The US Food and Drug Administration (FDA) has authorised the Agency for Health Care Administration of Florida's drug importation programme under section 804 of the Federal Food, Drug and Cosmetic (FD&C) Act.
The initiative marks a significant step towards Florida’s goal of importing prescription drugs into the state from Canada.
The move is in line with the US Government’s Executive Order on Promoting Competition in the American Economy.
The FDA's approval of Florida's Section 804 Importation Program (SIP) proposal is the first such move of its kind. It will be valid for two years from the notification to the regulator of the first shipment.
The new programme aims to provide cost savings to American consumers without compromising health and safety standards.
Florida’s Agency for Health Care Administration must now submit further drug-specific data for review and approval by the FDA.
The state should also ensure that the drugs are assessed for authenticity and comply with FDA-approved specifications.
Drugs imported to the state are required to be relabelled to align with FDA requirements.
Florida will also file a quarterly report to the FDA, detailing information about the imported drugs, any safety or quality concerns and cost savings.
The FDA will maintain oversight to ensure Florida's adherence to the programme's regulations, including supply chain integrity, adverse event reporting and compliance with drug recall procedures.
The sponsor of any FDA-authorised programme is tasked with implementing all aspects of their programme, including import and supply.
Other states and indigenous tribes interested in establishing SIPs can submit proposals to the FDA for review and approval, provided they meet the requirements of the FD&C Act and FDA regulations.
The FDA has provided a compliance guide and tips to assist sponsors in developing their proposals.
US FDA Commissioner Robert Califf stated: “The FDA is committed to working with states and tribes that seek to develop successful section 804 importation proposals.”
“These proposals must demonstrate the programmes would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
