Out for 2024? Paying full price for prescription medications. In? Importing drugs from Canada.
The new year began with federal health officials authorizing Florida’s plan to bring in certain medications from Canada, where they’re often sold at significantly lower prices than in the US.
States that have long pushed the FDA to allow drug importation from Canada touted the move as a major step forward in their efforts to lower prescription drug spending and rein in healthcare costs.
But while the idea of importing drugs from Canada is new for states, some businesses have been using existing drug import pathways to help consumers save money on certain high-cost medications.
Dave Berkemeier, president and owner of Onsite Health Solutions, told Healthcare Brew that the employer health and wellness provider works with RxProtect—a partner group and one of its recommended vendors—to help self-funded employers source lower-cost drugs from US and Canadian pharmacies.
Specifically, RxProtect works with drug wholesaler McKesson, which picks up pharmaceuticals and ships them to a pharmacy partner in Canada. After that, the drugs head to patient doorsteps. Berkemeier noted that RxProtect is a “patient advocacy program” that “provides customer support and logistics in relation to the importation process.”
“Importation is strictly a relationship between the patient and the fulfilling pharmacy in Canada,” he said.
Federal law currently allows drug wholesalers like McKesson and pharmacists to import prescription drugs from Canada (which has a universal publicly funded health system) if they meet certain safety standards and save consumers money, according to KFF.
A 2020 Government Accountability Office report found that brand-name prescription drugs sold in the US generally cost at least twice as much as the same medications sold in Australia, Canada, and France.
“We’ve seen tremendous savings on an employer with about 1,000 employees. Our data shows us [...] it’s about $500,000 in opportunity costs for the exact same meds,” Berkemeier said.
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RxProtect also has a non-import program that allows employers to access some prescription drugs at a savings of about 40%, he said.
States eye Canadian drug imports
The Biden administration’s early January approval of Florida’s drug importation plan put it one step closer to becoming the first state to bring in certain prescription drugs from Canada under a Federal Food, Drug, and Cosmetic Act pathway.
And other states—including Texas, Colorado, New Hampshire, and New Mexico—want in, too.
The FDA authorized the Florida Agency for Health Care Administration’s program, which allows states and tribes to import prescription drugs if the proposal would substantially reduce costs to US consumers without “adding risk of exposure to unsafe of ineffective drugs.”
The approval came just months after the FDA raised concerns in an August letter that Florida’s plan had failed to demonstrate how it would save consumers money and secure the drug supply chain.
Before Florida can begin importing drugs, the Agency for Health Care Administration must submit additional drug-related information for FDA review and approval, ensure the medications have been tested for authenticity and comply with FDA standards, and properly relabel drugs.
The state must also report quarterly to the FDA on the imported drugs (including information about the quantity of active ingredient and the dosage form, among several other things), cost savings, and potential safety or quality issues. To import drugs, Florida must also fulfill certain obligations, such as establishing supply chain integrity, reporting on adverse events, and complying with recall procedures.
The authorization will be valid for two years starting from the date the FDA is notified of the first shipment of drugs to be imported via the program.