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.