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. 

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

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.

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.”