The Trump administration wants to “lay the foundation” to begin importing some pharmaceutical drugs from Canada, part of a new law pushed by Gov. Ron DeSantis and approved by the Florida Legislature earlier this year.
It’s not clear, however, how the proposal would clear the considerable hurdles in its path, including opposition by the pharmaceutical industry and reported reluctance by health officials in Canada. Moreover, the rulemaking process could take years to complete and could attract legal challenges.
In trumpeting the development on his Twitter feed, President Trump gave shout-outs to his political protégé DeSantis and Colorado Gov. Jared Polis, whose state also is looking at a Canadian drug import program.
DeSantis tweeted back: “Thank you President @realDonaldTrump for supporting my efforts to lower prescription drug costs for Floridians. You are helping Florida lead the way to make safe and affordable prescription drugs a reality.”
The move marks an about-face by Health and Human Services Secretary Alex Azar, who in May 2018 dismissed such talk as a “gimmick,” noting, “It has been assessed multiple times by the Congressional Budget Office, and CBO has said it would have no meaningful effect.”
Nevertheless, on Wednesday Azar’s agency proposed writing regulations that would allow demonstration projects by states, wholesalers, and pharmacists involving importation of drugs approved for sale in Canada, as long as they contain active pharmaceutical ingredients manufactured at facilities that also produce drugs approved by the U.S. Food and Drug Administration.
At the same time, the agency would look into allowing U.S. manufacturers to import into the United States pharmaceuticals they offer for sale outside the country at lower prices.
“The administration has reason to believe that manufacturers might use this pathway as an opportunity to offer Americans lower cost versions of their own drugs,” the agency says in its “Safe Importation Action Plan.”
“In recent years, multiple manufacturers have stated (either publicly or in statements to the administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain,” the document says. “This pathway would highlight an opportunity for manufacturers to use importation to offer lower-cost versions of their drugs.“
In a written statement on his agency’s website, Azar said: “This is the next important step in the administration’s work to end foreign freeloading and put American patients first.” The reference likely was to Trump’s complaint last year about “global freeloading” by overseas countries that pay “a tiny fraction of what the medicine costs in the USA,” while saddling U.S. manufacturers with research and development costs.