Drug Importation Lawsuit Stays Alive, For Now

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”

Arent Fox previously summarized that EO here. Among other directives, the EO specifically directed HHS to complete a rulemaking to allow the importation of certain prescription drugs from Canada.

A final rulemaking that would allow the importation of brand name drugs from Canada faced strong opposition from the pharmaceutical manufacturer community, which led PhRMA and other interested parties to file a lawsuit against HHS with the United States District Court for the District of Columbia (the Court) to invalidate the final importation rule. With the change of administrations in January 2021, it was not immediately clear whether the Biden Administration would continue to defend the lawsuit or not. But recent action in the case indicates that the current administration will continue to do so and that the case remains alive.

The Department of Justice filed a motion to dismiss the case on May 28, 2021, arguing that the Plaintiffs lack standing and subject matter jurisdiction and that their claims are not constitutionally ripe due to a lack of “any actual or imminent injury.” However, rather than rule on that motion, the Court issued an order on June 9, 2021, which grants the Plaintiffs the ability to file an amended complaint by July 2, 2021. 

Presumably, the amended complaint will address the issues of standing and injury with greater specificity. Arent Fox will continue to monitor this case and provide updates and analysis on our blog.


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