Sponsors (6)
The bill would expand access and affordability for many patients by permitting regulated importation of lower-cost, certified foreign drugs, trading off increased regulatory and administrative burdens, tangible safety and supply risks from reliance on foreign systems, and potential long-term effects on domestic drug investment.
Patients with chronic conditions, low-income Americans, and Medicare/Medicaid beneficiaries could gain access to lower-priced prescription drugs through certified foreign importation, reducing out-of-pocket costs and making it more likely they fill needed prescriptions.
People who pay for prescription drugs (including insulin users and seniors) may legally import up to a 90-day personal supply with a valid U.S. prescription, making it easier to obtain medicines when domestic prices are high.
American households and government programs could see lower spending on high-cost patented drugs if regulated importation reduces U.S. prices, producing savings for taxpayers and beneficiaries.
Patients (including seniors and those with chronic conditions) face safety and efficacy risks if non‑FDA‑approved formulations, counterfeit, substandard, or diverted drugs enter U.S. supply because of differences or lapses in foreign oversight, labeling, or chain-of-custody controls.
The FDA and HHS will incur substantial new regulatory responsibilities and administrative costs to certify, inspect, test, and monitor foreign sellers and imports, likely requiring more staff, funding, and program administration (offset by fees or federal resources).
Greater reliance on foreign suppliers could expose U.S. patients and health systems to supply disruptions from geopolitical tensions, trade disputes, or export restrictions, risking shortages at critical times.
Based on analysis of 3 sections of legislative text.
Requires HHS/FDA to create a regulated program (within 1 year) allowing importation of qualifying prescription drugs from specified foreign countries with certification, labeling, and safety rules.
Introduced May 1, 2025 by Janice D. Schakowsky · Last progress May 1, 2025
Requires the Department of Health and Human Services (HHS) and FDA to write regulations, within one year, that allow importation of certain prescription drugs from specified foreign countries by certified foreign sellers, pharmacies, wholesale distributors, and registered U.S. importers. The law defines which drugs qualify, creates certification and fee requirements for foreign sellers, sets labeling and safety expectations, and excludes certain controlled or compounded products.