Affordable and Safe Prescription Drug Importation Act of 2025

Lower Prescription Drug Costs: The bill addresses the finding that prescription drug prices in the U.S. are significantly higher than in comparable OECD nations, which has led many Americans to not fill prescriptions due to cost (Section 2(a)).

Increased Access to Medications: By allowing the importation of qualifying drugs, individuals can obtain medications such as insulin, peritoneal dialysis solution, and certain biological products that are approved and marketed in permitted countries (Section s 3(a)(5)(B)).

Improved Safety Through Oversight: The act establishes a system where the Secretary can certify foreign sellers who must participate in quality assurance programs, including blind testing, to ensure drug reliability (Section 3(a)(4)(B)(v)).

Expansion of Supply Sources: The Secretary has the authority to permit importation from other countries if they meet high standards for drug approval, safety, and manufacturing-process control (Section 3(a)(5)(e)).

Protection Against Price Discrimination: The bill makes it unlawful for manufacturers to charge higher prices to certified foreign sellers than they charge to people within those same countries, preventing artificial price inflation (Section 3(a)(8)(A)(i)).

Restrictions on Specific Substances: Certain drugs, such as controlled substances, anesthetic drugs inhaled during surgery, or compounded drugs, are explicitly excluded from the importation process (Section 3(a)(5)(C)).

Strict Requirements for Individual Importation: Individuals are limited to importing a maximum of a 90-day supply for personal use and must provide a valid prescription from a practitioner licensed in a U.S. State (Section 3(a)(4)(2)).

Risk of Supply Suspension: The Secretary can immediately suspend the importation of specific drugs, sellers, or importers if there is a pattern of noncompliance or if the products are found to be recalled or in violation of the act's requirements (Section 3(a)(11)(1)).

Potential Penalties for Internet Sales: Individuals or entities operating via the internet face significant legal consequences, including up to 10 years in prison or fines up to $250,000, if they sell adulterated, counterfeit, or drugs without a valid prescription (Section 3(b)).