Florida Sues FDA to Speed Up Canadian Drug Import Approval

TAMPA, Fla. — Florida’s governor announced Wednesday his state is suing the Food and Drug Administration to speed up permission to import drugs from Canada.

Canadian drugs for diabetes, hepatitis C and other common illnesses are less expensive than most drugs purchased in the United States.

Florida, Colorado and other states have applied to the FDA to import Canadian drugs under a program started during the Trump administration. It’s called the Canadian Prescription Drug Importation Program.

Florida’s Agency for Health Care Administration applied for the permission 21 months ago. The delay in FDA approval prompted the lawsuit filed Wednesday in U.S. District Court in Tampa.

“Certain critical prescription drugs can cost Florida almost $400 per pill, putting a significant strain on its health care budget,” the lawsuit says. “The United States has some of the highest prescription drug prices in the world. On average, those prices are 218% of their Canadian counterparts.”

Florida Gov. Ron DeSantis, who was an advocate for the Canadian importation program, says the drug imports would save Florida residents about $150 million a year on their medical prescriptions.

The Canadian government enforces price controls on drug sales and has eliminated middleman organizations, such as pharmacy benefit managers, that are accused of driving up costs.

President Joe Biden agreed the program was worthwhile. He issued an executive order in July 2021 directing the FDA to proceed with it.

FDA officials say they are reviewing the safety of the drugs before they issue any import approvals.

Florida’s Agency for Health Care Administration made several requests to the FDA on the status of their application. In July, the state agency filed a Freedom of Information Act request for an update but the FDA has not yet responded.

DeSantis cited the lack of information from the FDA as a contributing issue for the state’s lawsuit.

“The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation,” DeSantis said in a press statement. “Florida is confident in our importation model, and we continue to look for more ways to lower drug costs for Floridians while the FDA delays approval of this importation proposal.”

The state built a refrigerated distribution facility for the Canadian drugs in anticipation of the FDA approval. The Agency for Health Care Administration reports Florida is paying an importer $1.2 million a month for the facility.

Other infrastructure for storage and distribution of the drugs cost the state $40 million. It included an empty warehouse where DeSantis held a press conference Wednesday to announce the lawsuit.

Agency for Health Care Administration officials say the Florida contract with Canadian pharmaceutical companies could be worth billions of dollars. It would become a primary source of drugs for the state’s 5.4 million Medicare recipients.

“With each passing day, the complacency of the federal government continues to appear to be a ruse to protect the pharmaceutical industry’s power over patients,” said Agency for Health Care Administration Secretary Simone Marstiller.

The FDA declined to comment on the lawsuit when contacted by The Well News.

Colorado also is trying to move forward with Canadian drug imports. While the state awaits FDA approval, state health officials announced last month that they finalized agreements with companies to manage the transactions.

The Colorado Department of Health Care Policy and Financing signed contracts with AdiraMedica, a wholesaler whose Canadian subsidiary will act as the exporter; Premier Pharmaceuticals, an Idaho-based wholesaler that handles imports and distribution; and Rocky Mountain Poison and Drug Safety, which will monitor drug safety.

The Biden administration has tried to address health care costs that include drugs when the president signed the Inflation Reduction Act last month. One part of it sets aside $70 billion to subsidize health insurance premiums, mostly for low-income persons. 

The Florida lawsuit is State of Florida et al. v. Food and Drug Administration et al., case number 8:22-cv-01981, in the U.S. District Court for the Middle District of Florida.

Tom can be reached at [email protected] and @TomRamstack