Move to allow US to import Canadian drugs raises fears of shortages

Laura Osman, The Canadian Press

Posted on Friday, January 5, 2024 3:40 pm EST

Last updated Friday, January 5, 2024 3:45 pm EST

OTTAWA – Health Canada has reminded the pharmaceutical industry of export rules designed to prevent drug shortages after a major change in U.S. policy on purchasing prescription drugs from north of the border sparked fears of a supply shortage .

The U.S. Food and Drug Administration on Friday announced plans to allow Florida to import millions of dollars in pharmaceuticals from Canadian wholesalers as a way to avoid the high cost of drugs in that country.

The decision is not great news for Canada, which has increasingly faced severe drug shortages in recent years, said Joelle Walker, vice-president of public affairs at the Canadian Pharmacists Association.

Florida’s population is more than half the population of all of Canada. And beyond Florida, other American states are considering similar requests to the FDA to address drug costs.

“Considering Canada as your pharmacy is simply not practical. “We can’t do it, it’s not possible,” Walker said.

In recent years, Canada has run out of a variety of medications, from childhood fever medications to certain cancer medications and, most recently, the popular drug Ozempic for weight loss and diabetes management.

Florida’s proposal includes asthma medications; chronic obstructive pulmonary disease or COPD; diabetes; HIV and AIDS; and mental illnesses.

But the threat is not immediate, Walker said, and people should not rush to renew their prescriptions.

Florida still has more work to do to prove that imports would actually save Americans money without sacrificing public safety, as well as test the drugs to make sure they are authentic and relabel them to meet American standards.

“That in itself could be quite cost-prohibitive and we hope it will be a disincentive for Florida to proceed,” Walker said.

If a manufacturer wants to export drugs to the United States, it would need approval from Health Canada, which the federal regulator would presumably deny if it feared a shortage.

Health Canada sent out a bulletin on Friday suggesting it intends to stick with that line.

The message reminded pharmaceutical manufacturers and distributors, as well as pharmacists and others in the sector, of the safeguards in place against shortages.

Canadian regulations prohibit the distribution outside the country of certain locally produced pharmaceutical products if there are “reasonable grounds to believe that doing so could cause or worsen a drug shortage,” the bulletin said.

“Drugs intended for the Canadian market may continue to be sold for consumption outside Canada if the sale does not cause or exacerbate a drug shortage in Canada.”

The United States pays by far the highest price for patented drugs among members of the Organization for Economic Cooperation and Development, and there are virtually no government limits on what companies can charge. While Canada pays much less in comparison, its prices still ranked third highest in 2021.

Americans have long been able to fill prescriptions at Canadian pharmacies, but the recently announced policy change affects mass imports.

The FDA’s decision comes after years of successful lobbying against the idea by the pharmaceutical industry, which said imports would expose American patients to risks from counterfeit or adulterated drugs. The FDA also previously warned of the difficulties of ensuring the safety of drugs coming from outside the US.

The politics surrounding the issue have changed in recent years, with both Democrats and Republicans doubling down on the import approach.

The drugs would be only for certain people, including foster children, inmates, certain geriatric patients and, eventually, Medicaid recipients.

This report by The Canadian Press was first published Jan. 5, 2024.

– With files from The Associated Press

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