FDA Authorizes Program Allowing Import of Prescription Drugs from Canada

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has authorized a Florida drug importation program, marking the first step toward facilitating the importation of lower cost prescription drugs from Canada.¹

Announced on January 5, 2024, the authorization falls under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act pathway allows the agency to authorize section 804 importation program (SIP) proposals to import prescription drugs if there will be significant cost reductions to Americans without additional health or safety risks.

Florida's program will be authorized for two years from the date the FDA is notified of the first imported drug shipment. Before beginning the process of importation, the state’s Agency for Health Care Administration must submit additional drug-specific information for FDA review and approval, ensure the imported drugs have been tested for authenticity and compliance with FDA specifications and standards, and relabel the drugs to match the FDA-approved labeling.

“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said Robert M. Califf, MD, the commissioner of the FDA, in a statement.¹ “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

An executive order from the Biden administration on promoting competition in the American economy previously directed the health agency to work with states and Indian tribes on these plans to lower costs for American consumers while prioritizing public health and safety.

Health administrators in Florida will be required to submit a quarterly report to the FDA, including information on the imported drugs, cost savings, and any potential safety and quality issues. The FDA indicated it will exercise oversight to verify the authorized proposal is followed and Florida’s program will continue to meet the requirements in section 804 of the FD&C Act and other regulations.

Other obligations for Florida’s program under the FDA include guaranteeing supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures, and providing quarterly reports to the FDA.

The initial proposal for the drug importation program was announced in November 2020, when Florida’s Agency for Health Care Administration submitted its SIP proposal to the US Department of Health and Human Services.² At the time, Florida Governor Ron Desantis indicated the administration’s plan to work collaboratively with the federal government to deliver affordable prescription drugs to all residents in Florida.

Then, in August 2022,³ the DeSantis administration announced a lawsuit against the FDA, citing an alleged “unreasonable delay of more than 630 days in approving Florida’s proposal for its Canadian Prescription Drug Importation Program.” In the announcement, the administration reaffirmed its goal to lower drug costs for citizens in Florida with importation from Canada.

The FDA indicated all states and Indian tribes may submit SIP proposals to the health agency for review and authorization under section 804 of the FD&C Act.¹ Before authorization, the SIP proposal is required to provide all information required by the Act and the agency’s regulations.

References

1. _{Commissioner O of the. FDA authorizes Florida’s Drug Importation Program. U.S. Food and Drug Administration. January 5, 2024. Accessed January 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program.}
2. _{Governor Ron DeSantis announces Florida’s submittal of drug importation proposal to Federal Government. Florida Governor Ron DeSantis. November 23, 2020. Accessed January 5, 2024. https://www.flgov.com/2020/11/23/governor-ron-desantis-announces-floridas-submittal-of-drug-importation-proposal-to-federal-government/.}
3. _{Governor Ron DeSantis announces lawsuit against Biden Administration’s reckless delay of Canadian Prescription Drug Importation Program. Florida Governor Ron DeSantis. 31AD. Accessed January 5, 2024. https://www.flgov.com/2022/08/31/governor-ron-desantis-announces-lawsuit-against-biden-administrations-reckless-delay-of-canadian-prescription-drug-importation-program/.}