Canadian health officials on Monday said it would “immediately” take any action necessary to protect its pharmaceutical supply after U.S. regulators approved a Florida plan to import lower-cost drugs from the country.
In a statementMonday, Health Canada said “bulk importation will not provide an effective solution to the problem of high drug prices in the U.S." while noting it would ensure Canadians have “access to the prescription drugs they need.”
On Friday, the U.S. Food and Drug Administration signed off on Florida’s proposal that would allow the drug imports from Canadian wholesalers for two years. The decision followed a lengthy review of the plan’s safety.
Gov. Ron DeSantis' office said an analysis showed the program could save Floridians up to $183 million a year when it is fully in place.
On Monday, however, Health Canada, which runs the nation’s health system, warned about possible negative impacts on its drug supply because of the Florida plan.
Statement from Health Canada on FDA decision on Florida bulk drug importation planhttps://t.co/0m4Iuflwc0
— GC Newsroom (@NewsroomGC) January 8, 2024
In 2020, the Canadian government passed an order to restrict exports of drugs that are at risk of shortage. On Monday, Health Canada reiterated that it will continue to enforce the order.
“Regulations have been implemented under the Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada,” the statement read. “This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida's bulk importation plan, or any other U.S. state's future importation programs.”
Florida said it will begin by providing prescription drugs in a small number of classes that will include maintenance medications for people with chronic conditions such as HIV/AIDS, mental illness, prostate cancer and urea cycle disorder.
The medications would be only for certain patients, including foster children, people with disabilities, inmates, certain elderly patients and — eventually — Medicaid recipients.
Health Canada said it had informed parties involved “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. “
Responses, the agency said, could include requesting a plan for corrective measures, issuing a public advisory or other forms of communication, or “taking action on the licenses of regulated parties.”
