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
Donald John TrumpWhite House counsel didn’t take lead on Trump letter to Pelosi: reports Trump endorses Riggleman in Virginia House race Lisa Page responds to ‘vile’ Trump attacks: ‘Being quiet isn’t making this go away’ MORE has long supported the idea, and is searching for drug pricing victories ahead of the 2020 election.
To date, almost every administrative effort on drug pricing has been blocked in court or been withdrawn in the face of opposition.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 Secretary Alex Azar, who just last year called drug importation a “gimmick.”
Florida Gov. Ron DeSantis
Ronald Dion DeSantisSaudi officer ripped US support of Israel in tweet before naval base shooting: report The Hill’s Morning Report – Sponsored by AdvaMed – A crucial week on impeachment FBI identifies Pensacola shooter as Saudi Royal Saudi Air Force second lieutenant MORE (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.
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.
“This is the first time in history HHS and FDA are open to importation,” Azar said on a call with reporters ahead of the release of the proposed rule. “These importation proposals are a historic step forward to lower drug prices.”
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 Trump administration opposes government negotiation as a way to lower prices in the U.S.
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.
