Trump’s Push to Boost Drug Imports Met With Doubt on Feasibility

President Donald Trump’s push to lower pharmaceutical prices by buying more drugs from abroad likely won’t work and may not even be legal, according to policy analysts and researchers.

Trump issued an executive order Monday pushing drugmakers to bring US prices for pharmaceuticals, the highest in the world, in line with what other countries pay. The order directs the US Food and Drug Administration to explore situations in which the agency could consistently grant waivers “to import prescription drugs on a case-by-case basis from developed nations with low-cost prescription drugs.”

The directive, a continuation of one of the first Trump administration’s policy priorities, appears to go beyond the statutory authority granted to FDA to approve state-run programs to import prescription drugs from Canada, but not other countries. The FDA has so far only approved one state importation program, in Florida, which has yet to import any drugs from Canada.

The FDA’s statutory limitations, as well as the limited evidence that importation will bring widespread savings, make the proposal an unrealistic plan in the minds of drug pricing analysts and researchers. They argue the Trump administration would be better suited to work with Congress to codify policy changes that could better lower what patients pay at the pharmacy counter.

“The fact that the Trump administration continues to come back to the unworkable idea of importing lower-cost versions of expensive brand-name drugs from Canada and other places to address the US prescription drug market shows just how unserious they are at really addressing the issue of unnecessarily high drug prices for US patients,” said Aaron Kesselheim, a professor and researcher at Harvard Medical School.

Statutory Questions

Trump’s executive order contains little detail on how he aims to achieve the policy priorities, including importing prescription drugs from countries beyond Canada.

Section 804 of the federal Food, Drug, and Cosmetic Act allows states to import certain prescription drugs from Canada if the FDA determines it will significantly reduce costs for Americans without imposing additional risks to public health and safety. Florida is the only state with an approved importation program, though several other states have passed laws allowing state officials to pursue FDA approval.

The law is limited to Canadian imports, leaving it unclear how the Trump administration plans to approve purchases from other countries without an act of Congress, said Nicholas Bagley, an administrative and health law professor at the University of Michigan.

“Maybe they’ve got some creative theory they’re going to come up with to allow for broader importation,” but any attempt to bypass Congress will likely draw a legal challenge, Bagley said in an interview.

The order suggests the FDA will “more actively use Section 804 waivers to certify the safety of personal drug importation,” said Nisha Quasba, director of health policy and government relations at Faegre Drinker Biddle & Reath LLP.

Personal importation of prescription drugs is generally prohibited, but Section 804 allows the FDA to grant to individuals, either “by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices.”

The federal agency may publish guidance describing circumstances where it may consistently grant waivers to allow personal importation.

But “no current system exists to approve these waivers—one would need to be established,” Quasba said in an email.

‘Unworkable Plan’

Drug pricing policy analysts and patient advocacy groups have repeatedly questioned the likelihood of drug importation having any widespread effect on US prescription drug prices.

“Drug importation is an unworkable plan for the vast majority of expensive brand-name drugs at the scale that it would need to be undertaken to have a meaningful effect on drug access,” Kesselheim said in an email.

Patients for Affordable Drugs Now expressed similar doubts, noting in a press release Monday that the Trump administration’s proposal “could face logistical, regulatory, and trade challenges—particularly given the supply limitations in countries like Canada.”

Canada has repeatedly voiced opposition to exporting pharmaceutical products to Florida or elsewhere in situations where it would threaten the country’s own supply.

Mallory McManus, deputy chief of staff at Florida’s Agency for Health Care Administration, attributed the importation delays to “significant roadblocks put up by pharmaceutical companies and the Biden Administration.”

“We appreciate the new Administration’s focus on prescription drug prices and look forward to working with them to finally get Florida’s Canadian drug importation program off the ground,” McManus said in an email after Trump’s April executive order calling on the FDA to improve the importation pathway.

Any potential prescription drug savings from importation could also be undermined by the Trump administration’s tariffs on Canada and other countries, as well as tariffs on pharmaceuticals the White House is expected to announce in the near future.

Bagley said the Trump administration should utilize other tools at its disposal to lower prescription drug costs, including testing out alternative payment models at the Center for Medicare and Medicaid Innovation. Trump could also work with Congress to tackle prescription drug prices through legislation building on provisions in the Biden-era Inflation Reduction Act that established drug price negotiations for the most expensive drugs provided in the Medicare program.

“If you think we ought to be paying less for drugs, pass a law,” Bagley said. “Otherwise, why are we outsourcing the question about pharmaceutical pricing to our neighbors?”

“It’s just an abdication of responsibility,” he said.