Importation Is Not a Fix. It Is a Symptom of a System Built to Shift Cost.

On October 22, 2026, U.S. Customs and Border Protection begins enforcing a change that ends the de minimis exemption, which let packages valued at $800 or less enter the country without formal declarations. It traces to Executive Order 14324 in July 2025 and to H.R. 1, which repealed the exemption by statute effective July 1, 2027. Customs fees on mailed drug shipments began in August 2025. CBP published the interim final rule on June 24, 2026, with a compliance date of October 22, and the electronic filing system that replaces the old pass-through began testing in September. Under the new process, mailed drug shipments are screened by customs brokers against the FDA’s import criteria rather than waved through. By one estimate, more than four million people have bought unregulated medications from abroad.

Importing prescription drugs that are approved in the United States was always illegal. The FDA tolerated personal shipments through enforcement discretion described in its Regulatory Procedures Manual, a posture for agency staff rather than a right held by patients, and the agency states plainly that this discretion should not be read as a license to bring in such shipments.

The Safety Risk Is Real

The U.S. operates one of the safest drug supply chains in the world. Under the Drug Supply Chain Security Act, medicine made for American patients carries traceability from the factory floor to the pharmacy counter, a system Congress built after counterfeit medicines with too little active ingredient spread through the country. Imported medicine sits outside that system. There is no nationalized track-and-trace system in Canada or most other countries, and once a drug leaves the regulated chain, no one can verify where it was made, how it was stored, or whether it is what the label claims.

A pharmacy website that advertises itself as “Canadian” is not evidence that any medicine ever touched Canada. The Government Accountability Office (GAO) found that rogue online pharmacies routinely pose as Canadian while operating elsewhere or sourcing drugs from other countries, trading on the trust Americans place in the Canadian system. When GAO purchased drugs from sites presenting themselves this way, the medicines arrived sourced from countries including India, Pakistan, Thailand, and Turkey, often without the dispensing labels or warnings a legitimate pharmacy provides. A reputable-looking storefront taking an order and drop-shipping from a third country is a documented pattern. In one recent case, a patient living with HIV in Maryland received Gilead’s Biktarvy shipped from Turkey, the bottle labeled in Turkish.

The global supply those sites draw on is not safe. The World Health Organization estimates that 1 in 10 medical products in low- and middle-income countries is substandard or falsified, based on 48,000 samples across 88 countries. In October 2024, the DEA warned of foreign-based online pharmacies shipping counterfeit pills made with fentanyl and methamphetamine.

The harm is not theoretical for the communities CANN serves. Counterfeit HIV medications have reached U.S. pharmacies and patients, and a Canadian wholesaler was caught distributing counterfeit cancer medicines to U.S. patients. For a person living with HIV, a few missed or subpotent doses can let the virus rebuild resistance. There is no margin for a counterfeit.

The Real Driver Is Payer Design

People do not look abroad because they have weighed the supply chains and chosen the riskier one. Patients look abroad because payers have engineered their own coverage to move costs onto patients. The affordability crisis is real, and it is manufactured by design decisions at every level of the system.

People do not look abroad because they have weighed the supply chains and chosen the riskier one. Patients look abroad because payers have engineered their own coverage to move costs onto patients.

Private insurers and the pharmacy benefit managers they own lead the pattern. Plans are increasingly replacing flat copays with coinsurance, charging a percentage of a specialty drug’s list price rather than a fixed amount, which can mean hundreds or thousands of dollars a month; even if the insurer never pays that list price due to rebate agreements and price concessions They exclude drugs outright, bury others behind step therapy, and place the medicines patients need most on the highest cost tiers.

Manufacturer copay assistance exists to absorb some of that exposure, and in 2023 it offset $23 billion in patient costs. Its reach is narrower than that figure suggests. Insurer copay accumulator and maximizer programs stop that assistance from counting toward a patient’s deductible or out-of-pocket maximum, so the help shows up at one fill and vanishes from the patient’s annual exposure. While many states have forbidden this practice, enforcement is minimal, often dependent on a patient complaint working its way through an insurance commissioner, and we’ve witnessed efforts to carve out these protections from state law.

Employers have their own tool. Alternative funding programs, as CANN documented in August, let a self-insured employer carve high-cost specialty drugs out of the plan entirely, despite an advertised formulary that does include coverage, and route covered workers to manufacturer charities or public safety-net programs built for people with nowhere else to turn, increasing costs to states. Some of these vendors source the carved-out drug from overseas. The Biktarvy shipped from Turkey came through one such program. The importation did not solve an access problem. It created one. Gilead sued, and in August 2026 the Fourth Circuit affirmed a preliminary injunction barring the defendants from importing its medicines.

Public payers are not exempt. State Medicaid programs lean on utilization management, step therapy and prior authorization, that delays access to a prescribed drug. Medicare has moved in the patient’s favor moderately, and the gains are worth naming: the Inflation Reduction Act capped Part D out-of-pocket spending at $2,000 in 2025, rising to $2,100 in 2026, and the Medicare Prescription Payment Plan lets beneficiaries spread that liability across monthly installments rather than paying it all in January. Those caps help patients. They do not reach the structural harms around them. The smoothing program shifts the timing of payment without reducing what pharmacies are owed, which leaves pharmacies fronting the cost and absorbing the cash-flow gap, a float that independent pharmacies serving high-cost patients can least afford to carry. And none of it stops private intermediaries from redesigning plans around coinsurance, so a cap on paper coexists with cost-sharing that still prices patients out at the counter.

The History, and the Choice in Front of Policymakers

The United States has run this experiment before, and patients paid for it. In 2018, a U.S. court prosecuted and fined an online operation that had marketed itself as a safe Canadian pharmacy for selling counterfeit cancer drugs to American doctors. State importation schemes have repeatedly promised savings and safety and delivered neither. When Florida built its program, it first swore it would test every batch, then told HHS testing would not be necessary, and the state legislature rejected a compensation fund for patients harmed by counterfeits the program might let through. Colorado’s later plan cited retail prices the state does not actually pay to manufacture its savings claim, and challenged the FDA’s own requirement to disclose when a drug is imported and from where. These are not programs that bring the U.S. standard abroad. They are programs that are sold to patients under false promises and ultimately bring foreign risk home.

The closed U.S. supply chain is a patient-safety achievement, and defending it is the right call. The mistake would be to treat the border crackdown as the whole of the policy response. A lawmaker reading the affordability numbers faces a real crisis and a tempting shortcut: tolerate importation and call the access problem solved. However, importation solves nothing. It leaves the payer games intact and adds counterfeit and contaminated medicine to the patient’s list of risks. The work that affordability actually requires is the harder work of forcing payers to cover what they promise, barring coinsurance designs and specialty carve-outs that push patients toward the safety net or dangerous alternatives via import, and closing the accumulator loophole that strips assistance of its value. Ending the HIV Epidemic and HCV Elimination depend on uninterrupted access to medicine that is what it claims to be. Patients need a system that works, not policy by gimmick.