Feds give 2-year approval to Florida’s Canadian prescription drug importation plan

Pill party: Clay Yarborough bill keeps drugs out of the trash.

The Joe Biden administration gave two-year approval to Florida’s plan to import certain prescription drugs from Canada, making Florida the first state to receive such approval.

The approval letter to Agency for Health Care Administration (AHCA) Secretary Jason Weida comes more than three years after the Gov. Ron DeSantis administration initially submitted its drug importation proposal to the Food and Drug Administration (FDA) for approval. Importation programs are allowed under Section 804 of the Federal Food, Drug, and Cosmetic Act.

While federal approval was a prerequisite for an importation program, it is the first step in the state’s journey to import drugs from Canada, an idea that initially was pushed by former House Speaker José Oliva and endorsed by DeSantis.

According to the letter, there is more work ahead for AHCA before the program takes off. AHCA 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; and relabel the drugs to be consistent with the FDA-approved labeling.

The federal government also will require AHCA to 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. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

That plan was modified several times, with the FDA ultimately signing off on a plan, and clarifying communications, sent Nov. 16, 2023.

The two-year time frame begins once the FDA is notified of the first shipment of drugs to be imported.

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubi issued a statement calling approval of the importation program “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,” he said. “Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients.”