Donald Trump’s administration unveiled a plan Wednesday to allow for importation of lower-price prescriptions from Canada and other countries, a cost-saving goal championed by both the US president and Democratic rivals on the 2020 campaign trail.
“No president in history has ever had an FDA willing to open the door to safe importation of drugs from Canada,” Health Secretary Alex Azar said in a conference call with the press.
The Department of Health and Human Services published proposed rules and guidance Wednesday outlining two pathways to formalize the president’s plan, first laid out at the end of July.
Under a first pathway, US states would be allowed to propose importation programs for drugs already authorized in Canada, subject to approval by the US Food and Drug Administration (FDA). States bordering the United States’ northern neighbor, including Vermont and New Hampshire, are already onboard with the project.
However, the program would not include biological drugs — ones made from large or live molecules — meaning medications such as insulin, whose price is often derided as sky-high in the US, would be excluded.
The measure is subject to a 75-day comment period, after which it will need to be finalized before entering into effect.
A second pathway would allow US pharmaceutical companies to import drugs they market abroad, circumventing middlemen called pharmacy benefit managers that prevent manufacturers from lowering the price patients pay at the counter.
Foreign but identical versions of a company’s drugs, including biological drugs, could therefore be sold under a separate code at a reduced cost.
The measure, Azar said, would allow drug companies to “bring that same product in the United States to basically compete against your own product, but at a lower list price.”