• Legal firms representing pharmaceutical and health organizations, including PhRMA and PSM, have submitted a supplement to a prior Citizen Petition, urging the FDA to withhold authorization of Florida’s proposed drug importation program.
• The supplement highlights concerns about an alleged lack of transparency in Florida’s proposal and contends that incomplete information makes it challenging to assess if the program complies with statutory and regulatory requirements.
• The pharmaceutical groups argue that Florida’s Amended Proposal does not adequately demonstrate adherence to the core criteria for authorization, posing a risk to public health and safety and failing to significantly reduce costs for consumers. 

In a supplement to a prior Citizen Petition, legal firms representing pharmaceutical and health organizations have called on the Food and Drug Administration (FDA) to withhold authorization of Florida’s proposed drug importation program.

The supplement, filed on Monday and 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 contends that purported incomplete information hinders a comprehensive assessment of whether the proposed importation scheme complies with statutory and regulatory requirements.

“This process has proven inadequate and unworkable—Florida and FDA have engaged in substantial back and forth regarding the scope and substance of Florida’s Section 804 Importation Program Proposal, which has been outside the public view and impedes the ability for affected stakeholders to submit public comment,” reads the filing.

Moreover, the pharmaceuticals assert that an Amended Proposal filed by the state does not adequately demonstrate its adherence to the core criteria for authorization set by statute – that importation poses no added risk to public health and safety and significantly reduces costs for consumers.

“Based on its review of both the April 2023 Amended Proposal and the attachments, [the] FDA identified numerous substantive deficiencies,” the document continues. “Petitioners have identified additional ways in which the April 2023 Amended Proposal fails to satisfy the criteria for authorization, such that [the] importation of prescription drugs from Canada under the April 2023 Amended Proposal would present an unreasonable risk to patients living in Florida.”

Monday’s filing serves as an attachment to a Citizen’s Petition filed in January 2021 by the pharmaceutical lobbyists that ostensibly urges the FDA to refrain from authorizing Florida’s importation plan, a desire revisited in this week’s supplement.

“For the reasons identified herein and in our Original Citizen Petition, petitioners respectfully request that FDA refrain from authorizing the April 2023 Amended Proposal,” states the supplement.

Despite the renewed challenge, Jeremy Redfern, Press Secretary for Gov. Ron DeSantis, remains confident that the proposal will be accepted later this year.

“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.”

The ‘extended changes’ reference an amended lawsuit filed by the state in August, which expanded its claims that the FDA inadequately furnished records related to Florida’s efforts to secure approval for the importation program.

Per the amended complaint, the Florida Agency for Health Care Administration (AHCA) submitted a Freedom of Information Act (FOIA) request in May, which was filed in a similar scope to previous FOIA requests made in July 2022 and March 2023 but covered a more recent timeframe.

The state contended that the FDA did not respond to the May FOIA Request within the required statutory timeframe. As a result, the plaintiffs amended their complaint to compel the agency to respond as part of the ongoing legal proceedings regarding the importation program.

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. The agency subsequently requested additional information from the state before making a decision on the SIP proposal, which will come no later than October 31.

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 Canadian Prescription Drug Importation Program. If importation rights are granted, it is expected to lower the cost of consumer medication for residents of participating states.

The lack of response resulted in a lawsuit against the FDA, asserting that the agency had “intentionally delayed the process of approval.”

The federal government denied the claim, going so far as to ask a judge to reject allegations, as well as file a 27-page document that pushed back against the lawsuit.

“Defendants deny the allegations that [the] FDA has been inactive concerning, or ‘sitting on,’ Florida’s SIP proposal, and that [the] FDA is denying access to prescription drugs,” the document reads, filed in a federal court in Tampa.

In December, New Hampshire, New Mexico, and Colorado formally joined Florida in requesting federal permission to import prescription pharmaceuticals.