Importation of Prescription Drugs

Summary#

This bill would let certain U.S. pharmacies, wholesale distributors, and individuals import some prescription drugs from approved foreign sellers in Canada, the United Kingdom, EU member states, and Switzerland. The main change is a new legal program for certified foreign sellers and regulated importers, with safety checks, lab testing, reporting, and penalties for bad actors. The stated goal is to make prescription drugs more affordable while keeping them safe.

• Main change: The Secretary of Health and Human Services must set up a regulatory program (within 1 year) to certify foreign pharmacies and distributors and allow importation of specified “qualifying prescription drugs.”
• Who may import: Registered U.S. dispensers and wholesalers (called importers) and individual patients (for personal use, up to a 90-day supply) when drugs come from certified foreign pharmacies.
• Which drugs: Includes many common drugs and some high-cost categories (insulin, certain dialysis solutions, REMS drugs, some biologics, and IV drugs). It excludes controlled substances, inhaled anesthetics used in surgery, and compounded drugs.
• Safety and oversight: Certified foreign sellers must meet country laws and quality checks, submit to random lab testing approved by the Secretary, and the Secretary can suspend sellers or imports for safety problems.
• Manufacturer limits: The bill makes it illegal for a manufacturer to discriminate against certified foreign sellers (for example, by charging them higher prices or denying supply) or to alter a U.S. product to block exports.
• Reporting and review: Importers must file biannual reports with manufacturer IDs, transaction info, and the price paid. HHS must report to Congress beginning 1 year after regulations and then every 2 years. The Government Accountability Office must report 18 months after regulations on safety and cost effects.

What it means for you#

• Patients / Individuals

  • You could order certain prescription drugs from certified foreign pharmacies for personal use (up to 90 days) if you have a valid U.S. prescription and the foreign pharmacy is on the federal list.
  • You must have had at least one in-person medical visit with the prescriber who issued the prescription.
  • Imported drugs must be labeled in English and meet other labeling rules the Secretary sets.

• Pharmacies and U.S. wholesale distributors

  • Registered dispensers and wholesalers may become importers and bring qualifying drugs into the U.S. if they follow the program’s rules and reporting requirements.
  • They will need to keep records, file biannual reports, and follow safety controls similar to domestic requirements.

• Foreign pharmacies and wholesalers

  • To sell to U.S. importers or individuals, they must be certified by HHS, pay an annual fee set to cover program costs, and meet quality and reporting standards.
  • HHS will publish a list of certified foreign sellers with contact information.

• Drug manufacturers

  • Manufacturers are barred from charging certified foreign sellers higher prices (including after rebates) or from denying or restricting supplies to block lawful exports.
  • The bill also prohibits making product differences intended to prevent exports to the U.S.

• Online drug sellers

  • The bill creates a new criminal penalty (up to 10 years in prison and up to $250,000 fine) for websites that knowingly or recklessly sell adulterated or counterfeit drugs to U.S. consumers or dispense drugs without a valid prescription.

• Government agencies

  • HHS/FDA must create and run the certification program, approve testing labs, set fees, conduct enforcement, and produce regular reports. The GAO will review implementation.

Expenses#

The bill may increase administrative costs, but no estimate is available.

• The Secretary must set a certification fee for foreign sellers each year that is “sufficient, and not more than necessary,” to pay program administration and enforcement costs.
• The program will require funding for staff time, oversight, inspections or cooperation agreements with other countries, and approved laboratories for random testing.
• Importers and certified foreign sellers will have compliance costs for recordkeeping, testing, and reporting.
• There is no fiscal note or dollar estimate in the provided material.

Proponents' View#

• The bill appears intended to lower drug prices for U.S. patients by allowing access to medicines sold more cheaply in other countries.
• It aims to use existing regulatory systems in Canada, the U.K., EU states, and Switzerland — and later other countries meeting safety standards — as an alternative supply source.
• The law builds in safety steps: certification, lab testing, labeling rules, and the power to suspend unsafe sellers or products.
• Supporters may argue that requiring fees to cover program costs limits taxpayer burden.

Opponents' View#

• One concern is that the bill leaves several implementation details unclear, such as how HHS will determine when to add other countries and how memoranda of understanding with foreign governments will work.
• It is uncertain how the program will prevent diversion or trans-shipment (re-routing goods to other markets) and how import tracing will work in practice.
• Allowing some biologics and REMS drugs raises technical safety questions because these products can be more complex to handle and monitor than ordinary pills.
• Enforcement and oversight will require staffing, testing, and international cooperation; it is unclear whether the proposed fee mechanism will cover all real costs.
• The prohibition on manufacturer discrimination may be difficult to enforce and could prompt legal disputes about pricing and supply practices.