Affordable and Safe Prescription Drug Importation Act of 2025
Sponsored By: Representative Schakowsky
Introduced
Summary
Creates a federal framework to allow importation of certain prescription drugs. The bill aims to lower U.S. drug costs while protecting safety, quality, and supply-chain integrity through certification, testing, and oversight.
Show full summary
- Patients and families could access qualifying lower-cost drugs imported from Canada, the United Kingdom, the European Union, and Switzerland, with additional countries allowed after one year. Individuals may also import for personal use under program rules and case-by-case guidance.
- Pharmacies and wholesale distributors can participate but must buy from registered facilities and certified foreign sellers, meet import-tracing duties, and provide biannual reports. Foreign sellers face certification and recertification every two years and may be suspended for noncompliance.
- Safety and enforcement tighten supply controls with required English labeling, testing, adverse-event reporting, and recall procedures. The Secretary of Health and Human Services runs a phased rollout and oversight, the bill adds criminal penalties for internet-enabled illegal drug sales (up to 10 years imprisonment or a fine up to $250,000), and HHS and the Government Accountability Office must report on outcomes.
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Bill Overview
Analyzed Economic Effects
5 provisions identified: 4 benefits, 1 costs, 0 mixed.
New path to import lower-cost drugs
The bill would direct HHS to set up national rules within 1 year to let pharmacies, wholesalers, and individuals import certain prescription drugs. At first, only certified sellers in Canada, the United Kingdom, EU countries, and Switzerland could sell to the U.S. Sellers would meet safety and testing rules, use English labels, renew every 2 years, and could be suspended for violations. Drugs must match the U.S. version in ingredient, strength, and how you take it; insulin and some biologics could qualify, but controlled substances, some anesthetics, and compounded drugs would not. Importers would report twice a year on maker IDs and prices paid, and follow any special REMS safety steps if the U.S. version has them. One year after final rules, HHS could add more countries if safety standards are met.
Personal drug imports up to 90 days
You would be able to buy up to a 90-day supply of a qualifying drug for personal use from a certified foreign pharmacy in Canada, the United Kingdom, EU countries, or Switzerland. The pharmacy would need a valid prescription from a U.S.-licensed practitioner, and the medicine could not be for resale.
Ban drugmaker limits on import sellers
The bill would bar drugmakers from charging certified foreign sellers higher prices or cutting off supply because they export to the U.S. It would also prohibit creating different versions just to block export or other actions to delay imports. There would be an exception for drugs on the official shortage list.
Tougher penalties for unsafe online drug sales
Selling counterfeit or adulterated drugs online to people in the U.S., or shipping drugs online without a valid prescription, would become a crime. Violators could face up to 10 years in prison and fines up to $250,000.
In-person doctor visit for import
To use the import path, your prescriber would need to have seen you at least once in person. Telemedicine-only prescriptions would not meet this rule, which could mean extra time or travel for some patients.
Sponsors & CoSponsors
Sponsor
Schakowsky
IL • D
Cosponsors
Cohen
TN • D
Sponsored 5/1/2025
Doggett
TX • D
Sponsored 5/1/2025
Omar
MN • D
Sponsored 5/1/2025
Pingree
ME • D
Sponsored 5/1/2025
Pocan
WI • D
Sponsored 5/1/2025
Roll Call Votes
No roll call votes available for this bill.
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