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FLORIDA RECORD

Saturday, May 11, 2024

Federal judge stays state plan to import cheaper pharmaceuticals from Canada

Federal Court
Vater

Vater | The Ticktin Law Group.

A federal judge’s decision to pause a state plan to import cheaper prescription drugs from Canada is surprising given the number of elderly who live in Florida, according to a Tiktin law group attorney

Some 4.5 million senior citizens live in Florida, according to Statista

“Florida has an older population that is often dependent upon government programs to help pay healthcare costs,” said attorney Michael Vater who works with the Ticktin Law Group. “One would think the federal government would have a vested interest in reducing healthcare costs for those on programs.”

In the order issued on June 13, U.S. District Judge Thomas Barber stated that the stay applies to allegations that the FDA violated the Administrative Procedure Act (APA) when it reviewed 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,” wrote Barber. “The potential for the APA 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.”

The federal agency will make a decision about the plan by Oct. 31, according to media reports, and a trial is set for November.

“The Court was being pragmatic in that it was hoping not to issue a ruling which would conflict with the decision of the governmental agency,” Vater told the Florida Record. “It wanted to ensure that if the government agency was going to make a decision within a certain time period that the Court would not unnecessarily make a ruling.”

Among the factors contributing to the FDA's cautious approach in their decision-making process is a contract that was awarded to a vendor but has yet to be approved, according to Reuben Saba, vice president of medical and business affairs at Medicure, a pharmaceutical company

“National pharmacies such as Marley Drug are already providing cost-effective alternatives,” he said. “By eliminating middlemen, Marley Drug is streamlining the drug delivery process, rendering the need to seek solutions elsewhere unnecessary.”

The proposal underlying the litigation, which was submitted to the FDA in November 2020, shows that the state is seeking more affordable pharmaceuticals to treat conditions such as HIV and AIDS, hepatitis C, diabetes, and mental illness.

Health News Florida reported that the plan complies with Section 804 of the federal Importation Program (SIP).

"This case is hugely important as it affects all those seniors and others that utilize government healthcare programs, and it also is important to look at the power of states to individually negotiate deals to import cheaper pharmaceuticals," Vater added. "This case could be used as a precedent for other Courts when addressing issues brought by the state governments to compel Federal government action. It could be expanded to include other items such as immigration policy and even become a case that goes before the US Supreme Court."

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