Earlier this year, the Trump Administration released a final rule focused on allowing states and others to establish programs to import prescription drugs from Canada.
Under the final rule, states, tribes, pharmacists, and wholesalers can submit plans to the United States Food and Drug Administration (FDA) to import medications from Canada. The plans must show that they would save patients money and the sponsors of the plan must also show that the medications being brought in do not pose any threats to patient safety.
A separate guidance outlined requirements by the FDA to import biological products. Under that guidance, the products must be FDA-approved and be manufactured and approved for sale in other countries.
Congress has allowed for drug importation since 2000, but only if it is certified as safe by the Secretary of the Department of Health and Human Services (HHS). According to HHS Secretary Alex Azar, the final rule “poses no additional risk to the public’s health and safety and will result in a significant reduction in the cost of covered products to the American consumer.” This permission allows the final rule to move forward
Interestingly, the final rule includes a severability clause that indicates that the provisions of the final rule are “not separate and are not severable from one another” and therefore, if any provision of the entire rule is “stayed or determined to be invalid or unenforceable,” the rest of the rule will also fail. While it does make sense to include this clause based on the safety measures that must be taken when it comes to prescription drugs, the clause increases the risk that the entire program will fall, based on the range and complexity of the final rule.
Insulin Not Included
While insulin is not included in the list of drugs covered by the rule, the Trump administration continues to try to lower all drug prices and has issued a request for proposals from private companies on how insulin could be safely brought in from other countries and made available to patients at a lower cost than products already here. The request for proposals specified that the insulin would have to have once been in the United States and sent to other nations, before being brought back for sale.
Individual Consumers
As the final rule is written, individuals will not be able to import drugs on their own, but would have to rely on programs run by individual states. However, Trump administration officials are interested in learning more about how to better allow individual consumers to benefit from importation and issued a second request for proposals to set up a system that would allow American consumers to import drugs through their local pharmacies.
What’s Next?
If the final rule takes place, individual states will be able to implement their own importation policies, and several states have already indicated their interest in doing so, including Florida, whose legislature approved two importation programs in 2019. While Americans have long been purchasing drugs from Canada for personal use despite it being illegal, the FDA has generally permitted purchases for individual use. It will be interesting to see if that policy shifts with the new importation rule, or if it will continue has it has for decades.