A survey by the Kaiser Family Foundation in 2016 estimated that 8% of Americans or one of their family members had bought prescription drugs from outside the U.S., representing about 19 million people. One peer-reviewed study published in JAMA in 2020 concluded that 2.3 million people in the U.S. with prescriptions buy medications internationally because of cost each year.

In 2024, the late founder of Patients for Affordable Drugs, David Mitchell, called personal importation a “safety valve” for patients when brand-name drugs are not covered by insurance. Allowing wholesale drug importation beyond Canada to the European Union would also lead to substantially lower drug prices at U.S. pharmacies.

Many brand-name drugs sold abroad are the same products sold in the United States, made by the same manufacturers in the same facilities, and priced differently across countries, such as Australia, Canada, the European Union, New Zealand, and the United Kingdom.

Legitimate concerns about the quality of and over-dependence on generic drugs from China must be addressed, but those concerns are distinct from the safety of importing brand-name drugs from peer countries. Additionally, the threat of counterfeit drugs is serious, but should not be conflated with safe wholesale drug importation, or personal drug importation from credentialed foreign pharmacies.

Further, labeling a personally imported drug as “misbranded” or “unapproved” under the FDCA does not mean it is unsafe or poses a risk to patients.

Opponents of drug importation argue that the United States maintains a “gold standard” in drug safety through a tightly regulated “closed” distribution system, and that importation of lower-cost drugs would undermine those protections and increase the risk of counterfeit or substandard medicines.

The U.S. system remains highly advanced, but it is no longer uniquely the “gold standard” in drug safety; in key areas of supply-chain integrity—including importer-side accountability, batch release, and anti-counterfeit controls—the European Union imposes stricter safeguards, while the notion of a wholly “closed” U.S. system is belied by the global reality of pharmaceutical manufacturing and distribution.

Not only does federal law allow the importation of prescription drugs, but because most drugs sold in U.S. pharmacies are foreign-made, importation is the main artery of our drug supply chain.

The debate exists because federal law only allows drug manufacturers to reimport their own drugs, and it restricts commercial-scale importation by independent actors. But those statutory restrictions do not extend to personal use imports, and federal law states that the FDA should exercise enforcement discretion to permit personal importation that does not pose an “unreasonable risk” to consumers.

According to data obtained under the Freedom of Information Act and investigative reporting, out of 53,000 drug products detained at international mail facilities by the FDA in 2022, zero were fentanyl, and 33 were opioid drugs.

Instead, many drugs that the FDA destroys at international mail facilities are for asthma, cancer, diabetes, and HIV.

Under Section 804 and the associated federal rule, states can sponsor programs allowing for wholesale drug importation from Canada. Separately, Section 804(j)(1) authorizes the Secretary to permit personal importation using enforcement discretion, and Section 804(j)(2) gives the Secretary broad authority to issue waivers to import a prescription drug from any country.

Exaggerated or unsupported claims about “potential” risks can distort patient decision-making and harm patients. For decades, Americans have gone online to purchase prescription drugs from Canada and other countries where they can afford them.

Others have walked into pharmacy storefronts to get help filling their prescriptions internationally at much lower prices. These drug savings initiatives should be judged by the value of their assistance to patients.