Canada issued a warning Monday that it stands ready to defend its prescription drug supply from US importation plans—and also said the plans wouldn’t work for the US, anyway. “Bulk importation will not provide an effective solution to the problem of high drug prices in the US,” Health Canada said in a statement.
The defensive stance comes just days after the US Food and Drug Administration granted Florida authorization to directly import cheaper prescription drugs from Canada in an effort to help drag down America’s uniquely stratospheric drug pricing. Florida is the first state to win such an authorization, and Florida Governor Ron DeSantis celebrated it, claiming the drug imports will save the state “up to $180 million in the first year alone.” There are caveats, though. Before Florida can import any drugs, it must complete several obligations, including submitting to the FDA additional drug-specific information, testing the drugs for authenticity and FDA compliance, and relabeling them in accordance with FDA labeling.
The FDA authorized the importation program in accordance with section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The move stems from President Biden’s “Executive Order on Promoting Competition in the American Economy,” which directed the FDA to help develop such programs.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert Califf said in the agency’s authorization announcement. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
Proponents of the program in the US say that importing cheaper drugs from abroad could help lower US drug prices by offering more competition on the market. Canada, like other countries, has lower drug prices than the US, partly because the country’s national health system negotiates prices for prescription drugs. The US government only began negotiating prices last year—and is currently being sued by several pharmaceutical companies over the move.
But Canada, which has a population around nine times smaller than the US, has been staunchly opposed to the US importing its drugs. It has repeatedly said that diverting medicines to the US could lead to drug shortages in Canada, make existing shortages worse, and/or cause price spikes.
In its statement Monday, Canada said it was mounting defenses against such possibilities in light of the FDA’s authorization. “The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need,” it said.
“Health Canada is actively monitoring the Canadian drug supply,” it continued and cited recent Canadian regulations that prevent the distribution of drugs outside the country if it could cause or worsen a drug shortage within Canada. “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.”
Drug makers in the US also intend to fight the plans. Stephen Ubl, CEO of the powerful trade group PhRMA—Pharmaceutical Research and Manufacturers of America—said in a statement that the group is “deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan” and claimed importation “poses a serious danger to public health.” Ubl concluded that “PhRMA is considering all options for preventing this policy from harming patients.”