The Trump administration is laying the groundwork to allow some cheaper prescription drugs to be imported from Canada.
The administration is issuing a proposed rule, along with a proposed guidance for the drug industry, that will allow states, pharmacies, wholesalers and manufacturers to import prescription drugs if they meet conditions designed to ensure that the importation poses no additional risk to safety and will save consumers money.
Importing drugs from abroad is a departure from the traditional Republican approach, but President Trump has long supported the idea, and is searching for drug pricing victories ahead of the 2020 election.
Administration officials announced the plan on Wednesday, the same day the House planned to vote to impeach the president, and made a point to say they would not let partisanship distract them from delivering savings for Americans.
But President Trump has struggled to find wins. To date, almost every administrative effort on drug pricing has been blocked in court or been withdrawn in the face of opposition.
The move also marks an about-face from Health and Human Services (HHS) Secretary Alex Azar, who just last year called drug importation a “gimmick.”
Florida Gov. Ron DeSantis (R), a staunch Trump ally, has been a key force in pushing for the administration to consider importation, and has spoken with Trump numerous times about the issue. Florida is a key battleground state for Trump in 2020, and Azar formally unveiled the proposal Wednesday morning at an event alongside DeSantis.
But there is also bipartisan interest in drug importation. The administration’s blessing could pave the way for states such as Vermont, Colorado and Maine to begin drug importation. All of those states have passed laws that would allow the importation of prescription drugs from across the northern border.
“For the first time in history, HHS and [the Food and Drug Administration] FDA are open to importation as a means to lower drug prices,” Azar said on a call with reporters ahead of the release of the proposed rule. “No president in history has had an FDA willing to open the door to safe importation of drugs from Canada.”
States have tried to allow drug importation in the past, but HHS has never signed off on the plans.
Prescription drugs are cheaper in Canada, as in most other countries, because the government can directly negotiate the price with drug companies.
The administration has pursued various methods to try to lower drug prices, and the importation announcement comes just a week after the House passed Speaker Nancy Pelosi‘s (D-Calif.) sweeping legislation allowing Medicare to negotiate drug prices. The Trump administration opposed that legislation, instead throwing its support behind a bipartisan Senate bill that is struggling to gain GOP supporters.
In a statement, Pelosi said the White House was “tip-toeing around Big Pharma with a spectacularly pinched and convoluted proposal that excludes insulin and has no actual implementation date.”
Azar outlined two potential pathways that could allow Americans to purchase cheaper drugs from Canada.
The first would require states, potentially working with wholesalers or pharmacies, to submit to the FDA an importation plan for select drugs that are similar to ones already approved by U.S. regulators.
But that pathway would not allow the importation of some of the most expensive drugs, like insulin, or biologics like Humira.
A second pathway would let drugmakers import cheaper versions of their own drugs, so long as the drug has also been approved in the U.S.
Azar said this pathway would give manufacturers new flexibilities to lower the list price of their medication, allowing them to sell it for cheaper.
But even with the White House on board, the states will need to overcome hurdles, starting with the massive lobbying effort by the drug industry.
Critics argue the drugs come from unverified sources and could be tainted.
“These dangerous proposals threaten the safety of patients without delivering the savings they promise and would likely come at a high cost to the state,” according to a blog from the industry group PhRMA.
Azar said having wholesalers import drugs from Canada is also not the same as people ordering foreign drugs online, and cautioned against what he called “personal importation.”
“That is not what we are working to authorize,” Azar said. “I must caution that when one goes online and buys drugs that are supposedly from a Canadian drug store, you are taking your lives into your own hands. These drugs could be coming from China, or any other country.”
Another major obstacle is Canada. It’s not clear if the U.S. will find a willing partner in Canada; the Canadian government’s support of drug importation would be crucial for the proposal to take off.
Trump administration officials did not immediately say if they had spoken with their Canadian counterparts about the proposal.
Some of the country’s top medical associations have been lobbying against the proposal. Canadian officials said they are concerned that U.S. plans to import their drugs could result in high prices and potential shortages.
In a statement to The Hill, Alex Cohen, a spokesman for Canada’s Minister of Health, said importing drugs from Canada won’t lower prices for Americans.
“We continue to be in communication with the White House and the U.S. Department of Health and Human Services and our message remains firm: we share the goal of ensuring people can get and afford the medication they need – but these measures will not have any significant impact on prices or access for Americans. We remain focused on ensuring Canadians have access to the medication they need,” Cohen said.