Medicine Safety

Drug Importation

Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious risk to public health.

The U.S. Food and Drug Administration (FDA) is the gold standard when it comes to reviewing and approving drugs. Medicines that enter the United States through importation will not be subject to these same strong standards and, as a result, counterfeit, substandard or diverted, repackaged and adulterated drugs could be introduced into our secure drug supply chain. Importation schemes could have life-threatening consequences.

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Why Drug Importation is Bad for Patients

Importation schemes have been proposed at various times as an approach to reducing drug costs. However, these schemes fail to acknowledge the resources required to ensure the safety and efficacy of any drugs being imported from or passing through other countries into the United States would outweigh any potential savings. They also ignore that generics comprise more than 90% of the U.S. market today and are widely available lower-cost alternatives for patients. Not to mention, the exponentially higher risk of counterfeit, adulterated and substandard products entering the United States and harming patients would be playing roulette with patients’ lives.

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Two Decades of Drug Importation

In 2003, the Medicare Modernization Act gave the Secretary of Health and Human Services limited power to allow the importation of some drugs from Canada, but only if the Secretary could certify the imports would both 1) pose no additional risk to public health and safety, and 2) generate cost-savings for American consumers. To date, not a single Secretary, from Democratic and Republican administrations, has been able to make these certifications. Even in 2020, despite claims to the contrary, the Secretary was no more able to certify than his predecessors and questionably circumvented the statute by punting the responsibility to state governments.

Over the years, a handful of states have piloted drug importation programs as a way to provide access to drugs from outside the United States, but there has yet to be a successful program. For example, six states tried a contracted importation program with a Canadian operator of online pharmacies that cost $1 million to implement. Four years later, the program was deemed a failure and terminated.