Florida’s Drug Importation Program Authorized by the FDA

According to a Jan. 5 press release, the U.S. Food and Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This act signifies the first step toward Florida facilitating importation of certain prescription drugs from Canada.

The press release states that “Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. 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 to American consumers while supporting public health and safety.”

Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported. Including other requirements related to this SIP, before drugs can be imported, Florida’s Agency for Health Care Administration must:

• Submit additional drug-specific information to the FDA for review and approval
• Ensure that the drugs Florida requests to import have been tested for authenticity  and compliance with the FDA-approved drugs’ specifications and standards
• Relabel the drugs to be uniform with the FDA-approved labeling

“In addition, Florida’s Agency for Health Care Administration must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues,” the press release adds.

FDA Commissioner Robert M. Califf, MD, was quoted in the release saying that “The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals. These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

The FDA has the full press release.