Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential importation of drugs that are (1) off-patent; (2) have no exclusivity remaining; (3) face no generic competition; and (4) can be imported with adequate assurances of safety and effectiveness. Scott Gottlieb’s statement further narrowed the scope of the working group’s task to: “Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories.”

Although there has been little visible sign of the working group’s activity, now the HHS Secretary is facing pressure to approve State drug importation plans that will likely be much broader than the original scope of drug importation that the working group had been asked to consider. These State drug importation plans are likely to be contrary to longstanding HHS and FDA positions opposing such programs based on safety concerns and inadequate cost savings. Moreover, HHS certification of the State plans would need to overcome certain legal barriers that exist under current Federal law.