Today, the Food and Drug Administration approved Florida’s first-in-the-nation program to import prescription drugs from Canada, where drugs are cheaper.
Governor Ron DeSantis signed the program into law in 2019, but it required federal review and approval by the FDA, which controls prescription drug imports.
President Biden has been open to using such programs as a way to lower prices, signing an executive order in 2021 that directed the FDA to set up an approval process for states to do so.
That order rebuffed opposition from the pharmaceutical industry, which said imports would expose Americans to counterfeit or adulterated drugs. The FDA also previously worried about the safety of drugs coming from outside the U.S.
But support for importing drugs has increased in the last decade, and both parties (including former President Donald Trump) now seek to allow imports of some prescription drugs.
The FDA said Florida’s program will be authorized for two years, but imports won’t begin immediately. Under federal regulations, state officials must first test the drugs to make sure they’re authentic and relabel them so that they comply with U.S. labeling regulations.
Florida’s health department must also provide a report every three months to federal regulators about the classes of drugs imported, the money saved using imports, and any potential quality or safety 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,” said FDA Commissioner Dr. Robert Califf.
DeSantis previously sued the Biden administration for delaying approval of the import program. Five other states are still waiting for approval from the FDA.
The FDA is likely to face lawsuits over the decision from drugmakers’ trade association, which called drug imports “a serious danger to public health.”
“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” the Pharmaceutical Research and Manufacturers of America said in a statement Friday.
Although it is illegal to do so, millions of Americans already buy at least some of their medicines from pharmacies in Canada, Mexico, India, or Brazil.
FDA deliberations about how to authorize state imports from Canada began under the Trump administration.
Under current FDA rules, states can import certain medicines through pharmacies and wholesalers. Florida estimates taxpayers could save at least $150 million annually under the program the FDA just approved.
Florida’s program covers several drug classes, including medications for asthma; chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS; and mental illness.
The medications will only be provided to certain people, such as foster children, inmates, specified types of elderly patients and, after a while, Medicaid recipients.
The White House called the FDA’s action “a step in the right direction,” and invited other states to apply as well.
“For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation,” it said. “This is unacceptable.”
Like most countries, Canada sets limits on the prices drugmakers can charge if they wish to enter the market. That means drugmakers have to charge more in the U.S. to make up for the low prices charged in those other nations, in order to make enough profit to pay for research and development on new drugs.
Canadian health authorities have warned that Canada’s prescription drug market is too small to have any serious impact on U.S. prices.
