Today, at the direction of Governor Ron DeSantis, the Florida Agency for Health Care Administration (AHCA) filed an Amicus brief in support of the U.S. Department of Health and Human Services (HHS) final rule implementing Section 804 of the Federal Food, Drug and Cosmetic Act, to facilitate the importation of prescription drugs, based in part off Florida’s 2019 importation concept paper.
In 2019, at President Donald J. Trump’s direction, HHS was tasked to work diligently with Florida to fully implement provisions of the 2003 Medicare Prescription Drug, Improvement, and Modernization Act related to the importation of Canadian prescription drugs.
Before HHS could issue the final rule, Congress required the Secretary of HHS to certify that the implementation of Section 804 would: (1) pose no additional risk to the public’s health and safety; and (2) result in a significant reduction in the cost of covered products to the American consumer.
Then-Secretary Alex M. Azar II provided the requisite certification. In September 2020, after working collaboratively with the State of Florida, HHS and the Food and Drug Administration promulgated a rule to implement the program that Florida’s 2019 importation concept directly influenced.
On November 23, 2020, the Pharmaceutical Research & Manufacturers of America (PhRMA), the Partnership for Safe Medicines, and the Council for Affordable Health Coverage filed suit, challenging the final rule. That same day, Governor DeSantis announced that AHCA submitted its comprehensive Section 804 Importation Proposal (SIP) to HHS.
On Friday, Governor DeSantis called on the Biden Administration to approve Florida’s proposal.
“Today’s filing reinforces Florida’s position — that the lawsuit is another desperate attempt by Big Pharma to prevent the importation of safe and effective prescription drugs from Canada,” said Governor Ron DeSantis.“Floridians have been waiting long enough for lower prescription drug prices, and it is unnecessary to keep them waiting. I look forward to the dismissal of the suit and the immediate approval of Florida’s plan by the federal government.”
“Florida’s importation plan complies with all FDA regulatory requirements and provides Floridians access to essential medications at significant cost savings to taxpayers,” said AHCA Secretary Simone Marstiller. “Our filing reiterates the Governor’s commitment to safely importing lower cost prescription drugs from Canada.”
In its Amicus brief, AHCA respectfully requests the Court to dismiss plaintiffs’ claims because the plaintiffs have not established standing. AHCA also refutes plaintiffs’ claims that the final rule itself (and HHS’ certification of the final rule) are contrary to law. Additionally, AHCA addresses how Florida is well-equipped to ensure the safety and quality of imported Canadian drugs. Florida has a preexisting regulatory framework to “prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs” and is establishing procedures for the robust testing of imported drugs. Florida is also putting into place a plan to address potential recalls of imported Canadian drugs.
Florida’s Canadian Prescription Drug Importation Program is phased to ensure safety and compliance with all FDA guidelines, serving as the national model for the upwards of 20 states who are pursuing Canadian drug importation.
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