(The Center Square) – Florida on Tuesday filed a brief in support of the Biden’s administration’s petition to dismiss a federal lawsuit blocking the launch of a Canadian prescription drug import plan state lawmakers adopted in 2019.
In a brief filed Friday, the White House argued the November lawsuit filed by Pharmaceutical Research & Manufacturers of America (PhRMA), Partnership for Safe Medicines and Council for Affordable Health Coverage is premature because the federal government has not signed off on any state-based drug import programs.
The administration maintains ‘Big Pharma’s” lawsuit filed in U.S. District Court in the District of Columbia “preemptively launched this wholesale attack” on two proposed programs – Florida and New Mexico – awaiting approval by the U.S. Department of Health & Human Services (HHS) and Food & Drug Administration (FDA).
“No timeline exists for the agency to make a decision,” the motion states.
The lawsuit was filed the same day Florida’s proposed Canadian Prescription Drug Importation Program plan was submitted for final FDA review after then-HHS Secretary Alex Azar approved implementing it under Section 804 of the Federal Food, Drug & Cosmetic Act.
In 2019, Florida lawmakers adopted House Bill 19, which created three state-backed programs to import lower-cost prescription drugs. Establishing such a program was one of DeSantis’ first announced priorities upon assuming office in January 2019.
HB 19’s three prescription drug importation programs are:
- the Canadian Prescription Drug Importation Program managed by the AHCA;
- the International Prescription Drug Importation Program managed by the Department of Business and Professional Regulation (DBPR);
- a pilot program run by the Florida Department of Health and DBPR.
In 2020, lawmakers adopted HB 23, which creates an intergovernmental structure administered by the Florida Agency for Health Care Administration (AHCA) to purchase pharmaceuticals from Health Canada, and earmarked $20.4 million in the budget to hire a contractor to get the program off the ground.
On Tuesday, DeSantis and the AHCA filed an Amicus brief in support of the Biden administration’s motion, noting former President Donald Trump directed HHS to implement Florida’s plan under the 2003 Medicare Prescription Drug, Improvement & Modernization Act.
“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,” DeSantis said. “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.”
The state’s brief dismisses the suit’s contention that the federal government has failed to demonstrate the safety of importing medicine and that it would produce any actual cost savings.
“Florida’s importation plan complies with all FDA regulatory requirements and provides Floridians access to essential medications at significant cost savings to taxpayers,” AHCA Secretary Simone Marstiller said. “Our filing reiterates the governor’s commitment to safely importing lower cost prescription drugs from Canada.”
The AHCA maintains “Florida is well-equipped to ensure the safety and quality of imported Canadian drugs” with preexisting regulatory framework to “prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs.”
DeSantis on Friday said the 2019 drug importation plan could save Floridians $150 million annually in drug costs. He called on the Biden administration to accelerate final approvals so the state can launch the program within weeks.
“It is disappointing that the FDA appears to have no timeline to review any state importation proposals as referenced in today’s filing,” he said. “Floridians have been waiting long enough for lower drug prices, and there is no good reason to keep them waiting.”