Sponsors (4)
The bill speeds temporary importation to reduce drug shortages and increases transparency, but it raises safety risks, could weaken incentives for domestic supply resilience, and may create unfunded FDA costs.
Patients with chronic conditions can get access to therapeutically equivalent drugs faster during shortages via a 60‑day expedited temporary import authorization.
Hospitals and health systems can avoid care disruptions because treating marginal markets as shortages enables expedited reviews and inspections to help restore supply.
Taxpayers and the public gain more transparency because the bill requires annual reporting on the number of drugs authorized for temporary importation.
Patients with chronic conditions could face increased safety risks if imported drugs rely on foreign approvals later found deficient or if inspections are limited, raising the chance of adverse events.
Hospitals and patients may experience weaker long‑term domestic drug supply resilience because temporary importation and expedited pathways could reduce manufacturers' incentives to invest in U.S. production and supply reliability.
Taxpayers could indirectly bear additional costs if expedited reviews or inspections require more FDA resources and the bill does not provide offsetting funding.
Based on analysis of 2 sections of legislative text.
Allows temporary importation and expedited review of certain foreign-approved drugs during shortages and in marginally competitive markets, with up to 3-year authorizations and annual reporting.
Introduced July 17, 2025 by Amy Klobuchar · Last progress July 17, 2025
Creates a temporary importation pathway and an expedited review route for certain prescription drugs when the U.S. faces shortages or when a drug market is "marginally competitive." The Secretary of Health and Human Services would be able to authorize importation of a same-ingredient drug lawfully marketed in specified foreign countries for up to three years, subject to safety determinations and importer/manufacturer attestations. Defines a "marginally competitive market" (fewer than five approved reference/generic products available for at least two months, an originator approved at least 10 years ago, and no active-ingredient patents) and directs the Secretary to treat such markets as creating a shortage for purposes of expedited review, inspections, and temporary importation; requires annual reporting on how many drugs were authorized under the new importation authority.