Lawmakers urge Trump to rethink new rule that could restrict imported meds from Canada and overseas

STAT News – Tuesday, September 29, 2026
By Ed Silverman

A growing number of congressional lawmakers are urging the Trump administration to rethink a federal rule going into effect next month over concerns it will prevent Americans from obtaining prescription medicines from licensed international pharmacies.

The pending rule requires medicines mailed from abroad to go through a customs process that mandates a licensed customs broker and a financial guarantee in the form of an entry bond. This is an added burden — and cost — for Americans who, for years, have been able to receive prescriptions from Canada and other countries with relatively little difficulty as they sought to save money on expensive drugs.

Indeed, the clamor for imports began two decades ago as prices rose, prompting some Americans to take bus rides to Canada. Under current law, though, it is illegal to import a medicine into the U.S. for personal use under most circumstances because the drugs often have not been approved by the Food and Drug Administration as safe and effective.

Nonetheless, the agency does make exceptions, such as for medicines not used to treat a serious condition and that pose no significant health risk. For serious conditions, personal shipments are allowed so long as the medicine does not represent an unusual safety risk. Generally, no more than a 90-day supply is permitted.

This has created a legal gray area for importation. As a result, U.S. Customs and Border Protection agents have generally allowed low-value, personal-use packages to proceed, and millions of Americans have taken advantage of the situation. A 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.

Now, though, the spigot may be turned off. The Trump administration ordered an indefinite suspension of an administrative exemption for allowing imported packages valued at $800 or less to clear customs, starting Oct. 22. The focus is on unlawful importation of goods, particularly illegal opioids.

However, three House Republicans worry the rule “will inadvertently impact our constituents and millions of other Americans’ access to safe, affordable medications sourced through Canadian and International pharmacies,” according to a Sept. 24 letter written to four different federal agencies, including the Department of Homeland Security and the Health and Human Services Department.

The lawmakers — Scott Franklin, Aaron Bean, and Gus Bilirakis — represent different districts in Florida, one of two states to have received authorization from the FDA to pursue a federal pathway to importing medicines from Canada. The other state is Colorado.

“We believe the intent of the rule is intended to target illegal shipments of fentanyl, opioids, and illicit drugs. We wholeheartedly support that effort, but CBP and FDA must ensure that Floridians simply seeking relief from high drug prices will not be inadvertently impacted,” they wrote.

Meanwhile, a pair of House Democrats — Mark Pocan of Wisconsin and Jan Schakowsky of Illinois — are readying a similar letter to send the administration later this week in which they argue access to affordable medicines should not be sacrificed. So far, they have close to 50 signatures, according to a spokesman for Schakowsky.

Consumer advocates share their concerns. As they see it, the rule change is not consistent with existing federal law and could have serious health consequences for countless Americans who rely on imported medicines at a time when the cost of most prescription drugs continues to rise.

“For many Americans, personal importation is their only affordable option,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group. He maintained that the administration may use the new rule as an excuse to crack down on importation, an issue that has long riled the pharmaceutical industry.

“Federal law gives FDA broad discretion to permit personal importation of prescription drugs that do not appear to present an unreasonable risk,” he added. “That discretion, for example, should protect patients receiving prescribed medications by mail from licensed Canadian pharmacies.”

Although many Americans import prescription medicine from licensed pharmacies in Canada, formally expanding the practice has been controversial and drawn out.

Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian government and its domestic pharmaceutical industry amid fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.

Access this article at its original source.