Moving forward with prescription drug importation

November 14, 2019

Under the comprehensive prescription drug reform package Governor Mills signed into law in June, Maine will move forward with a wholesale drug importation program, pending approval from the U.S. Department of Health and Human Services.

The program was created under a bill sponsored by Senate President Troy Jackson, D-Allagash -LD 1272, "An Act To Increase Access to Low-cost Prescription Drugs." Maine's bill was modeled after a Vermont law that passed last year.

On July 31, the Trump administration released the Safe Importation Action Plan, which indicated that the federal government would release rules to provide an official pathway for states to apply to import prescription drugs. Governor Mills welcomed this development.  Maine, along with the other three states where drug importation legislation has passed, is awaiting details. However, the federal government has not set a timeline for the release of the proposed guidance for states.

In the absence of guidance from the federal government, the Maine Department of Health and Human Services (DHHS) has released a proposed rule to authorize application for federal approval of a drug importation program as soon as is practicable after federal rules are finalized. Our proposed rule also creates a way for the public and other interested stakeholders to provide feedback about the structure and operation of the program. For example, we will gather ideas on which drugs should be imported, how, and best practices to promote safety and savings. We are now accepting public comment on the rule through December 12, 2019.

DHHS looks forward to designing a program that allows Maine people better access to safe and affordable prescription drugs. As Governor Mills said in July, "For far too long, we have had to fight the federal government tooth and nail on the issue of safe importation of quality medication – and often unsuccessfully so..." The prospect of prescription drug importation in the U.S. dates to 2003, when Congress directed the secretary of U.S. HHS to approve prescription drug importation programs that provided significant savings to consumers with no additional safety risks. No HHS secretary has since used that authority and no means was created for states or other entities to apply for approval to import prescription drugs. In Maine, a 2013 legislative effort to allow the importation of prescription drugs was blocked by a federal judge who ruled that federal law, which currently strictly limits drug importation, preempts state law.

With Maine DHHS's proposal, we stand ready to review, shape and take advantage of the Trump administration's expected rule on drug importation.