Prescription medication approved in Canada or manufactured by drug makers who have products already approved by the FDA would get streamlined paths to U.S. markets under a new Trump administration plan.
The July 31 plan, released by the Department of Health and Human Services and the Food and Drug Administration, outlines two new policy proposals to import drugs to the U.S. that were originally intended for a foreign market. Importing drugs would expand on President Donald Trump’s goal to reduce the cost of medications for patients, the administration says.
“This is the next important step in the Administration’s work to end foreign freeloading and put American patients first,” Health Secretary Alex Azar said in a statement.
Under the first path, states, wholesalers, or pharmacists would submit an outline for how they would import certain Canadian-approved drugs to enter the U.S. The administration will pursue that policy through upcoming rulemaking.
The second path would make it easier for drug manufacturers who already have Food and Drug Administration-approved drugs to bring foreign versions of those medications into the U.S. Under coming FDA guidance, the drugs could only be imported if it is the same as the U.S. version and would have to have appropriate labeling.
Biologic drugs like insulin wouldn’t be available under the first importation pathway, acting FDA Commissioner Ned Sharpless said on a call with press. The second pathway would be open to a wider swath of drugs, he said.
Canada, however, has reportedly not been on board with an importation plan by the U.S.
Azar said he’s spoken about it with Canadian Health Minister Ginette Petitpas Taylor but didn’t address Canada’s reaction to the plan on a call with press. “Those will be issues for state, pharmacies, and wholesale distributors to work out,” Azar said.
“We’re in touch with U.S. officials and look forward to discussing today’s announcement with them,” Health Canada spokesman Alexander Cohen said. The announcement from the Trump administration “is further evidence of our commitment to more affordable prescription drugs,” Cohen said.
Canadians’ access to medication is a priority, Cohen said. Health Canada “will be working closely with health experts to better understand the implications for Canadians and will ensure there are no adverse effects to the supply or cost of prescription drugs in Canada.”
Canadian health advocates are concerned that a drug importation plan could disadvantage patients in their own healthcare system.
The prescription drug supply in Canada can’t support both countries’ markets, Canadian health organizations said in a July 25 a letter to Petitpas Taylor, arguing against importation plans brewing in the U.S. The 15 organizations who signed the letter represent groups like patients, nurses, doctors, and pharmacists.
“Hospital and community pharmacies in Canada are resourced to serve the Canadian public. They are not equipped to support to the needs of a country 10 times its size without creating important access or quality issues,” the organizations wrote.
—With assistance from Jacquie Lee