Jan. 5, 2024 — U.S. regulators on Friday approved a plan to permit Florida to import drugs, calling it a move intended to permit the state to purchase drugs directly from Canada at a lower cost.
The FDA has granted approval The Florida Agency for Health Care Administration Drug Importation Program. Next, the state must meet several obligations, including proving that the drugs it desires to import have been tested for authenticity and compliance with FDA specifications and standards, amongst other things, the agency said.
This is the primary approval of a government drug importation plan. It represents a victory for lawmakers of each parties, who've for a few years seen Canadian drug imports as a solution to lower U.S. drug costs. Supporters of this idea include each Democrats and the President Joe Biden and US Senator Elizabeth Warren of Massachusetts and Republicans, like the previous president Donald Trump and Florida Gov. Ron DeSantis.
But pharmaceutical corporations within the US promised to fight the plan.
In an announcement Friday, the trade group for drug manufacturers, Pharmaceutical Research and Manufacturers of America (PhRMA), said it was considering “all options” to dam Florida's plan to import drugs from Canada.
And it's unclear how well state drug import plans would work in practice in the event that they were enacted.
Canadian officials and medical organizations have long opposed the concept of mass importation into the United States. For example, in 2020, in the course of the Trump administration, the Canadian Pharmacists Association warned the FDA that such a diversion of its drugs could be “devastating” to a rustic, worsening drug shortages and increasing drug costs.
Many people within the US are already traveling to Canada and Mexico seeking cheaper prices.
The FDA has been working on regulations for years to permit more extensive drug imports. In 2022, the agency rejected a request from New Hampshire, saying it lacked necessary information, including information in regards to the expected supplier of the drugs. Other states where lawmakers have seriously considered drug importation include Colorado, Maine, New Mexico, Ohio and Vermont, in accordance with a December 2023 report from the Texas Health and Human Services Department.
In an announcement Friday, FDA Commissioner Robert M. Califf, MD, said his agency will work with other states and Native American tribes on drug importation plans.
“These proposals must demonstrate that the programs would result in significant cost savings for consumers without increasing the risk of exposure to unsafe or ineffective medications,” he said in an announcement.