Sponsors (6)
Introduced May 1, 2025 by Janice D. Schakowsky · Last progress May 1, 2025
The bill expands access to lower-cost imported prescription drugs (benefiting low- and middle-income patients and those with high-cost therapies) while creating measurable safety, oversight, administrative, and long-term innovation trade-offs that policymakers must manage.
Low- and middle-income patients (including people with chronic conditions) can obtain lower-cost prescription drugs by importing approved equivalents from trusted foreign regulators, reducing out-of-pocket spending.
Patients with high-cost needs — e.g., insulin users, people needing peritoneal dialysis solution, certain biologics, REMS drugs, and IV drugs — and Medicare beneficiaries may gain improved access and adherence because authorized importation and a permitted 90-day personal supply lower price barriers.
Patients and health systems benefit from built-in safety measures (certification, quality-assurance testing, English labeling, reporting, and suspension authority) designed to protect drug quality and public health.
Patients and health systems face safety and efficacy risks because imported products may not be FDA-identical and expanded import channels could increase the risk of counterfeit, diverted, or misbranded products entering the U.S. supply chain.
Taxpayers, manufacturers, and industry will likely bear increased regulatory, enforcement, testing, and program-administration costs required to implement and oversee importation.
Domestic pharmaceutical R&D and manufacturing incentives could be reduced if lower U.S. prices from importation persist, potentially harming long-term drug innovation and related jobs.
Based on analysis of 3 sections of legislative text.
Requires HHS to issue rules within one year to allow certified foreign pharmacies/wholesalers and U.S. importers and individuals to import specified safe prescription drugs from listed countries under oversight.
Requires the Department of Health and Human Services to write rules within one year that let certified foreign pharmacies and wholesale distributors, U.S. pharmacies/wholesalers, and individuals import certain prescription drugs from specified foreign countries. The bill defines which drugs may be imported, which are barred, and creates a certification and oversight regime intended to make lower‑cost, foreign‑sourced prescription drugs available to Americans while imposing safety and labeling requirements.