FDA Authorises Florida Drug Importation Programme for Canadian Medicines

In its announcement of the authorisation, the FDA described the decision as a first step rather than a green light for immediate imports. Section 804 allows the agency to authorise proposals from states and Indian tribes only where a programme would significantly reduce costs to consumers without adding risk to public health and safety.

What Florida must do before importing

Before any product can be imported, Florida must submit drug-specific information for FDA review and approval, ensure that each drug is tested for authenticity and compliance with FDA-approved specifications, and relabel the drugs to match FDA-approved labelling. Once imports begin, the state must send the FDA quarterly reports on the drugs imported, the cost savings achieved and any safety or quality concerns, and it must maintain supply chain integrity, adverse event reporting and recall procedures.

The authorisation lasts for two years from the date the FDA is notified of the first shipment. The FDA Commissioner said the agency would continue to work with states and tribes seeking to develop proposals, while stressing that each must show significant savings without added risk from unsafe or ineffective drugs.

The legal framework

The programme rests on a final rule on the importation of prescription drugs, published in the Federal Register on 1 October 2020 and effective from 30 November 2020. The rule allows states and Indian tribes, and in certain future circumstances pharmacists and wholesalers, to submit importation proposals, and it requires sponsors to demonstrate both that a programme poses no additional risk to public health and safety and that it will significantly reduce the cost of covered products to American consumers.

What it means for the industry

Manufacturers, distributors and pharmacy operators will watch how the Florida drug importation programme handles the drug-specific approvals, testing and relabelling steps, since those conditions will shape how quickly imports can start and how the model might be replicated. Other states and tribes considering section 804 proposals now have a first worked example of the conditions the FDA expects.

Sources

• U.S. Food and Drug Administration: FDA Authorizes Florida's Drug Importation Program
• Federal Register: Importation of Prescription Drugs, final rule