The Affordable and Safe Prescription Drug Importation Act of 2025 seeks to address the crisis of high prescription drug prices in the United States by facilitating the importation of more affordable and safe medications. Congress finds that U.S. drug prices are significantly higher than in comparable countries, leading millions of Americans to forgo necessary prescriptions. The bill acknowledges that foreign nations, including Canada, the United Kingdom, European Union members, and Switzerland, have robust drug approval and manufacturing standards, and that the U.S. pharmaceutical supply chain already heavily relies on imported drugs. This legislation amends the Federal Food, Drug, and Cosmetic Act to permit the importation of "qualifying prescription drugs" by wholesale distributors, pharmacies, and individuals. Initially, these drugs can be imported from certified foreign sellers in Canada, the United Kingdom, European Union member states, and Switzerland. Qualifying drugs must have the same active ingredients, route of administration, and strength as U.S.-approved versions, and be labeled in English, excluding controlled substances, anesthetic gases, and compounded drugs. The Secretary of Health and Human Services is tasked with promulgating regulations and certifying foreign sellers, who must meet stringent criteria for safety, quality assurance, and compliance with their home country's laws. Certified foreign sellers must agree to product testing, notify of recalls, and establish grievance resolution processes. Individuals can import a 90-day supply for personal use from certified foreign pharmacies with a valid U.S. prescription. After one year, the Secretary may expand importation to other countries that meet specified safety and regulatory standards. The bill includes strong enforcement mechanisms, making it unlawful for manufacturers to discriminate against certified foreign sellers through pricing or supply restrictions, or to alter drug formulations to prevent importation. It also establishes enhanced penalties, including imprisonment and fines, for individuals or entities operating online websites that fraudulently sell adulterated or counterfeit drugs, or dispense drugs without a valid prescription. The Secretary is authorized to suspend importation if safety concerns arise, and both HHS and the Government Accountability Office (GAO) are required to submit reports on the program's implementation, safety, and cost-savings.
Affordable and Safe Prescription Drug Importation Act of 2024
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
Affordable and Safe Prescription Drug Importation Act of 2025
USA119th CongressHR-3162| House
| Updated: 5/1/2025
The Affordable and Safe Prescription Drug Importation Act of 2025 seeks to address the crisis of high prescription drug prices in the United States by facilitating the importation of more affordable and safe medications. Congress finds that U.S. drug prices are significantly higher than in comparable countries, leading millions of Americans to forgo necessary prescriptions. The bill acknowledges that foreign nations, including Canada, the United Kingdom, European Union members, and Switzerland, have robust drug approval and manufacturing standards, and that the U.S. pharmaceutical supply chain already heavily relies on imported drugs. This legislation amends the Federal Food, Drug, and Cosmetic Act to permit the importation of "qualifying prescription drugs" by wholesale distributors, pharmacies, and individuals. Initially, these drugs can be imported from certified foreign sellers in Canada, the United Kingdom, European Union member states, and Switzerland. Qualifying drugs must have the same active ingredients, route of administration, and strength as U.S.-approved versions, and be labeled in English, excluding controlled substances, anesthetic gases, and compounded drugs. The Secretary of Health and Human Services is tasked with promulgating regulations and certifying foreign sellers, who must meet stringent criteria for safety, quality assurance, and compliance with their home country's laws. Certified foreign sellers must agree to product testing, notify of recalls, and establish grievance resolution processes. Individuals can import a 90-day supply for personal use from certified foreign pharmacies with a valid U.S. prescription. After one year, the Secretary may expand importation to other countries that meet specified safety and regulatory standards. The bill includes strong enforcement mechanisms, making it unlawful for manufacturers to discriminate against certified foreign sellers through pricing or supply restrictions, or to alter drug formulations to prevent importation. It also establishes enhanced penalties, including imprisonment and fines, for individuals or entities operating online websites that fraudulently sell adulterated or counterfeit drugs, or dispense drugs without a valid prescription. The Secretary is authorized to suspend importation if safety concerns arise, and both HHS and the Government Accountability Office (GAO) are required to submit reports on the program's implementation, safety, and cost-savings.