“Drugs from Canada” is a policy that won’t work. And a political soundbite that won’t die.
As H.L. Mencken presciently said, “For every complex problem there is an answer that is clear, simple and wrong.”
That’s exceedingly true in the debate over whether states should be allowed to import drugs from Canada en masse. On Friday, the Food and Drug Administration granted conditional approval for a Florida plan to do just that.
But let’s set aside the rhetoric and look at the facts:
First, how much would all the added risk to the safety and effectiveness of medicines from importation save US consumers? Hardly anything.
The Congressional Budget Office ran the numbers and found that importing drugs would cut costs by a paltry 0.01%.
If that sounds surprising, it’s probably because importation advocates exaggerate the savings patients can expect.
Outside of a few specialty drugs, most generic drugs approved by the FDA for sale in the United States cost about the same here (or less) as they do in Canada — and about 90% of the drugs prescribed in America are generics.
Second, the population math is upside down.
According to Mary Durette, a spokeswoman for Health Canada, Canada’s version of the FDA, “Canada’s drug supply is too small to meet the demands of both American and Canadian consumers.”
Florida has a population of almost 22 million. The strain on the Canadian medicine supply would likely lead to shortages and increased costs for Canadian patients.
If Canada filled 10% of US prescriptions, its own drug supply would run out in less than eight months.
In 2019, I testified before the Florida legislature on lawmakers’ desire to import Canadian drugs.
“Has anyone discussed this idea with Health Canada?” I asked.
The answer? “No.” Of course not.
Call me the Cassandra of Canadian drug importation.
Indeed, Canada is already facing a serious problem with drug shortages.
There are close to 1,800 drugs in short supply, per Canada’s health ministry.
And in a recent survey of more than 1,700 pharmacists, 79% said they believed the frequency of drug shortages had “greatly increased” over the past three to five years.
Meanwhile, the Florida Plan would undoubtedly send many Americans to existing scam “drugs from Canada” websites.
One FDA operation found 85% of “Canadian” drugs actually originated in 27 different countries.
And more than a third of those drugs were potentially counterfeit.
“Drugs from Canada” does not always mean “the same medicines Canadians get.”
Canadian regulators have warned Americans that importation could be risky.
One official at Health Canada said the regulator “does not assure that products being sold to US citizens are safe, effective and of high quality and does not intend to do so in the future.”
Relying on caveat emptor makes for bad health-care policy.
It’s also crucial to recognize that Health Canada and the FDA make regulatory decisions independent of each other — and the approval processes are not identical.
Imported drugs would not receive the same kind of FDA scrutiny and certification for safety, quality and effectiveness as American-made drugs.
Should prisoners and people on Medicare and Medicaid, who’d be given the drugs imported by states like Florida, be Guiana pigs for this ill-considered scheme?
Headlines notwithstanding, the Florida plan’s approval is conditioned on several difficult next steps.
Per the FDA, “Before drugs can be imported, Florida’s Agency for Health Care Administration must:
- Submit additional drug-specific information for the FDA’s review and approval.
- Ensure the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.
- Relabel the drugs to be consistent with the FDA-approved labeling.
These requirements are not easy tasks to accomplish and aren’t foregone conclusions.
As for the political ramifications, the Florida plan will only add to the already existing confusion and general bloviation over ways to address better access to medicines.
Alas, there are no simple answers.
But drug importation is no longer a pipe dream. It’s now a pipe bomb.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.