FDA decision on Canadian drug importation faces delay, agency cites revised proposals

by | Oct 26, 2023

  • The FDA stated it won’t decide on Florida’s Canadian pharmaceutical drug importation plan by the previously set October 31 deadline due to Florida’s failure to provide supplemental materials to its proposal.
  • Florida has met with FDA officials multiple times since the initial request for more information. The state says these meetings often led to additional requests and requirements from the FDA.
  • The state’s proposal has faced challenges, with various legal firms and organizations pointing to deficiencies and a lack of transparency.

The U.S. Food and Drug Administration (FDA) stated in a court filing this week that it no longer anticipates the issuance of a decision regarding Florida’s proposed Canadian pharmaceutical drug importation plan before the premeditated October 31 deadline.

In a status report filed with the U.S. District Court for the Middle District of Florida Tampa Division, the FDA indicated that it was unable to bring forth a decision due to the state’s failure to present additional materials to supplement its proposal.

“As Defendants previously informed the Court, on August 14, 2023, FDA requested that Florida provide certain critical information missing from its proposal,” reads the report. “As long as Florida provided the missing information, or declined to provide any further materials, by August 28, 2023, the date noted in the August 14th request, FDA still anticipated issuing a decision on the proposal by October 31, 2023.”

The FDA subsequently detailed that the state did not provide additional information, but rather sought a meeting with the agency to clarify aspects of the requested materials. The department also asserted that during a meeting on September 29 between the entities, Florida indicated that it would submit an amended proposal by October 29, though it has yet to receive such documents.

“As long as Florida provided the missing information, or declined to provide any further materials, by August 28, 2023, the date noted in the August 14th request, FDA still anticipated issuing a decision on the proposal by October 31, 2023,” writes the FDA.

The FDA told the court in the filing that if the state submits information that adequately addresses the issues it identified during an August meeting with the state, it anticipates being able to render a decision within 60 days of receiving the new proposal.

Attorneys representing the state acknowledged the delay of decision in a Status Report submitted three days after the FDA’s filing.

“Given the delay while Plaintiffs 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 state wrote in its Status Report.

The plaintiffs also corroborated that since the initial request for information issued by the FDA, they have met with agency officials on numerous occasions, though contend that the convenings typically culminated in additional conditions.

“As Plaintiffs noted in a prior status report, the FDA sent a request for information in August 2023 that included new additional requirements,” they stated. ” Since then, Plaintiffs have met several times with FDA officials, which often led to more requests and requirements. As recently as October 16, 2023, for example, the FDA sent a PDF with new requirements for labeling imported drugs.”

Per the attorneys, the state submitted an amended proposal on October 20.

Gov. Ron DeSantis announced last August that his administration filed a lawsuit against the FDA in response to an alleged delay of 630 days in approving Florida’s proposal for its importation program. If importation rights are granted, it is expected to lower the cost of consumer medication for residents of participating states.

Last month, The FDA submitted a supplemental status report in which it identified supposed deficiencies in Florida’s proposal, particularly related to drug supply chain security, product identifiers, and cost reduction for consumers.

Moreover, legal firms representing pharmaceutical and health organizations last month called on the FDA) to withhold authorization of Florida’s proposal.

The supplement, representing the Pharmaceutical Research and Manufacturers of America (“PhRMA”), Partnership for Safe Medicines (“PSM”), and the Council for Affordable Health Coverage, points to an alleged lack of transparency in the state’s crafting of its proposal. The document asserts that purported incomplete information hinders a comprehensive assessment of whether the proposed importation scheme complies with statutory and regulatory requirements.

Despite the renewed challenge, Jeremy Redfern, Press Secretary for DeSantis, remained confident that the proposal will be accepted later this year, upon outreach efforts in September.

“This petition just makes the case that we are doing the right thing,” Redfern told the Capitolist. “Despite Big Pharma’s objections and the Biden Administration’s reluctance, Governor DeSantis will continue to lead the fight to lower prescription drug prices for Floridians.”


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