By Jim Saunders ©2024 The News Service of Florida
TALLAHASSEE — U.S. and Canadian officials this month discussed the Biden administration’s approval of a Florida plan to import cheaper prescription drugs from Canada, which is concerned about safeguarding its drug supply.
The U.S. Department of Health and Human Services issued a summary Monday about a Jan. 12 discussion between U.S. Secretary of Health Xavier Becerra and Canadian Health Minister Mark Holland.
“During the call, they agreed to continue to discuss mechanisms and strategize on finding solutions to combat increasing drug prices to ensure that both Americans and Canadians have access to an affordable and stable drug supply,” the summary said. “Secretary Becerra and Minister Holland committed to keeping in close contact to ensure a mutually beneficial path forward.”
But the Canadian agency Health Canada last week issued a more sharply worded summary of the discussion. It said Holland has “spoken to senior U.S. officials to express Canada’s disappointment with the FDA (U.S. Food and Drug Administration) decision and to advise that Canada will take all necessary measures to protect the Canadian drug supply.”
“I want to assure Canadians that they will continue to have access to medications they need when they need them,” Holland said in a prepared statement. “Canada has strong regulations in place to protect supply. Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”
The Food and Drug Administration on Jan. 5 gave a first-of-its-kind approval that would allow Florida to import drugs from Canada. At least initially, the drugs would go to programs operated by the state Department of Corrections, the state Department of Children and Families and the state Agency for Persons with Disabilities and would be medications used to treat conditions such as HIV and AIDS, mental illness and prostate cancer.
The state Agency for Health Care Administration said Jan. 5 that the importation plan would save $180 million in the first year.
But the Canadian government quickly raised concerns and tried to reassure the country’s residents that drug supplies would be protected.
“The department (Health Canada) has informed regulated parties of their obligations under Canadian regulations, including the requirement to not distribute a drug to another person for consumption or use outside Canada unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or worsen a shortage of the drug in Canada and has retained detailed records of the information relied upon to make that determination,” Health Canada said in a Jan. 8 statement. “The department will not hesitate to take immediate action to address non-compliance, ranging from requesting a plan for corrective measures, issuing a public advisory or other forms of communication, to taking action on the licenses of regulated parties who contravene the export prohibition if warranted.”
The FDA approval of the importation plan came almost five years after Florida began pursuing the idea — and after legal clashes between Florida and the Biden administration.
Gov. Ron DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug-importation issue a priority in 2019, with lawmakers approving the idea. The state submitted a proposal in November 2020 to the FDA.
That touched off a review process that included the FDA seeking revisions to the plan. As the review continued in 2022, the state filed a lawsuit alleging violations of the federal Administrative Procedure Act and the Freedom of Information Act. The Administrative Procedure Act allegations centered on delays in the decision-making, while the Freedom of Information Act allegations involved records that the state sought from the FDA. The state filed another Freedom of Information Act lawsuit in 2023.
In announcing its decision this month, the FDA described the approval as a “first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.”
Before importation can start, the Agency for Health Care Administration has to meet conditions, such as submitting additional “drug-specific information” for FDA approval, the federal agency said in a news release.
Also, the news release said the Agency for Health Care Administration will have to ensure “that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.”
