FDA authorizes Florida drug imports from Canada
The U.S. Food and Drug Administration on Friday authorized Florida’s drug importation program of certain prescription drugs from Canada that will allow reduced prices for Americans.
The FDA agreed that the program would reduce the cost of certain drugs to the American consumer without imposing additional risk to public health and safety.
Individuals in Florida already can buy medications directly from Canadian pharmacies, but Florida Gov. Ron DeSantis has pushed to purchase drugs from Canada in bulk for its Medicaid programs, government clinics and prisons.
The FDA authorized Florida’s importation program for two years from the date the federal agency is notified of the first shipment of drugs to be imported. However, before drugs can be imported, Florida’s Agency for Health Care Administration must meet certain requirements such as submitting drug-specific information for FDA review, ensuring that the drugs have been tested for FDA-approved drugs’ specifications and standards, and relabeling the medications to be consistent with the FDA labeling.
Florida must also ensure supply chain integrity, monitor and submit adverse event reports, comply with drug recall procedures, and report quarterly to the FDA.
Florida’s Agency for Health Care Administration had been waiting for the green light from the federal government since 2019. Gov. Ron DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug-importation issue a priority in 2019, with lawmakers approving a plan to make imported drugs available in government programs such as Medicaid, the prison system and facilities run by the Department of Children and Families. The state had estimated cost savings of as much as $150 million in its first year of the program.
Congress passed a law allowing drug importation two decades ago, but federal health officials delayed implementing it for years, citing safety concerns, an argument that Florida pushed back on. DeSantis sued the FDA, accusing the agency of what he called a “reckless delay” in approving Florida’s request for approval.
Friday’s FDA authorization grew out of that lawsuit. A federal judge had set a Jan. 5 deadline for the federal agency to respond to the Florida’s application.
“They have set up a number of hoops,” Agency for Health Care Administration Secretary Jason Weida told a House panel in December. “We have jumped through them all.”
At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS and mental illness. Florida already has allocated funds to implement the drug importation program.
On Friday, the New York Times reported that the pharmaceutical industry is expected to file suit to prevent the Florida plan from going into effect.
South Florida Sun Sentinel health reporter Cindy Goodman can be reached at cgoodman@sunsentinel.com.