State, Feds Tangle Over Drug Importation Plan

by | Sep 1, 2023



  • Florida is awaiting the FDA’s decision on whether it can import prescription drugs from Canada, and the state has filed two lawsuits against the FDA over issues with the approval process.
  • The FDA raised concerns about Florida’s proposal, including the lack of a secured warehouse near the authorized port of entry in Detroit, where the drugs would be stored in Whitestown, Indiana.
  • Florida officials have requested approval for a port of entry in Indianapolis, but the FDA has also raised questions about the program’s ability to ensure drug supply chain security and achieve significant cost savings for consumers. The FDA expects to make a decision by October 31.

With the U.S. Food and Drug Administration expected to decide this fall whether Florida can import prescription drugs from Canada, the state this week lashed out after federal officials raised issues such as a requirement for a secured warehouse in Michigan.

The issues are detailed in court filings in two lawsuits Florida has filed against the FDA amid a long-running effort to get approval to import cheaper drugs from Canada for state programs such as Medicaid, the prison system and facilities run by the Department of Children and Families.

As an example of the issues, 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.

“It seems defendants (federal officials) are using the requirement of a Detroit facility as a failsafe,” lawyers for the state wrote in a court filing Tuesday. “They make a secret determination of where prescription drugs must be warehoused upon entry into the United States and then — right as a state like Florida is on the cusp of receiving final approval after years of being given the run-around — announce for the very first time that the location is, unsurprisingly, in a city where the state has no facility. This kind of arbitrary and vindictive behavior epitomizes defendants’ actions over the nearly three years during which Florida’s … proposal has been pending.”

In a letter Monday to the FDA, state Agency for Health Care Administration Secretary Jason Weida and Department of Business and Professional Regulation Secretary Melanie Griffin requested approval of a port of entry in Indianapolis, which would be within 30 miles of Whitestown.

“In the meantime, Florida’s contractor LifeScience Logistics has begun searching for an additional warehouse within 30 miles of Detroit should the FDA take the patently untenable position that no other ports of entry will be authorized. … Securing another warehouse in Detroit will pose an uncalled-for delay and may result in an unnecessary increase in supply chain costs.,” the agency heads’ letter said.

The warehouse location, however, was one of several questions and objections that the FDA raised in an Aug. 14 letter to Weida. Among other things, the FDA said the proposal did not adequately describe how Florida would “assure drug supply chain security for products imported” under the program.

Also, it said the state had not adequately explained how the program “will result in a significant reduction in the cost to the American consumer of the eligible prescription drugs that the … sponsor (the state) seeks to import. The explanation must include any assumptions and uncertainty, and it must be sufficiently detailed to allow for a meaningful evaluation. Without the requested additional information, HHS (the U.S. Department of Health and Human Services, which includes the FDA) remains unable to meaningfully evaluate the relative likelihood that the … proposal would result in significant cost savings to the American consumer.”

The Aug. 14 FDA letter gave the state two weeks to provide additional information. The response Monday from Weida and Griffin indicated the state needed more time, while the court filing Tuesday by the state’s lawyers blasted the FDA’s requests — including pointing to the then-impending landfall of Hurricane Idalia.

“For years now, defendants have persistently imposed hoops for Florida to jump through, and each time Florida has called those bluffs and risen to the task,” the state’s lawyers wrote. “Florida intends to try to do so this time, as well, subject to preparing for the hurricane predicted to make landfall soon. But the increasing absurdity of the hoops imposed by defendants demonstrates that they perhaps intend to deny Florida’s … proposal no matter how much information Florida provides.”

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. 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 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 federal review continued, the state 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 FDA.

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

The FDA said this year it expects to make a decision by Oct. 31 — a date it reiterated in a court filing this month.

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