FDA Authorizes Florida’s Drug Importation Program
- January 12, 2024
The Food and Drug Administration (FDA) gave Florida the long-awaited greenlight to move forward with the state’s drug importation program, the agency announced January 5.
The approval marks the first time the FDA has approved a state’s Section 804 Importation Program (SIP) proposal. Under Section 804 of the Federal Food, Drug, and Cosmetic Act, states or tribes may submit SIPs to FDA for approval to import cheaper prescription drugs from Canada that do not increase risks to public safety.
Florida submitted its SIP to the agency in November 2020, and later went to court over the agency’s seeming lack of progress in moving the proposal forward. The FDA has now authorized Florida’s SIP for a two-year period.
“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.”
Before drug importation can begin, Florida's Agency for Health Care Administration (AHCA) must submit additional drug-specific information to the FDA for review and approval; ensure the drugs selected for importation have been tested for authenticity and compliance with the FDA-approved drugs’ specifications and standards; and relabel the drugs consistent with the FDA-approved labeling.
The AHCA also must report to the FDA quarterly on the status of the importation program, including cost savings and any potential safety or quality issues.
The initial phase of the program calls for importing prescription drugs to treat conditions such as HIV/AIDS, prostate cancer, and mental illness. The state estimates the program will save $180 million annually once fully implemented.
“After three long years of waiting for FDA approval, we are excited to finally have the opportunity to see this vision come to fruition and provide Floridians access to safe and affordable prescription drugs,” said AHCA Secretary Jason Weida in a statement.
But Pharmaceutical Research and Manufacturers of America President (PhRMA) and CEO Stephen J. Ubl called the FDA’s approval of Florida’s drug importation plan “reckless.”
“Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Ubl said.
In February 2023, a federal court dismissed a challenge brought by PhRMA and other groups to the FDA final rule establishing the Section 804 pathway for potential drug importation from Canada. At the time, the court found plaintiffs lacked standing because their alleged harm was too speculative given that the FDA had yet to approve any drug importation programs. Pharmaceutical Research and Manufacturers of Am. v. Dep’t of Health and Human Servs., No. 20-3402 (TJK) (D.D.C. Feb. 6, 2023).