The Trump administration announced proposed rules Wednesday to allow states to establish programs to import drugs from Canada and to give drug companies a path to importing less-expensive international versions of the drugs sold.
The Department of Health and Human Services proposals, first promised in July, consist of two drug importation pathways falling under Food and Drug Administration oversight. The first would permit states to draw up plans for importing drugs from Canada detailing which pharmacies or wholesalers would bring FDA-approved drugs to the United States.
The second proposal would allow drugmakers to use a new drug identification code for medications they sell abroad, allowing them to import versions of the FDA-approved drugs that they sell in foreign countries into the U.S. at lower prices.
HHS Secretary Alex Azar told reporters Tuesday that the administration does not know when they will begin considering states’ proposals but said they are working as quickly as federal regulations will allow.
“We’re moving as quickly as we possibly can under the regulatory process of the Administrative Procedures Act,” Azar said. “I can only assure you that President Trump is fervently committed to bringing down drug prices, fervently committed to the importation of safe drugs from Canada, ending foreign free-riding.”
The plans have been in the works for months, and Trump promised a plan “soon” in November. Azar said the proposals announced Wednesday are “largely very consistent” with an action plan his department put out in July but that this is the “fleshing out of all of the legal and implementation parameters of it.”
HHS will not allow biologic drugs, including insulin, to enter the U.S. from a foreign country. He said, though, that based on the success of the programs early on, Congress could consider later whether to permit some biologics, some of the most expensive drugs, to come to the U.S. from Canada.
