Overview
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, is the wrong answer.
The United States is the gold standard when it comes to regulating the safety of our medicine supply. Importing medicines from countries that do not have our same strong standards could taint our medicine supply. Without proper Food and Drug Administration oversight and enforcement of laws designed to protect patient safety—which importation schemes would undermine—there is increased potential for counterfeit or adulterated products to infiltrate the U.S. pharmaceutical supply chain, with life-threatening consequences.
1 IN 10
mEDICINES
worldwide are counterfeit
95%
of internet drug outlets
have been found to be operating out of compliance with federal and state pharmacy laws and practice standards
+48,000
number of packages
containing counterfeit medicines that were seized by Interpol during one week in March of 2020
The History of Drug Importation
The History 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 this certification. In fact, despite claims to the contrary, the 2020 certification and implementing rule failed to meet either prong required for this importation program. Instead, the final rule punted the demonstration of safety and cost savings to state governments, even though the statute requires the Secretary to make the certification.
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.
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 that 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 91 percent 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 Russian roulette with patients’ lives.
