Drug Importation Lawsuit Stays Alive, For Now

Arent Fox

Arent Fox

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.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Arent Fox | Attorney Advertising

Written by:

Arent Fox

Arent Fox on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.