Affordable and Safe Prescription Drug Importation Act of 2025
May 1, 2025
May 1, 2025
Summary
Creates a system for pharmacies, wholesalers, and people to safely import lower-cost prescription drugs from Canada and other approved countries.
What problem does this solve?
Prescription drugs in the United States are much more expensive than in other developed countries, making them unaffordable for many people. This bill allows for the importation of safe, lower-priced drugs from approved countries to increase competition and lower costs for Americans.
Who does this affect?
- Patients and consumers
- Pharmaceutical companies
- Pharmacies and wholesale distributors
What does this bill do?
Allows drug importation
Permits wholesale distributors, pharmacies, and individuals to import safe and affordable prescription drugs from Canada, the UK, the EU, and Switzerland.
Creates certified foreign sellers
Establishes a program for the Secretary of Health and Human Services to certify foreign pharmacies and wholesalers that meet safety and licensing standards.
Sets rules for personal importation
Allows individuals to import a 90-day supply of medicine for personal use with a valid prescription from a U.S. doctor.
Prohibits anti-competitive practices
Makes it illegal for drug manufacturers to charge higher prices or limit supplies to foreign sellers who export drugs to the U.S.
Excludes certain drugs
Does not allow the importation of controlled substances like opioids, anesthetics used in surgery, or specially compounded drugs.
Authorizes expansion to other countries
Allows the Secretary to permit importation from other countries after one year if the initial program proves to be safe.
Establishes safety and testing measures
Gives the Secretary authority to suspend importation if a drug or seller is found to be unsafe and allows for random testing of imported drugs.
What is the real world impact?
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Lowers healthcare costs for consumers
The main goal is to give Americans access to the same safe medications sold in other countries at much lower prices, reducing the financial burden on patients and families.
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Raises potential safety concerns
Critics might argue that allowing drugs from other countries, even with safety checks, could introduce risks of counterfeit or unsafe medications into the U.S. supply chain, despite the bill's oversight measures.
When does this start?
The Secretary of Health and Human Services must create rules to put this program in place within one year of the bill becoming law.
Rulemaking deadline
The Secretary must issue final regulations to permit drug importation no later than 1 year after the bill is enacted.
Expansion to other countries
Beginning 1 year after the final rules are in place, the Secretary can authorize importation from additional countries if the program is deemed safe.
HHS progress report
The Secretary must submit the first report to Congress on the drug importation program within 1 year of the final rules being established.
GAO implementation report
The Government Accountability Office must report to Congress on the program's safety and cost-savings within 18 months of the final rules being established.