The US Food and Drug Administration (FDA) has authorised Florida’s first-of-its-kind request to directly import cheaper prescription drugs from Canada.
Prescription drug pricing has been an ongoing issue in the US, which is reportedly spending more than double the average amount spent by other OECD member countries on prescription medicines per capita.
Florida’s Canadian Prescription Drug Importation Program, which will initially focus on a small number of drug classes to treat conditions such as HIV/AIDS, diabetes and prostate cancer, is expected to save the state up to $180m in its first year.
The plan will be authorised for two years from the date the FDA is notified of the first shipment of drugs to be imported, the regulator said.
Before drugs can be imported, however, the state’s Agency for Health Care Administration (AHCA) must comply with a series of obligations related to the programme.
This includes submitting additional drug-specific information for the FDA’s review and approval, relabelling the drugs to be consistent with that approved by the regulator, and ensuring that the drugs have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.
In addition, the AHCA must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues.
Robert Califf, FDA commissioner, said the agency is “committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals”.
He continued: “These proposals must demonstrate the programmes would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
Despite its potential cost-saving benefit, the programme has faced backlash from the pharmaceutical industry.
Innovative Medicines Canada, which represents major drugmakers, has said it is “deeply concerned” with the FDA’s decision and “remains committed” to working with Health Canada and other stakeholders to “safeguard drug supply” for Canadian patients.
David Renwick, interim president of Innovative Medicines Canada, said: “Canada simply can’t supply drugs to Florida or any other US states without significantly increasing the risk and severity of drug shortages nationwide.
“The US market is nearly ten times bigger than Canada’s, and allowing drugs that were intended for Canadians to be exported to the US would harm Canadian patients and disrupt our healthcare system.”