By Peter J. Pitts
Former FDA Associate Commissioner and Member of the United States Senior Executive Service, President of the Center for Medicine in the Public Interest and Visiting Professor at the Faculty of Medicine of the University of Paris InsideSources.com
Most Americans take the safety of their prescription drugs for granted. But if the FDA allows states to import drugs from Canada, that could change, as the risks of some imported drugs far outweigh the benefits.
The lure of importing drugs is understandable. Patients hear about people in other countries paying less for the same drugs, so they naturally want to take advantage of what looks like a bargain. But what some see as a “cure” for expensive drugs could be worse than the disease.
Counterfeit medicines cause more than one million deaths a year, according to the World Health Organization (WHO). It’s bad enough that a large group of doctors banded together in 2019 to declare the rise of “falsified and substandard medicines”. a “public health emergency”, which kills 250,000 children a year.
And, unfortunately, the danger is growing. A Pfizer study identified 29 fake medicines in 75 countries in 2008. In 2018, there were 95 fake medicines in 113 countries. According to the WHO, one in 10 medicines sold in developing countries are counterfeit or substandard, leading to tens of thousands of unnecessary deaths each year.
But the problem is not just in the developing world. In 2018, as part of a week-long anti-counterfeiting operation, Canadian authorities inspected nearly 3,600 packages and found that 87% contained counterfeit or unlicensed health products.
American patients are protected for now, but we shouldn’t think of ourselves as immune. It is no coincidence that the Drug Supply Chain Security Act, which ensures the safety of drugs prescribed here, was enacted shortly after a counterfeit version of the cancer drug Avastin – a drug devoid of the active ingredient needed to fight tumors – ended up in the hands of American patients.
Such a scenario is unacceptable. Yet if we give the green light to drug importation, we only make it more likely. We simply cannot guarantee the safety of drugs produced outside of the United States. Even many of those that come from Canada were not made there. Canadian regulators have even warned against the practice – saying they “do not guarantee that products sold to US citizens are safe…and have no intention of doing so in the future”.
How much would all this added risk save US consumers? Virtually nothing. The Congressional Budget Office analyzed the numbers and found that importing drugs would reduce costs by a measly 0.01%. Even if the practice were perfectly safe, which it is not, it wouldn’t be worth it.
Apart from a few specialty drugs, most generic drugs approved by the Food and Drug Administration for sale in the United States cost about the same price here as in Canada – and about 90% of prescription drugs in the United States are generics.
Import advocates promise ‘safe, cheaper drugs from Canada,’ to quote the Biden administration, but the ‘cheaper’ part has been grossly oversold, and the ‘safe’ part is far from the truth. . With so many lives at stake, we cannot afford to play Prescription Roulette.