U.S. set to allow Florida to buy drugs from Canada, officials here ‘deeply concerned’

On Friday, the FDA released a decision saying Florida could “import certain prescription drugs from Canada if (it) will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety.”

“It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma,” said Florida Governor Ron DeSantis.

Other jurisdictions in the U.S. could soon follow Florida’s lead because the FDA has created an approval pathway that will be open to other “states and Indian tribes,”  according to a statement released by the department.

The U.S. pays by far the highest price for patented medicines among members of the Organization for Economic Co-operation and Development, with essentially no government limits on what companies can charge. While Canada pays far less by comparison, its prices still ranked third highest as of 2021.

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

Authorities and experts here have long expressed fears that Canadian patients’ access to lifesaving medications could be jeopardized if Canada’s drug supply can be sold in the U.S.

Canada makes and exports drugs, but most prescription medicine is imported from other countries and is meant to supply Canadians with drugs, not other markets.

“We’ve always said that the U.S. needs to look at their own system and come up with regulations that make sense in their context,” said Joelle Walker, the Canadian Pharmacists Association’s vice president of public and professional affairs. “And not look to Canada to be their pharmacy.”

In an email, the FDA said that other states in addition to Florida had submitted proposals to import drugs from Canada.

Innovative Medicines Canada, which represents Canada’s pharmaceutical industry, said they were “deeply concerned” about the FDA ruling.

“Canada simply can’t supply drugs to Florida, or any other U.S. states, without significantly increasing the risk and severity of drug shortages nationwide,” said David Renwick, interim president of Innovative Medicines Canada, in an online statement. “The U.S. market is nearly 10 times bigger than Canada’s, and allowing drugs that were intended for Canadians to be exported to the U.S. would harm Canadian patients and disrupt our health-care system.”

But the federal Minister of Health insisted Friday afternoon Canadians’ access to medications will not be harmed by the FDA’s decision.

“Canada has strong regulations in place to protect supply,” Mark Holland said in a statement. “Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”

In 2020, the Canadian government placed export restrictions on prescription drugs in response to a proposal from then-U.S. president Donald Trump that would have permitted states to import Canadian pharmaceuticals, fearing such a step would create or worsen drug shortages at home.

Then Canadian Health Minister Patty Hajdu signed the order, which prohibits exporting drugs that could lead to a shortage here at home.

Health Canada sent a bulletin on Friday reminding pharmaceutical manufacturers and distributors, as well as pharmacists and others in the sector, of the existing safeguards.

The department won’t hesitate to address non-compliance, spokesperson André Gagnon said in a statement.

Rule breaking could be met with a public advisory or more serious sanctions, including revoking or suspending licences, the statement said.

Walker said she is confident that the regulation will help restrict the mass export of drugs to the U.S., but she is concerned that the FDA’s decision will encourage some people to find loopholes.

”I think what’s concerning is that the FDA has approved a proposal knowing that Canada has put in place restrictions,” said Walker. “And I think what we’re concerned about is that it could encourage people to circumvent some of the regulations that are in place here in Canada.”

Walker, though, said “I do want to reassure Canadians that we’re not concerned about any immediate threat. That they shouldn’t rush to their pharmacy to refill their prescriptions today.”

But given Canada’s existing drug shortages, some experts fear the worst.

“What it can do, if it even satisfies a fraction of the American demand for drugs, is plunge Canada into massive shortages,” said University of Ottawa professor Amir Attaran.

The move from the FDA was prompted by U.S. President Biden’s Executive Order on Promoting Competition in the American Economy, which emphasized lowering the cost of drugs in the U.S. by stimulating competition, not unlike the Canadian government’s move to entice a foreign grocery chain to the country to help lower food costs. 

But there are still a number of factors that a U.S. state would have to meet to get FDA approval.

Florida’s Agency for Health Care Administration will have to submit drug-specific information to the FDA for review and approval, according to the FDA, and ensure that the drugs have been tested for “authenticity and compliance” with the comparable FDA approved drug. The imported drugs must also be re-labeled to meet FDA standards.

“There are a bunch of things that Florida would have to do to get (the FDA’s) final approval,” said Walker. “And some of them are pretty cost prohibitive. So it may not make a lot of financial sense for them in the end.”

Florida has claimed it can save an estimated US$150-million dollars because the prescription medicines it wants to import are cheaper than their American counterparts. Numerous other American states have been hoping to do the same in an effort to save millions of dollars on their health-care budgets.

Attaran said while it is true that Canadian patented drug prices generally cost much less than American, “it’s unclear how much of that margin would be eaten up by middlemen.”

“It makes you wonder why Florida thinks this is worth doing, except for the fact that it’s an election year,” Attaran told the Star.

“I just don’t see how that’s going to provide a meaningful release from the reality that American drugs are overpriced.”

The FDA’s decision has also angered the U.S. pharmaceutical industry.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” said the PhRMA in a statement on Friday, claiming the decision of “unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health.”

The organization said it is “considering all options for preventing this policy from harming patients.”