brand drugs because the bill allows the Secretary to identify excessive pricing, cap prices via licensing, and require licensees to sell below the excessive-price threshold.
People needing brand drugs would gain earlier access to lower-cost generic or biosimilar alternatives because the bill authorizes waiving exclusivities and establishing open, non‑exclusive licenses to allow more manufacturers to make or import competing products.
Federal, state, and local purchasers (including Medicare and Medicaid) and taxpayers could see reduced drug spending and program costs as increased competition and capped prices lower procurement and reimbursement outlays.
Drug developers and patent holders could face substantially reduced returns from exclusivity, royalties, or forced licensing, which would weaken incentives for costly R&D and could slow development of new drugs.
Manufacturers may respond to price controls and licensing by raising list prices in other channels/markets, limiting product availability in the U.S., or shifting investment away from certain drug programs, risks that could increase costs or reduce access for some patients.
The bill creates significant new administrative, compliance, and litigation burdens for manufacturers and government agencies (price evaluations, licensing, reporting, enforcement), which could raise costs for businesses and taxpayers and slow implementation.
Based on analysis of 8 sections of legislative text.
Permits HHS to identify excessively priced brand drugs, strip exclusivities, issue open licenses with royalties, require detailed manufacturer reporting, and create a public database.
Introduced May 21, 2025 by Ro Khanna · Last progress May 21, 2025
Requires the Department of Health and Human Services to review brand-name drug prices and identify those that are “excessive” using international price comparisons and other factors. For drugs found to be excessive, the Secretary can remove government‑granted exclusivities, authorize open non‑exclusive licenses to allow other manufacturers to make or import the drug, set royalties, and require manufacturers to submit detailed annual pricing, revenue, R&D, and marketing reports to a public database.