For Immediate Release:January 05, 2024
Today, the U.S. Food and Drug Administration 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 is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.
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. Among other obligations related to this SIP, before drugs can be imported, Florida’s Agency for Health Care Administration 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 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 FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M. Califf, M.D. “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 will exercise oversight to help ensure the authorized proposal is followed and that Florida’s program continues to meet the requirements in section 804 of the FD&C Act and the agency’s regulations. Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA. The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution.
States and Indian tribes may submit SIP proposals to the FDA for review and authorization under section 804 of the FD&C Act. Prior to authorization, a SIP proposal must provide all the information required by the FD&C Act and the FDA’s regulations.
The FDA previously posted a small entity compliance question-and-answer guide and developed Tips for SIPs to assist sponsors in developing their proposals as a part of the agency’s ongoing commitment to working with interested states and tribes.