Florida continues to tangle with the FDA over Canadian drug importation

Four years after Florida lawmakers passed a plan to import cheaper prescription drugs from Canada, the plan remains snarled in disputes between the state and the U.S. Food and Drug Administration.

The state on Friday filed a lawsuit alleging that the Food and Drug Administration violated the Freedom of Information Act by not properly responding to a request for records about Florida’s attempt to get approval for the importation program.

The state also filed a similar federal lawsuit in July — a case that remains unresolved.

Gov. Ron DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug-importation issue a priority in 2019, with lawmakers approving a plan to make imported drugs available in government programs such as Medicaid, the prison system and facilities run by the Department of Children and Families. At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS, hepatitis C, diabetes and mental illness, according to court documents.

The state submitted a proposal in November 2020 to the Food and Drug Administration, which would need to approve the importation program. The proposal falls under what is known as the federal Section 804 Importation Program, or SIP.

The lawsuit filed Friday said the state on March 21 filed a Freedom of Information Act request to obtain a variety of records from the federal agency, including records related to Florida’s SIP proposal and SIP proposals made by Colorado, New Mexico, New Hampshire, Vermont and Maine.

Lawyers in Attorney General Ashley Moody’s office wrote that the federal agency acknowledged the records request but has not properly responded within legal timeframes.

“To date, the FDA has not responded to the March 2023 FOIA Request, nor provided any responsive materials to that request, nor explained that responsive materials have been or will be withheld,” the lawsuit said.

The July lawsuit similarly alleged violations of the Freedom of Information Act. In addition, the state alleged the FDA violated a law known as the Administrative Procedure Act and sought an order forcing the FDA to immediately review and decide on the drug-importation proposal.

The FDA in November requested more information from the state about the SIP proposal. Federal attorneys on April 7 asked for a stay of the July lawsuit because the Food and Drug Administration had not received the requested information.

“This stay would respect Florida’s stated intention to provide the requested materials and afford FDA the necessary time to review those materials,” the motion said. “At the conclusion of the stay period, FDA would provide the court with a status report about the anticipated decision making timeline for Florida’s updated SIP proposal.”

But in a court filing Friday, the state fired back against the stay request and said it has submitted a supplemental SIP proposal.

“Defendants ask the court to establish a precedent that agencies can delay indefinitely until sued, then rush out a lengthy and largely contrived request for information to stall the case and give the appearance of agency action, then obtain a stay of judicial proceedings on the basis that the agency hasn’t yet received a response to its enormous request — all designed to further delay an adverse judgment,” the state’s lawyers wrote. “Allowing agencies to engage in such gamesmanship undermines the judicial review mandated by Congress in the Administrative Procedure Act and creates a moral hazard for agencies.”

Both cases are assigned to Tampa-based U.S. District Judge Thomas Barber, who was appointed to the federal bench by former President Donald Trump.

In the lawsuit filed Friday, the state estimated it could save $150 million a year by importing cheaper drugs from Canada. It also said it has built a refrigerated distribution facility for the program and contracted with an importer and a distributor “currently being paid $1.2 million per month.”

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