On Friday, January 5th, 2024, the FDA authorized Florida’s drug importation program, signaling the first step towards Florida’s facilitation of importing prescription drugs from Canada. The FDA was directed by Executive Order to work with states as well as Indian tribes to reduce the cost of medications without additional health and safety risks to the consumer. To that end, the Section 804 importation program, also known as SIP, provides a pathway by which the Federal Food, Drug, and Cosmetic Act (FD&C Act) can allow the importation of prescription drugs from Canada.
The importation program would impact state-run drug programs, such as Medicaid and the state prison system. As such, there wouldn’t be a direct financial impact on individual patients, but the savings would be accrued by the state government. Florida must meet additional requirements before medications can be imported, including supplying drug-specific information to the FDA, ensuring the imported medications have been tested for authenticity, and relabeling medications consistent with FDA-approved labeling. There are also ongoing reporting requirements about safety, quality, and cost savings.
Canada remains in opposition to the mass importation of medications into the United States and is taking steps to ensure drug supply and prevent shortages for Canadian citizens. Drug manufacturers are also expected to continue efforts to prevent importation and a resulting impact on their bottom line. This may include monitoring historical utilization patterns and limiting the sales of medications to Canadian entities if increased medication demand is thought to be a result of importation.
Dr. Jeff Eichholz is the Director of Pharmacy Solutions for McGohan Brabender. If you have a question or topic you would like addressed, you can email him at email@example.com.