WASHINGTON — The Trump administration announced a formal but preliminary plan Wednesday to allow Americans to import certain lower-cost drugs from Canada.
The plan puts most of the onus on state governments, which would have to come up with a proposal for safe importation and submit it for federal approval. Wholesalers and pharmacies could also submit plans.
It’s the latest example of the Trump administration pursuing populist ideas for lowering prescription drugs — ideas that have traditionally been unpopular with drug makers and a large swath of the Republican Party.
“For the first time in HHS’ history, we are open to importation,” health secretary Alex Azar told reporters.
Actual importation of drugs, however, is likely a long way away. After the idea goes through regulatory review — which itself could take months, if not years — the Trump administration plan will only be a pilot, and there’s little clarity on whether it’ll ever be scaled up nationally.
The pilots would also be time-limited, and HHS would have sweeping authority to terminate a program if the agency determined it was unsafe.
Only certain drugs could be imported under those state-based plans. Insulin, in particular, which has become a symbol of the striking price differences between the U.S. and Canada, couldn’t be imported under these programs. On a press call Wednesday, Azar emphasized that insulin, which is a biologic, can’t be imported under existing law.
Nevertheless, a number of states have already expressed interest in doing just what Trump is proposing: Trump has vocally supported a plan from Florida Gov. Ron DeSantis and has publicly directed Azar to find a way to make Florida’s plan work. Colorado and Vermont have also both passed similar laws supporting importation of prescription drugs.
Azar has already discussed the plan with the Canadian health minister, Ginette Petitpas Taylor, he told reporters. Canadian health groups have recently started to lobby the Canadian government to oppose American plans to import drugs, out of a concern that importation could deplete the Canadian drug supply.
“Obviously my interest is to protect American patients and deliver savings for American patients. She has [the] interest of the Canadian system at heart,” Azar said.
Azar also said it would be states’ responsibility, or that of wholesalers who would import the drugs, to ensure the program works.
Congress gave HHS the power to approve programs to import drugs in 2003, but the secretary has never greenlighted any proposals.
“HHS and the Food and Drug Administration have consistently said there were simply no circumstances where importation could be done safely, effectively, and at lower costs to American consumers — just, the door was closed,” Azar said. “What we are saying today is, we are open. There is a pathway. We can be convinced.”
Azar himself has also previously called importation a “gimmick” but has insisted that technological advances have made importation much safer. He also acknowledged Wednesday that Trump had pushed him to rethink his assumptions about the idea.
“He is always pushing me, challenging me, to find more solutions to help the American patient,” Azar said, referring to Trump.
Under the plan released Wednesday, the Food and Drug Administration will also issue advice to drug manufacturers on how they can import their own drugs made in foreign facilities. Should drug makers pursue that path, they could potentially import any drug — including insulin — from any factory around the world.
It’s unclear, however, how many drug makers will be willing to pursue that path. Azar told reporters there has been significant interest from drug makers in doing what HHS is proposing. He added that questions about incentivizing such behavior will be considered in forthcoming guidance from the FDA.
The plan is likely to be staunchly opposed by the pharmaceutical industry, which has insisted importation of drugs is unnecessarily dangerous. Azar told reporters Wednesday he had telegraphed his plans to drug makers, and declined to comment further on their concerns.
“We haven’t spoken about this plan with the pharmaceutical industry,” Azar said. “I’ll let them speak for themselves.”