Florida gets first-ever FDA approval to import drugs from Canada

The Food and Drug Administration (FDA) on Friday approved Florida’s plan to import certain prescription drugs directly from Canada, the first time a state has ever been allowed to do so.

The approval marks a major shift in U.S. drug policy and comes despite fierce opposition from the pharmaceutical industry, which is likely to sue. The FDA has also raised safety concerns about importing drugs from outside the U.S., because it can’t guarantee their safety.

Individuals are allowed to buy from Canadian pharmacies, but states have long sought to purchase cheaper drugs directly from Canadian wholesalers.

Prescription drugs are cheaper in Canada, as in most other countries, because the government can directly negotiate the price with drug companies. 

The approval marks a political victory for both President Biden and Florida Gov. Ron DeSantis, a Republican presidential candidate, both of whom have been prioritizing lowering drug prices. 

The Trump administration in 2020 issued rules allowing states to apply for drug importation, and Florida was the first to apply. A 2021 executive order from Biden gave the policy new momentum and directed federal agencies to work with states on importation plans. 

But FDA inaction led DeSantis to sue the agency, accusing it of “reckless delay” in approving the request.

According to Florida, the state will begin by providing prescription drugs in a small number of drug classes, including medications to help individuals who have chronic health conditions such as asthma, COPD, diabetes, HIV/AIDS and mental illness. 

Only state programs, including Medicaid, the prison system and facilities run by the Department of Children & Families, would get the imported drugs.

The industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) and two other groups sued the Trump administration in 2020 over the importation effort, but the lawsuit was dismissed by a federal judge last year.

In a statement Friday, the group said it was “considering all options” for preventing the policy from happening.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan. 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. Politicians need to stop getting between Americans and their health care,” PhRMA President and CEO Stephen J. Ubl said.

“PhRMA is considering all options for preventing this policy from harming patients.”

Updated at 10:45 a.m. ET