New Bill Targets High Drug Costs: Plan Allows Importing Meds from Canada, UK, EU; Rules Due in One Year

The "Affordable and Safe Prescription Drug Importation Act of 2025" proposes a significant shift in how Americans could access prescription medications, aiming to lower costs by allowing their importation from a list of approved countries. If passed, the Secretary of Health and Human Services (HHS) would have one year to establish regulations for wholesale distributors, pharmacies, and individuals to import certain FDA-equivalent drugs from certified sellers in places like Canada, the United Kingdom, European Union member states, and Switzerland.

Unlocking the Global Pharmacy: How It Would Work

This bill seeks to amend Section 804 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which currently offers a very restricted path for drug importation. The new system would allow for the importation of "qualifying prescription drugs." These are defined as medications already approved and sold in Canada, the UK, the EU, Switzerland (or other countries the Secretary later permits) that have the same active ingredients, dosage form, and strength as a drug approved in the U.S. They must also be properly labeled. However, this wouldn't be a free-for-all; the plan excludes controlled substances, inhaled anesthetics, and compounded drugs. For individuals, the bill would allow the importation of a 90-day supply for personal use, provided they have a valid prescription. For context, the bill notes that prescription drugs in the U.S. are often significantly more expensive—2.78 times more on average, and 4.22 times more for patent-protected drugs—than in comparable developed countries.

Who's Minding the Store? The 'Certified Seller' System

A key component is the creation of "Certified Foreign Sellers." These would be licensed foreign pharmacies or wholesale distributors that the HHS Secretary certifies. To get on this list, which would be publicly available on a dedicated website, sellers must pay a fee (intended to cover the program's administrative and enforcement costs), agree to dispense drugs only with a valid U.S. prescription, comply with their home country's laws, participate in quality assurance programs, notify authorities of recalls, and have grievance resolution processes. After one year, the Secretary could also authorize importation from additional countries if the initial program with Canada, the UK, EU, and Switzerland proves safe and if these other countries meet specific safety and regulatory standards. This discretionary power for expansion is something to watch, as the criteria for adding new countries will be crucial.

Safety Nets and Fair Play: Rules of the Road for Imported Drugs

The bill includes several provisions aimed at ensuring safety and fair competition. The Secretary can approve laboratories for random testing of imported drugs. To prevent gaming the system, it would be unlawful for drug manufacturers to discriminate against these certified foreign sellers by charging them higher prices or restricting drug supplies, with an exception for drugs officially on the FDA's shortage list (a list maintained under section 506E of the FFDCA). Importers would need to submit biannual reports to HHS, including details like the manufacturer's unique facility identifier (a code from section 510 of the FFDCA that helps trace drug origins), transaction information (as defined in section 581(26) of the FFDCA for supply chain tracking), and the price paid for the drug. If issues arise, the Secretary can suspend importation of specific drugs or from particular sellers. Furthermore, importers handling drugs that require special safety protocols, known as Risk Evaluation and Mitigation Strategies (REMS) under section 5051 of the FFDCA, must continue to adhere to those plans. The bill also stiffens penalties under Section 303 of the FFDCA for selling adulterated, counterfeit, or unprescribed drugs online, with potential imprisonment up to 10 years or a $250,000 fine. Interestingly, the bill directs the Secretary to focus enforcement on importations posing a "significant threat to public health" and allows for waivers of importation prohibitions for personal use if the drug doesn't present an "unreasonable risk," adding another layer of discretion.

The Bottom Line: Cheaper Meds, But What's the Catch?

For many folks juggling rising costs, the prospect of accessing the same medications at potentially lower Canadian or European prices could be a game-changer. The bill acknowledges that millions of Americans already import drugs for personal use, despite it being technically illegal due to formulation differences from FDA-approved versions. This legislation aims to create a legal, regulated pathway. However, the success of such a program hinges on robust oversight. Ensuring the safety and integrity of drugs coming from multiple foreign sources is a complex logistical and regulatory challenge for the FDA. The bill mandates reports to Congress—from HHS every two years and from the Comptroller General within 18 months—to analyze the program's implementation, safety, cost savings, and tracing processes. These reports will be critical in understanding if the system is working as intended and genuinely making safe, affordable drugs available without compromising public health.