By D. Wayne Taylor
This article appears in Investor’s Business Daily.
Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA), recently promised to ensure that all U.S. medicines are safe and effective. But he won’t be able to do so if Congress proceeds with a misguided plan to allow patients to import prescription drugs.
Americans rely on the FDA’s ability to track and certify all medications, which currently never leave a closely monitored supply chain. Unfortunately, other countries don’t vigilantly monitor their medications. Their lax standards result in an unreliable supply of medicines — including fake drugs — that don’t work as patients and doctors expect.
In Nigeria, most of the drug supply originates from India and China. A 2011 World Health Organization survey found 64% of anti-malarial medicine in the country to be fake.
Nigeria isn’t an outlier. In many African nations, the share of fake medicines tops 30% of the total drug supply. In Angola, officials discovered that 1.4 million antimalarial drugs shipped from China were counterfeit. These counterfeit drugs kill patients by the tens of thousands. Compromised antimalarial drugs lead to the deaths of more than 120,000 African children every year. That’s roughly the equivalent of a jumbo jet crashing every day.
Doctors in the poorest countries are suspicious of the quality of their drug supply. But still, they deliver these drugs to patients, since they have no other option.
Imagine an American oncologist worrying about the quality or safety of a medicine she was about to deliver to a patient!
The death toll from fake medicines in Africa is staggering, but the long-term impact of ineffective medications may be worse. Adulterated drugs that contain only small amounts of active ingredients not only fail to treat the sick, but can also expose bacteria to weak antibiotics. This exposure creates drug-resistant strains of disease.
Pandemics know no borders. A drug-resistant malaria superbug — which was detected in Africa for the first time in February — could lead to a global outbreak and kill millions of people per year. Bill Gates recently warned that a global pandemic could arise within the next ten to fifteen years and kill over 30 million people.
Right now, the United States has a closely monitored and closed distribution system to keep fake and adulterated medicines out. However, Congress is considering a drug importation bill that would dismantle these protections.
The proposed law requires foreign drug distributors to certify compliance with certain safety protocols. But foreign pharmacies, for example, do not need to verify the accuracy of their submitted reports. Even if FDA regulators suspect a foreign pharmacy is lying, the U.S. government legally cannot enforce compliance. In short, the government must blindly trust foreign drug distributors.
That’s why four former FDA commissioners from the Obama and Bush administrations oppose the current bill. They recently wrote an open letter warning that “obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.”
If the bill passes, counterfeiters could exploit these weaknesses to “transship” drugs from unreliable developing markets, through supposedly safe countries, and then on to the United States.
Criminals have already used this tactic to prey on Americans and sell them fake drugs. In 2015, one Washington man, Jae Seon Yoon, imported and sold drug paraphernalia and thousands of fake pills that were made in China but shipped through Canada and labeled with Canadian logos.
Fake drugs are killing tens of thousands of people in African nations that lack the resources and systems to rigorously monitor imported medicines.
Americans are fortunate to have the FDA to protect them from unreliable imports. It’d be a travesty for Congress to cripple the FDA and weaken the time-tested safety measures that have kept Americans safe.
D. Wayne Taylor, Ph.D., is the executive director of The Cameron Institute, an alternative, nonprofit, public policy think tank specializing in the independent study of health, social and economic issues both in Canada and the world.