By: Andrew Silverio, Esq.

With a few lines tucked into a July 09, 2021 executive order, the Biden administration clarified what had recently become a murky outlook on the future of fully legal foreign drug importation programs.

Initially, a July 2020 Trump executive order directed HHS to develop regulations under which states, Indian tribes, “and in certain future circumstances pharmacists and wholesalers” could develop and submit foreign drug importation programs for approval.  The regulations in question appeared on September 24, 2020, and states quickly began developing and submitting plans for approval.  However, to date, none have been approved.

For the states, tribes, and other stakeholders invested in the success of these programs, the new Biden administration’s first public position on these rules and programs was not encouraging.  A pharmaceutical industry organization filed a lawsuit challenging the program, and in defending it, the Biden HHS cast doubt on whether programs would ever be approved or even reviewed.  The administration stated that the plaintiff’s claims are moot, and their alleged damages too speculative, outlining that there is “no timeline” for the approval of any programs and that states still have numerous hurdles to get past before any such programs could be approved or begin operation.

Taken at face value, these statements from the new administrations’ HHS, while not necessarily indicating a position against these programs, suggested that they are not a priority.  This was a discouraging development for stakeholders with programs currently waiting for review and approval.

Now, the recent executive order seemingly has the Trump-era importation programs back on track.  It states matter-of-factly that “…the Commissioner of Food and Drugs shall work with States and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173, 117 Stat. 2066), and the FDA’s implementing regulations.”  In most circumstances, restating directives from existing executive orders and regulations, with no changes, would not be noteworthy.  However, this simple statement confirms the new administrations intent to continue these programs, which will be reassuring to many. As was the case previously, it remains to be seen how the adoption and endorsement of “public” importation programs will impact the government’s treatment of those operating in the private sector, which could soon have new competition.