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Drug Importation Opens Doors to Counterfeit, Compromised Drugs

Institute for Policy Innovation

Health and Human Services Secretary Alex Azar announced the Trump administration will reverse a decades-long policy and create a way for Americans to import prescription drugs from Canada.

Azar says that by moving forward on reimportation, the administration is putting Americans patients first. But IPI experts agree that the practice has been illegal chiefly because it puts Americans in harm’s way. Importantly, drug manufacturers cannot guarantee the safety of prescription drugs reimported to the United States.

“It is virtually impossible for brand name manufacturers to monitor their products after they leave the U.S.,” wrote IPI resident scholar Dr. Merrill Matthews in the Legislators Guide to Prescription Drug Importation. “It can even be difficult trying to monitor the drugs in this country once they go into the secondary market, where they may pass through a number of middlemen before finally landing up in a pharmacy.”

The U.S. often restricts the trade of dangerous products that can harm humans, animals and the environment, Matthews explains. “Prescription drugs are not like many other consumer products: they are inherently dangerous. That is why it requires a prescription to purchase them.”

“The importation issue is not about a small number of patients crossing the border, going to a reputable pharmacy with a licensed pharmacist and buying a small amount of a prescription drug for personal use,” he said. “It is about millions of consumers trusting drug vendors they have never seen; having no idea if their facilities are safe and located where they claim to be; and, knowing whether the drugs are counterfeit, diluted, mishandled, mislabeled or unapproved.”

For example, a 2017 amendment to PDUFA proposed by Sen. Bernie Sanders would have allowed for the importation of drugs from Canada and consequently opened the floodgates for criminals involved in counterfeiting drugs to have a legitimate opening to the U.S. market. “The FDA struggles now to meet its obligations to ensure the safety and efficacy of prescription drugs being manufactured and sold to Americans without having to also become the guarantor of Canada’s pharmacies,” said Matthews.

Bottom line, says Matthews, if reimportation becomes widespread, some Americans will be harmed — it is only a matter of time. “And then the question will be who will be held responsible?”

Matthews is also the author of Prescription Drug Importation: Unsafe, Unnecessary and Unwise, Prescription Drug Importation of Prescription Drugs: A Bad Idea; and Five Reasons to Oppose Reimportation.

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