H.R. 3162 — Affordable and Safe Prescription Drug Importation Act of 2025

This section states congressional findings that (1) U.S. prescription drug prices are 2.78 times higher on average, and 4.22 times higher for patented drugs, than in other OECD countries; (2) tens of millions of Americans have skipped filling prescriptions due to cost; (3) the FDA has Mutual Recognition Agreements for drug manufacturing inspections with the United Kingdom, European Union, and Switzerland; (4) the FDA has noted fewer negative inspection outcomes for EU manufacturers than U.S. ones; (5) 57% of essential medicines' finished dosage form manufacturing sites are overseas; and (6) millions of Americans import drugs for personal use via FDA enforcement discretion despite technical illegality, with occasional seizures. It expresses the sense of Congress that high U.S. drug prices endanger Americans' health and finances, that importation bans have artificially inflated prices despite foreign manufacturing advances and existing safe imports, and that safe global market participation is feasible with HHS and FDA oversight.

This section revises section 804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) to require the Secretary of Health and Human Services, not later than one year after enactment, to promulgate regulations permitting importation of qualifying prescription drugs into the United States by registered U.S. wholesale distributors and dispensers (importers) and by individuals using a valid prescription (i.e., issued after at least one in-person medical evaluation). It defines qualifying prescription drugs as those approved and marketed in Canada, the United Kingdom, an EU member state, Switzerland, or (subject to subsection (e)) another permitted country, with the same active ingredient(s), route of administration, and strength as an FDA-approved drug (or, for importers only, biosimilars or specified products such as insulin, peritoneal dialysis solution, REMS drugs, certain biological products, and intravenously infused drugs); excludes controlled substances, inhaled surgical anesthetics, and compounded drugs. The Secretary must certify eligible licensed foreign pharmacies and foreign wholesale distributors as "certified foreign sellers" if they meet specified criteria (e.g., compliance with home-country laws, quality assurance programs including blind testing, product authenticity testing); publish and maintain a list of such sellers; and require them to pay a registration fee and sell only to U.S. importers or individuals. (Thus, the provision establishes a regulatory framework for personal importation and commercial importation of lower-cost foreign drugs meeting U.S. safety standards.)