The U.S. Food and Drug Administration has authorized a drug importation proposal from the Florida Agency for Health Care Administration under section 804 of the Federal Food, Drug and Cosmetic Act. This is the first step on the pathway toward Florida facilitating the importation of certain prescription drugs from Canada.
Florida’s proposal specifies drug classes including medications for patients with asthma, COPD, diabetes, HIV and AIDs, and mental illness. In addition, it would only apply to certain people, including foster children, prison inmates, elderly patients and Medicaid recipients.
President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs and support public health and safety.
Florida’s section 804 importation program (SIP) is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported. Before the drugs can be imported, Florida’s Agency for Health Care Administration (FAHCA) must:
- Submit additional drug-specific information for the FDA’s review and approval.
- Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.
- Relabel the drugs to be consistent with FDA-approved labeling.
In addition, the FAHCA must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues.
