On Jan. 5, the Food and Drug Administration (FDA) announced it had approved Florida's importation plan, which will allow the state to import certain medications from Canada. Florida's plan is the first to be approved by the FDA, although at least eight other states have also submitted importation plans to the agency.
Florida must implement its plan in compliance with the requirements of the Department of Health and Human Services Safe Importation Action Plan (the “Action Plan”), which was finalized in 2020.
Although Florida’s plan has been approved by the FDA, it is unlikely to take effect in the near term. Even if Florida can meet all the Action Plan requirements, such as identifying the drugs it will import and demonstrating that it can comply with all safety requirements, including providing FDA labeling for the drugs, other stakeholders may slow proceedings. Manufacturers will likely sue to stop implementation. Further, Canada may take action to prevent implementation to protect its own limited supply.
“This drug importation proposal is not a real solution,” said Tom Kraus, ASHP vice president of government relations. “The Canadian market cannot supply anywhere close to the amount of medication needed to bring down U.S. drug prices. Patients also need to know that this approach undermines the protections that pharmacists and physicians rely on to keep our drug supply safe. We need politicians to focus on real solutions like ending pharmacy benefit manager rebates that undermine competition and discourage use of lower-cost medications, and allowing pharmacists to substitute clinically equivalent biologic medications, like they do for generic small molecule drugs.”
ASHP has long objected to state importation both because it has the potential to disrupt the pharmacist-patient relationship, particularly for patients with complex medication regimens, and because it is not a meaningful response to drug pricing.
ASHP will continue to monitor Florida’s implementation of its state importation plan and will keep members updated on new developments.