Affordable and Safe Prescription Drug Importation Act of 2025
- Sponsor
- Rep. Schakowsky, Janice D. [D-IL-9]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- May 1, 2025
Bottom line
The bill aims to lower prescription drug costs for Americans by creating a regulated pathway for importing safe and affordable drugs from specified foreign countries with robust regulatory standards.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act to establish a federal program permitting the importation of qualifying prescription drugs by wholesale distributors, pharmacies, and individuals from certified foreign sellers in Canada, the United Kingdom, European Union member states, and Switzerland. It mandates the Secretary of HHS to promulgate regulations, defines eligible drugs and participants, sets up a certification and oversight process for foreign sellers, and includes provisions to prevent anti-competitive practices by drug manufacturers.
Proponents argue
Proponents argue that the bill directly addresses the crisis of prohibitively high prescription drug prices in the United States by allowing access to the global pharmaceutical marketplace, where drugs are significantly cheaper. They emphasize the robust safety mechanisms, such as FDA certification of foreign sellers, ongoing drug testing, and reliance on countries with strong regulatory frameworks, as ensuring that imported drugs are safe and effective.
Opponents contend
Opponents, primarily pharmaceutical manufacturers, would contend that allowing broad drug importation could compromise the safety and integrity of the U.S. drug supply chain, despite the bill's safeguards. They might also argue that such a policy undermines intellectual property rights, disincentivizes pharmaceutical innovation, and could lead to an influx of counterfeit or substandard medications.
The bill is moderately detailed, requiring careful reading to understand the regulatory framework, but is generally accessible for an informed reader.
Section 2(a)
Congressional Findings on Drug Prices and Importation Safety
This section outlines Congress's findings that U.S. prescription drug prices are significantly higher than in comparable countries, leading millions of Americans to forgo necessary medications. It also notes the FDA's existing mutual recognition agreements with foreign regulators and the reliance of the U.S. supply chain on foreign manufacturing, asserting that safe importation is feasible.
Supporters argue
Supporters argue these findings provide a strong evidence-based justification for the bill, demonstrating the urgent need for action on drug prices and the feasibility of safe importation given existing regulatory frameworks and international agreements.
Critics contend
Opponents might dispute the interpretation of safety findings, arguing that while some foreign manufacturing is safe, a broad importation scheme introduces new, unmanageable risks to the supply chain.
Tradeoffs
This provision balances the economic imperative of lowering drug costs with the perceived need to maintain strict control over the drug supply chain.
Section 3(a), amending Section 804(a)
Establishment of Drug Importation Program
This provision directs the Secretary of Health and Human Services (HHS) to promulgate regulations within one year of enactment, permitting the importation of "qualifying prescription drugs" into the United States. This establishes the fundamental legal basis and mandate for the entire drug importation program.
Section 3(a), amending Section 804(b)
Definitions for Importation Program
This section defines key terms for the importation program. It specifies 'certified foreign seller' as a licensed foreign pharmacy or wholesale distributor certified by the Secretary, and 'importer' as a U.S. dispenser or wholesale distributor. 'Licensed foreign pharmacy' is limited to those in Canada, the UK, EU, Switzerland, or other permitted countries. 'Qualifying prescription drug' is defined as a drug approved and marketed in these countries, with the same active ingredient and strength as an FDA-approved drug, labeled in English, and excludes controlled substances, anesthetic gases, and compounded drugs. For importers, it specifically includes peritoneal dialysis solution, insulin, REMS drugs, certain biologics, and intravenously infused drugs.
Section 3(a), amending Section 804(c) and (d)
Certification of Foreign Sellers and Rules for Individual Importation
This provision requires the Secretary to publish an online list of certified foreign sellers. To be certified, sellers must be licensed in their country (Canada, UK, EU, Switzerland), comply with local laws, participate in quality assurance, agree to product testing, notify of recalls, and pay a certification fee. Individuals are permitted to import a 90-day supply of a qualifying prescription drug for personal use from a certified foreign pharmacy, provided they have a valid U.S. prescription.
Section 3(a), amending Section 804(e)
Expansion of Permitted Importation Countries
This provision allows the Secretary, one year after the initial regulations are finalized and if importation from the initial countries (Canada, UK, EU, Switzerland) is deemed safe, to permit importation from additional countries. These new countries must meet stringent standards for drug approval, safety, effectiveness, manufacturing quality, adverse reaction reporting, and recall procedures, ensuring comparable regulatory oversight.
Section 3(a), amending Section 804(h)
Prohibition on Manufacturer Anti-Competitive Practices
This provision makes it unlawful for drug manufacturers to engage in various anti-competitive practices. Specifically, it prohibits manufacturers from charging higher prices to certified foreign sellers who import drugs into the U.S., denying or restricting supplies to such sellers, or intentionally altering drug formulations between the U.S. and permitted foreign markets for the purpose of avoiding importation. This aims to prevent manufacturers from undermining the importation program's effectiveness.
Section 3(a), amending Section 804(i)
Formalizing Individual Importation Discretion and Waiver Authority
This provision formally declares that the Secretary should focus enforcement against individuals importing prescription drugs on cases posing a significant public health threat. It directs the Secretary to exercise discretion to permit personal use importation if it doesn't present an unreasonable risk. Furthermore, it grants the Secretary explicit waiver authority for individuals and requires guidance on when case-by-case waivers will be consistently granted, providing greater clarity and certainty for consumers.
Section 3(b), amending Section 303(h)
Enhanced Penalties for Fraudulent Online Drug Sales
This provision establishes new criminal penalties, including imprisonment for up to 10 years or a fine of up to $250,000, for persons operating internet websites who, with intent to defraud or mislead or with reckless disregard for public safety, sell adulterated or counterfeit drugs to U.S. individuals, or dispense drugs without a valid prescription. This targets illicit online drug sales.
Expands the definition of 'qualifying prescription drug' specifically for *importers* (wholesale distributors and dispensers) to include critical and often expensive categories like peritoneal dialysis solution, insulin, drugs requiring a Risk Evaluation and Mitigation Strategy (REMS), biological products (specifically proteins or analogous products), and intravenously infused drugs.
Section 3(a), amending Section 804(b)(5)(B)
Why it matters:While technically correct for defining scope, the specific inclusion of biologics and REMS drugs is highly consequential for patient access and regulatory oversight. Its placement makes it easy for a casual reader to overlook, as they might focus on the general allowance for 'prescription drugs.'
Case for: Proponents would argue this is a critical expansion to address the high costs of some of the most expensive and life-sustaining drugs, ensuring that the importation program delivers maximum relief to patients in dire need of these medications.
Case against: Opponents, particularly pharmaceutical manufacturers, would argue that importing biologics and REMS drugs is significantly more complex and risky due to their sensitive nature, specific safety protocols, and potential for immunogenicity, potentially undermining patient safety and the integrity of these critical therapies.
Estimated impact: Potentially significant cost savings for patients requiring these high-cost medications, but also introduces greater complexity and regulatory burden for oversight due to the nature of these drugs.
Prohibits drug manufacturers from intentionally causing a difference in active ingredient, route of administration, bioequivalence, strength, formulation, manufacturing establishment, manufacturing process, or the person manufacturing the drug between a product for distribution in the United States and one for distribution in a permitted foreign country, specifically for the purpose of avoiding sales by certified foreign sellers.
Section 3(a), amending Section 804(h)(3)
Why it matters:This is a sophisticated anti-circumvention measure, designed to close a potential loophole that manufacturers might exploit to make their foreign products technically ineligible for importation. Its technical nature makes it less immediately obvious than direct price discrimination.
Case for: Proponents would argue this is essential to prevent manufacturers from using technicalities and subtle product differentiation to undermine the bill's intent, ensuring that the promise of affordable drugs through importation is not thwarted by corporate maneuvers.
Case against: Manufacturers might argue this provision unduly restricts their ability to manage product lines and formulations for different markets based on local regulatory requirements, commercial strategies, or legitimate manufacturing efficiencies, potentially infringing on intellectual property or operational flexibility.
Estimated impact: Prevents a significant potential avenue for manufacturers to block importation, thereby preserving the bill's intended cost-saving impact and ensuring the availability of eligible drugs.