FDA gives Florida green light to import drugs in bulk from Canada

For the first time, the U.S. Food and Drug Administration has authorized a Florida program to import certain prescription drugs in bulk from Canada. 

The approval paves the way for other states to request permission to import medications from Canada, where drug prices are much cheaper, to significantly cut costs for American consumers. 

Floria’s proposal specifies a number of drug classes, including medications for asthma; chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS; and mental illness. The medications would be only for certain people, including foster children, prison inmates, certain elderly patients and, eventually, Medicaid recipients.

Republican Gov. Ron DeSantis signed the plan into law in 2019, but it required federal review and approval by the FDA, which controls prescription drug imports.

President Joe Biden has backed such programs as a way to lower prices, signing an executive order in 2021 that directed the FDA to work with states on imports.

DeSantis celebrated the FDA’s move Friday, saying that the program will save the save up to $180 million in its first year alone by brining lower cost drugs to Floridians. 

“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”

Sharply higher U.S. drug prices

The state of Florida asserts that some medications are so costly — priced at nearly $400 per pill — that its health care budget is strained. On average, American drug costs are 218% of prices in Canada.

Florida has estimated that the program could save it up to $150 million annually. The FDA authorized the state’s importation program for two years once the agency is notified of the first shipment of drugs ordered from Canada. State officials must first test the drugs to make sure they’re authentic and relabel them so that they comply with U.S. standards.

Florida’s Agency for Health Care Administration, which oversees Medicaid in the state, will be required to provide the FDA with a quarterly report that includes information about any imported drugs, cost savings, and potential safety and quality issues. 

“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.

U.S. pharmaceutical industry lobbyists have long opposed bulk importation programs and are expected to try to block the Florida program’s implementation. 

The Pharmaceutical Research and Manufacturers of America (PhRMA), the main drug industry lobbying group in the U.S., said in a statement Friday that it strongly opposes the FDA’s decision.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA President and CEO Stephen J. Ubl said. “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 added that “PhRMA is considering all options for preventing this policy from harming patients.”

Another advocacy group, the Partnership for Safe Medicines, which protects consumers against counterfeit and other unsafe prescription drugs, is also staunchly opposed to the FDA’s move, arguing that it will put American consumers’ health at risk.

“The United States government’s decision to approve Florida’s Canadian drug importation plan weakens our nation’s safe drug supply, putting American patients at risk,” Shabbir Safdar, the group’s executive director, said in a statement Friday. “This decision breaks our closed loop system and opens the door to counterfeiters and others who will be more than happy to meet demand.”

—The Associated Press contributed to this report.