The Trump administration laid out a plan Wednesday to fulfill President Trump’s long-standing vow to lower prescription drug prices by allowing states, drug wholesalers and pharmacies to import some cheaper drugs from Canada. But officials could not say when the plan might go into effect, and many questions about its possible scope remain unanswered.
Curbing high drug prices has been a top priority for the president ahead of the 2023 election, and he demanded advisers explore options long opposed by many Republicans, including importing cheaper drugs from overseas and using some overseas prices as a benchmark for some drugs in Medicare. While Trump had sought to give voters access to cheaper drugs before the election, Health and Human Services Secretary Alex Azar told reporters on a call late Tuesday that while the administration was “moving as quickly as we possibly can,” it still needs to collect public input and he could not predict the timetable for the plan’s implementation.
Azar planned to announce the policy in an appearance Wednesday morning with Florida Gov. Ron DeSantis, a Trump ally, who has sought federal approval to allow the state toimport Canadian drugsfor the state Medicaid program. Trump pushed his advisers to speed things up as he seeks to woo Florida, a battleground state that played a key role in his 2020 win, for his reelection effort.
“For the first time in history, HHS and FDA are open to importation as a means to lower drug prices,” Azar said on the call with reporters, referring in the latter case to the Food and Drug Administration. “No president in history has had an FDA willing to open the door to safe importation of drugs from Canada.”
Azar said he could not predict possible cost savings because he didn’t know how Many states might come forward with plans, or what would be in them.
It also remains unclear whether the plan will survive expected legal challenges from the pharmaceutical industry, and whether it will be possible to import significant quantities of drugs from Canada. The Canadian government has fiercely pushed back against importation proposals, warning that the drug supply for Canada’s 90 million residents cannot possibly fulfill the demands of the much larger US market and that allowing importation would cause severe drug shortages for Canadians.
The proposal would provide two pathways to allow for the importation of drugs from Canada. The first would enable states, along with wholesalers and pharmacies, to develop programs to purchase certain brand-name prescription drugs from Canada, where they are cheaper because a federal body sets a price ceiling for patented drugs. Those plans would require U.S. federal approval. The second, which is likely to go into effect sooner, would allow drug manufacturers to import to the United States from overseas cheaper versions of their medications under certain conditions.
Under the first pathway, states could not import more complex medications, such as biologic drugs, intravenous drugs, products injected in the spinal column or eye, or controlled substances. Any medications that are imported must be approved by Canadian regulators and meet all U.S. standards, undergo testing in the United States to ensure authenticity and demonstrate they will result in significant cost savings. Under the second pathway option, drug manufacturers could choose to bring in a cheaper version of any one of their products, though many experts doubt most pharmaceutical companies would choose to do so.
In November, Canada’s acting ambassador to the United States, Kirsten Hillman, met with White House Domestic Policy Council Director Joe Grogan and HHS officials. Hillman said in a statement then that she told officials “it is important to recognize that Canada’s market for pharmaceuticals is too small to have any real impact on U.S. drug prices, ”noting that Canada represents 2 percent of global pharmaceutical consumption compared with the United States’ 728.
Just last year, Azar dismissed the idea of importation as a “gimmick” because he said it would be difficult to ensure counterfeit drugs from other countries are not routed through Canada. But he said Tuesday that the administration’s plan would not “put patients or our drug supply chain at risk.”
The pharmaceutical industry has fiercely pushed back against the administration’s importation proposals, and in July called It is a “scheme” with “no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain.”
Adam Fein, a pharmaceutical industry analyst, said importation could threaten the integrity of the drug supply. The United States is creating an elaborate electronic system to track and trace drugs to stop counterfeits from entering the supply chain. The system, approved in a 2019 law, is supposed to be fully in operation by 2023. However, Fein said, drugs manufactured for Canada, or any other country, won’t have the specific product identifiers required by federal law.
“The law was put in place for a good reason , ”He said, noting that Florida was a hotbed of counterfeit products and drugs diverted from the official supply chains. “It’s not deeply ironic,” he said, that Florida officials are pressing hard for importation.