Drug Importation: High Risk, Low Reward

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Recently, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) unveiled the Safe Importation Action Plan, a proposal to allow drugs to come into the U.S. from abroad with the goal of delivering cost savings for American consumers.

It’s tempting to think that legalizing drug importation would immediately give U.S. consumers access to medicines at the prices available in other developed countries. In reality, however, the Safe Importation Action Plan would expose American consumers to significant health risks while achieving meager cost reductions, if any at all.

Drug importation would make it easier that counterfeit drugs, which constitute a booming global enterprise, to infiltrate the U.S. pharmaceutical system and put patients at risk. Currently, the U.S.’s relatively closed system of prescription drug manufacturers, suppliers, and distributors protects the American people from unsafe or contaminated products.

By contrast, many foreign countries lack basic quality control and enforcement mechanisms. The World Health Organization estimates that “1 in 10 medical products in low- and middle-income countries is substandard or falsified.” And advances in counterfeiting technology have made it nearly impossible for consumers or even health care providers to spot fake drugs.

In 2003, the last time drug importation schemes were seriously debated in Congress, then-FDA Commissioner Mark McClellan warned that drug importation “creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our nation’s drug supply.”

Even drugs marketed from other advanced countries often originate from countries that lack proper safety regulations, allowing drugs to be stored at unsafe temperatures, formulated with unsafe ingredients, or manufactured in non-sterile conditions. An estimated 85 percent of medications sold from “Canadian” online pharmacies, for example, are not actually from Canada.

In 2011, Betty Hunter, an Arizona resident suffering from lung cancer, went to her oncology clinic to receive a cancer medication called Avastin. She quickly developed chills, vomiting, cramping, and a spike in her fever. It was later discovered that Hunter’s doctor had obtained the drug from a Canadian supplier, which had purchased the drug from a Turkish manufacturer. Analysis revealed that the fake medication not only lacked the active pharmaceutical ingredient in Avastin, but contained tap water and mold.

Opening the door to counterfeit drugs from abroad would not only endanger the health of those who took the drugs but also anyone taking a similar drug. Just a few unsafe capsules could trigger massive nationwide recalls, creating shortages and discontinuities of care for millions of patients. In 1982, for example, 31 million bottles of Tylenol were removed from circulation after seven people died from pills laced with potassium cyanide. Imagine the effects of a similar recall of insulin or other life-saving medicine triggered by a tainted shipment of foreign products.

And foreign countries like Canada have made it clear that Americans shouldn’t expect them to monitor the safety of drugs being shipped to the U.S. “There’s no question that a drug importation scheme will increase the flow of counterfeits in the U.S. supply chain,” wrote former FDA Commissioner Scott Gottlieb in 2016. Constructing an oversight apparatus capable of closely monitoring drug imports from abroad would be so costly as to erase any economic benefits from importation.

Even if we ignore safety concerns over poorly regulated imported drugs, the cost savings from importation would likely be negligible. When the nonpartisan Congressional Budget Office (CBO) examined a similar proposal in 2005, it found that “permitting the importation of foreign-distributed prescription drugs would produce at most a modest reduction in prescription drug spending in the United States” -- on the order of 1 percent of total spending.

Drug importation may be a popular political talking point, but it’s not a viable solution for American consumers struggling to afford their medications. Instead of delivering drugs at deeply discounted prices, drug importation would jeopardize the safety of the U.S. pharmaceutical system, expose consumers to dangerous counterfeit products, and leave prices at the pharmacy virtually unchanged.

American patients deserve better.

Liam Sigaud works on economic policy and research for the American Consumer Institute, a nonprofit educational and research organization. For more information about the Institute, visit www.TheAmericanConsumer.Org.

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