FDA Approves Florida Drug Importation Plan

The federal agency approved the importation program for two years, saying Florida had met requirements to show that it “will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.”

The plan is designed to make imported drugs available in government programs such as Medicaid, the prison system and facilities run by the Florida Department of Children and Families. At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS and mental illness.

Gov. Ron DeSantis' office said an analysis showed the program could save up to $183 million a year when it is fully in place.

Friday’s approval came after lengthy wrangling about the plan and the state filing two lawsuits against the FDA.

“They have set up a number of hoops,” state Agency for Health Care Administration Secretary Jason Weida told the House Health Care Appropriations Subcommittee last month. “We have jumped through them all.”

But the Pharmaceutical Research and Manufacturers of America, or PhRMA, criticized Friday's approval, issuing a statement that said it is "considering all options for preventing this policy from harming patients."

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan," Stephen J. Ubl, the industry group's president and CEO, said in the statement. "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."

DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug-importation issue a priority in 2019, with lawmakers approving the idea. The state submitted a proposal in November 2020 to the FDA.

That touched off a review process that included the FDA seeking revisions to the plan. The state filed a revised proposal in October to try to address the federal agency’s concerns, according to court documents.

As an example of issues that emerged during the back-and-forth, the FDA in an Aug. 14 letter pointed to Florida’s proposal lacking a secured warehouse within 30 miles of an “authorized port of entry” for prescription drugs in Canadian importation programs. The only authorized port of entry was Detroit, while Florida planned to store shipments at a facility in Whitestown, Ind.

A news release posted on the FDA website described Friday’s approval as a “first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.”

Before importation can start, the Agency for Health Care Administration has to meet conditions, such as submitting additional “drug-specific information” for FDA approval, the news release said.

Also, the news release said the Agency for Health Care Administration will have to ensure “that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.”

As the FDA review continued in 2022, the state filed a lawsuit alleging violations of the federal Administrative Procedure Act and the Freedom of Information Act. The Administrative Procedure Act allegations centered on delays in the decision-making, while the Freedom of Information Act allegations involved records that the state sought from the FDA.

The state filed another Freedom of Information Act lawsuit in 2023. Both cases remain pending in federal court in Tampa.