This Act establishes a regulated framework for U.S. wholesale distributors, pharmacies, and individuals to safely import FDA-approved prescription drugs from certified sellers in countries like Canada, the U.K., and the EU to lower consumer costs.
Janice "Jan" Schakowsky
Representative
IL-9
The Affordable and Safe Prescription Drug Importation Act of 2025 aims to lower prescription drug costs for Americans by establishing a regulated system for importing safe, FDA-equivalent medications. This legislation authorizes the Secretary of Health and Human Services to certify foreign sellers in countries like Canada, the U.K., and the EU, allowing wholesale distributors and individuals to legally import qualifying drugs. The bill mandates rigorous safety oversight, including testing and tracing requirements, while also penalizing manufacturers who unfairly restrict supply to certified foreign sellers.
This bill, officially called the Affordable and Safe Prescription Drug Importation Act of 2025, aims to tackle the outrageously high cost of medicine in the U.S. by opening up the border to certain drugs from specific, high-standard countries. The core idea is simple: if a drug is approved and sold safely in Canada, the U.K., the E.U., or Switzerland, and it’s the exact same formula as what’s sold here, Americans should be able to buy it at that lower international price. The Secretary of Health and Human Services (HHS) must create the rules within a year to let U.S. pharmacies, wholesalers, and even individuals import these “qualifying prescription drugs.” Crucially, the bill specifically includes insulin and peritoneal dialysis solutions, which could be a huge win for millions of patients, while strictly excluding controlled substances and surgical anesthetics.
For this to work without flooding the market with fakes, the bill builds a serious safety wall. Only foreign pharmacies or wholesale distributors that get certified by the Secretary—a “Certified Foreign Seller”—can participate. Certification isn’t cheap or easy; sellers must pay a fee, comply with their home country’s laws, and agree to participate in quality assurance programs that include blind testing by U.S. labs. This is smart because it uses the existing regulatory strength of places like the U.K. and E.U. while adding a layer of U.S. oversight. If you’re an individual, you can import up to a 90-day supply for personal use, provided you have a valid U.S. prescription. This provision is key for the busy parent or self-employed person who is currently paying cash for expensive drugs and is one of the clearest paths to immediate savings.
One of the biggest hurdles in past importation efforts has been drug manufacturers refusing to sell to foreign pharmacies that export to the U.S. This bill tries to shut down that tactic. It makes it illegal for a manufacturer to charge a Certified Foreign Seller a higher price than they charge other foreign buyers, or to intentionally deny or delay their supply just because they are exporting to the U.S. This anti-retaliation clause is absolutely critical. Without it, manufacturers could easily starve the foreign sellers of inventory, making the whole importation effort pointless. The bill also prevents manufacturers from subtly changing drug formulas overseas just to make them ineligible for U.S. import, ensuring the price-saving benefit isn’t immediately nullified.
If implemented effectively, this act could significantly reduce the cost of essential maintenance drugs. Imagine the savings for someone with Type 1 diabetes whose insulin costs drop from hundreds of dollars to a fraction of that, simply because they can buy the exact same product from a certified Canadian pharmacy. For businesses, this could lower costs for employee health plans, indirectly benefiting everyone. However, the Secretary has a lot of power here, particularly in defining the “English labeling requirements” and setting up the testing labs. If the rules are too complicated or the certification fees too high, it could slow down the process and limit the number of certified sellers, reducing the competition that drives prices down. The bill also imposes tough new penalties—up to 10 years in prison—for anyone operating an internet site that knowingly sells counterfeit or adulterated drugs to Americans, which is a necessary step to secure the online marketplace.
For those who are skeptical, it’s worth noting the bill allows the Secretary to use “enforcement discretion” for individuals who import drugs for personal use, focusing instead on threats to public health. This formalizes what many Americans already do out of necessity. Furthermore, if the system works safely for a year with the initial four countries, the Secretary gains the authority to expand importation to other nations with similarly strong safety standards. This gradual expansion model suggests a cautious, safety-first approach to opening up the market. While this bill won’t fix the entire drug pricing crisis overnight, it’s a massive step that uses the power of international markets to inject competition into the U.S. system, potentially offering real financial relief to millions of working Americans.