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The FDA's decision on Canada drug imports to Florida faces a delay past October

The FDA building in Silver Spring, Maryland.
AP
The FDA would need to approve the drug importation program. The proposal falls under what is known as the federal Section 804 Importation Program, or SIP.

The FDA had been expected to decide by next week, but a back-and-forth between state and federal officials about details of the proposal means the wait will continue, a court document says.

Florida likely will have to wait a little longer to find out if it will be able to import cheaper prescription drugs from Canada.

The U.S. Food and Drug Administration had been expected to issue a decision by the end of October about the proposed program, which the state has been pursuing since 2019 and has spawned two lawsuits.

But a court document filed this week said a back-and-forth between state and federal officials about details of the proposal will prevent a decision this month. The document, filed Monday by attorneys for the Florida Agency for Health Care Administration, said the state submitted a revised proposal Friday to try to address additional questions raised by the FDA.

“Given the delay while plaintiffs (the state) had to compile materials to address the changing requirements, plaintiffs understand the FDA is unlikely to be able to issue a decision by their previously stated date of October 31, 2023,” the document said.

Similarly, in a court document filed Friday, the FDA said it “no longer anticipates issuing a decision by October 31” because of state revisions to the proposal.

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.

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

But as the FDA review continued, the state filed a lawsuit last year alleging violations of the federal Administrative Procedure Act and the Freedom of Information Act. The Administrative Procedure Act allegations center on delays in the decision-making, while the Freedom of Information Act allegations involve records that the state sought from the FDA.

The state filed another Freedom of Information Act lawsuit this year. Both cases remain pending.

After the FDA said it expected to make a decision by Oct. 31, U.S. District Judge Thomas Barber issued a stay of the Administrative Procedure Act proceedings.

The document filed Monday by the state’s attorneys said the two sides were “discussing a proposal that would ask the court to keep the APA (Administrative Procedure Act) claims stayed for a brief period so the FDA can review Florida’s amended SIP Proposal, at which point plaintiffs are confident the FDA will approve the proposal.”

As an example of issues that have arisen during the review of Florida’s proposal, 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 is Detroit, while Florida planned to store shipments at a facility in Whitestown, Ind.

Court documents said state and federal officials have held meetings and exchanged questions and responses since the Aug. 14 letter, leading to the state filing the revised proposal last week. The state filing Monday indicated one of the issues involved labeling requirements for imported drugs.

Jim Saunders is the Executive Editor of The News Service Of Florida.