Federal authorization on Monday makes Colorado the second state cleared to bring cheaper Canadian prescriptions across the border, and the real test is whether it can avoid the stall that has kept Florida's 2024 approval at zero imports.
Colorado just became the second U.S. state the FDA has cleared to import drugs from Canada. The first state to win that approval, Florida, still has not shipped a single pill two years later.
The FDA told Colorado on Monday it can move forward with a plan to bring certain prescription drugs across the border, a goal the state has chased for years under a 2020 federal rule that, for the first time, let states apply to import medicines from Canada. Colorado is the first new state to clear that hurdle since Florida in January 2024, and the authorization is the first concrete output of a process patient advocates and state drug-price reformers have pushed for more than two decades (STAT+).
That history is the reason the announcement lands with more skepticism than celebration. Florida won the same approval in 2024, and as of this week it has not imported a single drug, despite a program that state officials once said could save Floridians up to $150 million a year. Canadian industry groups warned at the time that even Florida's modest first list of drugs could strain Canadian supply, and the Canadian government has steadily pushed back against bulk export, including through its own Patented Medicine Prices Review Board. Manufacturers have separately signaled they would challenge any program they see as exposing their U.S. products to re-importation channels they have fought for decades.
The gap between an approval letter and pharmacy shelves is the real story. Federal rules require states to win FDA sign-off on three pieces after the initial authorization: a detailed drug list, safety and labeling arrangements, and a Canadian supplier willing to ship in volume. Florida cleared step one and stalled on the rest. Colorado now has to clear the same three steps, in the same order, against the same Canadian supply concerns and the same manufacturer legal pressure.
State officials in Colorado have pointed to a more disciplined rollout than Florida's, including contracted safety testing and a planned distributor. The state's initial list, when it lands, will be narrower than the full Canadian formulary and focused on high-cost brand drugs where the price gap with the United States is widest. The bigger open questions sit in Washington. The Department of Health and Human Services has to sign off on Colorado's safety and labeling plan, and the federal Coordinating Council on Importation has to bless the supply chain, two steps that have moved slowly in Florida's case.
What to watch over the next 12 to 18 months is concrete. Has Colorado locked in Canadian suppliers willing to take on the volume, and have any of them run into the same supply and political objections that helped stall Florida. Has HHS completed the safety review. Have any manufacturers filed litigation to block the program. And if imports do begin, do the savings actually reach patients at the pharmacy counter, or get absorbed by wholesalers, pharmacy benefit managers, and state contracting.
For now, the authorization is a real milestone in a fight that has produced more political energy than imports, and the question hanging over Colorado's plan is the same one Florida's plan never answered: how a state program moves from an FDA letter to a pill bottle.
Reporting referenced in this article is by Lizzy Lawrence and Ed Silverman for STAT News.