Sponsors (7)
The bill expands access to lower‑cost imported prescription drugs and includes safety and oversight measures that could improve adherence and reduce out‑of‑pocket costs, but it raises safety, administrative, oversight, and long‑term innovation risks that may shift costs or burdens to governments, supply‑chain actors, and potentially patients.
Low- and middle-income patients (and others who struggle with drug costs) could pay significantly less for many prescription drugs because the bill authorizes importing lower-priced, regulatorily-approved equivalents from Canada, the UK, EU states, Switzerland and other approved countries.
Patients who previously skipped or rationed medications because of cost are more likely to fill and adhere to treatments, improving health outcomes for people with chronic conditions.
People who need essential or complex products (insulin, peritoneal dialysis solution, certain biologics, REMS drugs, IV drugs) gain expanded access through authorized importers and personal importation (up to a 90‑day supply with a valid U.S. prescription).
Patients (and health systems) face increased safety risks because imported products may not be FDA‑identical formulations and, if not tightly enforced, counterfeit, diverted, or misbranded products could enter the U.S. supply chain.
U.S. drugmakers could face reduced incentives to invest in domestic R&D and manufacturing if price pressure increases, potentially harming long‑term drug innovation and high‑skill jobs.
Implementing, enforcing, and overseeing the importation program will raise government and enforcement costs that could fall on taxpayers or be recovered through industry fees.
Based on analysis of 3 sections of legislative text.
Requires HHS to issue rules within one year to allow certified foreign pharmacies and distributors to import qualifying prescription drugs into the U.S. under federal safety and labeling requirements.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals.
Introduced May 1, 2025 by Janice D. Schakowsky · Last progress May 1, 2025
Requires the Department of Health and Human Services to write rules within one year to allow importation of certain FDA-approved prescription drugs from specified foreign countries by licensed foreign pharmacies, wholesale distributors, pharmacies, and individuals. Establishes definitions, a certification and listing process for foreign sellers, and eligibility limits for which products may be imported while excluding some controlled and specialized drug categories. Changes current importation law from discretionary to mandatory rulemaking, narrows and defines the scope of allowable imports (including some biologics, insulin, peritoneal dialysis solution, and REMS drugs for importers), and sets safety and labeling conditions and certification fees for foreign sellers under HHS/FDA oversight.