States Pushing for Canadian Drug Imports: Report

There are now four states seeking federal approval for plans to import some prescription drugs from Canada. Kaiser Health News (KHN) reports that Colorado filed its proposal on 12/5, joining Florida, New Hampshire, and New Mexico. KHN says President Joe Biden has endorsed the approach but the administration has not approved any of the state plans.

The article quotes HHS secretary Xavier Becerra as saying on 12/5 that the administration welcomes the applications from Colorado and other states, but he would not pledge that FDA would act on any of the applications in 2023. Asked what his message to states is, Becerra said, “Sign up and submit an application and we will take a look and see if you are able to get through the process.”

KHN reports that despite the administration’s public support for importation, the states that have applied have been frustrated by FDA inaction.

The report says that Florida sued the federal government in August, almost two years after submitting its application, complaining that FDA was slow-walking its application, a charge the government denied. In November, it says, FDA sent the state a 15-page letter asking it to fill dozens of gaps in its plan. In a December court filing, Florida said “suddenly conjuring so many supposed defects” in its proposal was another “stall tactic.”

A New Hampshire spokesperson told KHN its plan was rejected because it did not identify a Canadian wholesaler that would provide the drugs. The state reportedly was told it could reapply when it identified a wholesaler.

A New Mexico spokesperson said discussions with FDA on the state proposal are ongoing. FDA reportedly informed Colorado it would take six months to review its proposal.

Colorado proposes to use an Ontario, Canada, wholesaler to send drugs through Buffalo, NY, to an importer headquartered in Boise, ID. An Ohio laboratory would test the drugs before sending them to pharmacies in Colorado where they would be sold to residents and employers. Colorado said it would add safety checks for the imported drugs that go beyond those for drugs sold in the U.S. It projects savings of an average of 65% off the cost of dozens of medications, including drugs for diabetes, asthma, and cancer.

The Colorado application said the importation strategy faces not only resistance from drug manufacturers but also concerns on the part of pharmacies and the Canadian government.

KHN says other states have expressed an interest in importation but have not yet sought federal approval.