Decision in Florida’s drug importation lawsuit against FDA could come this fall

by | Jun 12, 2023

  • A judge has granted a stay on key parts of Florida’s lawsuit against the U.S. Food and Drug Administration (FDA) regarding the importation of cheaper prescription drugs from Canada.
  • The FDA expects to make a decision on Florida’s importation plan by October 31, which could render some claims in the lawsuit moot.
  • Governor Ron DeSantis and other state officials have criticized the FDA for delays in decision-making and filed lawsuits alleging violations of the Administrative Procedure Act and the Freedom of Information Act.

A judge has put on hold key parts of a lawsuit filed by Florida against the U.S. Food and Drug Administration, after the federal agency said it expects to make a decision by Oct. 31 on the state’s plan to import cheaper prescription drugs from Canada.

U.S. District Judge Thomas Barber issued an order Thursday granting the Food and Drug Administration’s request for a stay and noting that a trial is scheduled in November. The stay applies to allegations by Florida that the federal agency violated a law known as the Administrative Procedure Act in its consideration of the plan.

“Although the court understands plaintiffs’ desire to expedite this case, the court notes that this case is currently set for trial in November,” Barber’s order said. “The potential for the APA (Administrative Procedure Act) claims to become moot upon a decision from the FDA prior to trial weighs heavily in favor of staying the proceedings as to these claims to conserve judicial resources.”

Barber, however, added that the state and the FDA “should be prepared to go to trial in November should these claims not be resolved at that time.”

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 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.

DeSantis and other state officials have blasted the federal agency for not making a decision and filed a lawsuit last year alleging violations of the 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 federal agency.

The FDA last fall requested more information from the state about the SIP proposal. In a court document filed May 26, it said the state in April sent a 3,215-page supplement to the SIP proposal. The FDA said it was seeking input about the proposal from experts in numerous federal offices.

Attorneys for the FDA wrote that given “the statutory and regulatory requirements governing the SIP program and the multi-component review process that is underway,” the agency expects to issue a decision by Oct. 31.

The FDA asked for the stay in April, before Florida submitted the supplement to the proposal. Lawyers for the state opposed the stay, accusing the FDA of “gamesmanship” that would lead to further delays.

Meanwhile, the state filed a separate lawsuit in April alleging violations of the Freedom of Information Act. That case is pending before Barber, who is based in Tampa.



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