After declining similar demands for years, the U.S. Food and Drug Administration (FDA) has, for the first time ever, given permission to import a number of drug classes from Canada for Florida’s Medicare and other recipients.
While Florida seems to think this would save money, pillaging drugs from Canada is a band-aid approach to America’s problem and will cause Canadians much suffering as drug shortages increase north of the border.
One reason that the FDA has denied such demands in the past is a lack of resources necessary to oversee a large-scale importation program and an inability to certify that drugs being imported or trans-shipped were safe and of the same quality as those sold directly into the United States.
The FDA’s permission is conditional on Florida’s Agency for Health Care Administration complying with several costly obligations. These include submitting additional drug-specific information for FDA’s review and approval, relabelling drugs to be consistent with FDA-approved labels and ensuring that drugs are tested for authenticity and compliance with FDA-approved specifications and standards. Florida must also submit quarterly reports to the FDA providing information on the imported drugs, cost savings and any potential safety and quality issues.
This additional work will not be free or easy. Canada does not inspect drugs leaving its borders. This gap in inspections, especially for transhipments, opens the door for less than scrupulous people and organizations to substitute fake or adulterated drugs.
The FDA’s decision sent Canadian media into a frenzy of concern about additional drug shortages. About 1,800 drugs are already on Canada’s watch lists for actual or potential shortages.
Federal health minister Mark Holland said the Canadian government would not allow drugs to be sent to Florida and that “we will not allow the U.S. at all to use Canada as a means of fixing” its challenges. But Canadian governments don’t control the supply of prescription drugs in Canada, even though they pay for a proportion of them through numerous public drug plans.
Florida has hired a U.S. wholesaler that has a contract with a Canadian wholesaler (Methapharm) to acquire drugs intended for Canada and ship them to Florida, instead of putting them into the Canadian system. In theory, Methapharm will make money from the difference between Canadian wholesalers’ price and the price the U.S. wholesaler will pay. Large-scale diversion of just some of Canada’s drug supply would definitely lead to shortages that will not be replaced by manufacturers.
Drug manufacturers allot production to countries by assessing the number of patients who will take the medicine each year. They are highly unlikely to allocate more drugs to Canada from other countries or to increase production for Canada when they know that the medicines will be redistributed to the United States at prices that undercut their American business.
We’re staring at a slippery slope. Florida is not the only state that wants to import drugs from Canada; six other states have passed bills and a further six have pending legislation to import medicines from Canada.
American politicians have wanted to import drugs from Canada for years. In 2017, Sen. Bernie Sanders (I-Vt.) proposed the Affordable and Safe Prescription Drug Importation Act to allow American wholesalers, pharmacies and individuals to import qualifying prescription drugs from “licensed” Canadian sellers. And Republican Donald Trump mused about importing drugs from Canada in his prior presidential campaigns.
American politicians may be trying to apply pressure on the federal government to introduce controls for drug pricing or to persuade pharmaceutical companies to make their products more affordable. However, a more cynical perspective is that it’s merely a political strategy to convince voters that they are working hard for the average Joe. Either way, Canada’s drug supply is not a real solution to America’s high prices.
Canada’s system for controlling prices within its public drug plans is far from perfect. It presents serious challenges for both patients and health care providers, but it does provide lower prices. U.S. politicians should directly address the issue of how to achieve affordable drug access in their country and not plunder another nation’s prescription drug supply in an attempt to solve their problem.
It’s time for Canada’s political leaders to take firm action to protect our fragile drug supply and U.S. politicians to accept responsibility and not raise false hopes of a foreign windfall.
