Sponsors (4)
The bill speeds access to foreign, lawfully marketed drugs to reduce shortages for patients and hospitals, but increases safety oversight risks, federal administrative costs, and could weaken long-term U.S. supply incentives for manufacturers.
Patients with chronic conditions can access alternative, lawfully marketed foreign versions of drugs for up to 3 years during shortages, reducing treatment disruptions.
Hospitals and health systems can obtain imported supplies more quickly because the bill requires a 60-day authorization deadline and expedited handling for marginally competitive markets, easing operational supply pressures.
The bill defines and targets 'marginally competitive drug markets' to trigger faster regulatory action and importation, which could increase supply for older off-patent drugs that often face shortages.
Patients could face safety risks because imported drugs may be approved under different foreign standards, and imports will proceed automatically if the Secretary does not deny them within 60 days.
Manufacturers may respond to authorized imports by shifting costs or reducing incentives to supply the U.S. market, risking long-term domestic drug availability and competition.
Taxpayers and the federal budget could incur increased costs from expedited FDA reviews, inspections, and additional administrative workload required to implement and monitor importation.
Based on analysis of 2 sections of legislative text.
Allows HHS to temporarily authorize importation of certain drugs for up to three years during shortages or in defined marginal markets, with safety checks and reporting.
Introduced July 17, 2025 by Amy Klobuchar · Last progress July 17, 2025
Creates a temporary authority for the Secretary of Health and Human Services to allow importation of certain prescription drugs for up to three years when there is (or is likely to be) a drug shortage or when a market meets defined "marginally competitive" criteria. The authority requires safety and marketing certifications, a 60-day timeline for authorization decisions after receipt of required importer information, and ends when the shortage ends or after three years. The law also defines objective criteria for identifying "marginally competitive drug markets," permits expedited review and inspections for such markets, and adds a reporting requirement on the number of drugs authorized for temporary importation.