Americans who can't afford their prescriptions would gain a new legal pathway under this bill: importing the same drugs they already take from licensed pharmacies and distributors in Canada, the United Kingdom, Switzerland, or European Union member countries. Individuals could order up to a 90-day supply for personal use as long as they have a valid prescription from a U.S.-licensed doctor. Pharmacies and wholesale distributors in the U.S. would also be permitted to import drugs abroad and sell them domestically, provided the imported versions contain the same active ingredients, strength, and route of administration as FDA-approved drugs. The FDA (the federal agency that ensures drug safety) would be required to create a certification program within one year, vetting foreign sellers through quality assurance testing, recall notifications, and ongoing compliance checks. Congress pointed to findings that prescription drug prices in the U.S. average nearly three times those in comparable countries, leaving tens of millions of Americans unable to fill prescriptions they've been given. Drug manufacturers would be barred from charging certified foreign sellers inflated prices or cutting off their supply in order to block importation — practices that have historically prevented Americans from benefiting from lower prices abroad.
Congressional Summary
Affordable and Safe Prescription Drug Importation Act of 2025This bill expands the categories of prescription drugs that may be imported into the United States and the countries from which such drugs may be imported.Current law allows the Department of Health and Human Services (HHS) to authorize importation of certain eligible prescription drugs from Canada if HHS certifies that doing so would pose no additional risk to public health and safety, among other requirements. HHS long declined to make the requisite certification, citing safety concerns (e.g., contamination, counterfeiting), but ultimately made the certification in 2020 and has since approved one state plan to import drugs.The bill removes the certification requirement and requires HHS to issue regulations that permit importation of qualifying prescription drugs from the United Kingdom, Switzerland, and member states of the European Union, in addition to Canada. After one year, if HHS determines that importation of drugs from these countries has been conducted safely, HHS may authorize importation from other countries that meet certain requirements.The bill also expands the types of prescription drugs eligible for importation to include, for example, biologics such as insulin.Further, the bill allows individuals to use an eligible licensed foreign pharmacy to fill a U.S.-issued prescription for a qualifying drug for personal use. Currently, an individual seeking to import a prescription drug generally must acquire a waiver from HHS.Finally, the bill imposes criminal penalties for websites that sell counterfeit drugs or dispense drugs without a required prescription.
Details
- Congress
- 119th
- Chamber
- House
- Status
- summarized
- Action
- Introduced in House
- Action Date
- 2025-05-01
- Date Added
- 2026-04-06