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Following a favorable May 17 Letter (the “Letter”) issued by HHS requiring six drug companies to restart 340B pricing on drugs shipped to contract pharmacies or risk civil monetary penalties, several of the drug companies filed separate motions in their respective cases challenging the Letter.  These motions are:

  • May 19/May 21, 2021: AstraZeneca filed an emergency motion for administrative stay and, in the alternative, for expedition seeking to stay the Letter until the court can resolve its dispute.  The next day, the court ordered HHS, by 11:00 am on May 21, to file a letter brief responsive to AstraZeneca’s motion.  Today, HHS filed a letter brief with the court stating that the emergency motion should be denied because it was “procedurally improper [and] logically incoherent”.  HHS argues that AstraZeneca must, among other things, first amend its complaint to challenge the Letter, point to laws that would allow the court to grant a stay prohibiting enforcement of the Letter, and address factors that would support the court granting the emergency motion.
  • May 20, 2021: Eli Lilly filed a motion for preliminary injunction and temporary restraining order seeking to “bar Defendants from taking any adverse action against Lilly related to the 340B program based on [HHS]’s interpretation of the statute … until after [the] Court issues final judgment on Lilly’s claims.”  Lilly also requests that the Court grant a temporary restraining order in the interim to maintain the status quo until its preliminary injunction request has been resolved.
  • May 21, 2021: Sanofi filed a joint motion to expedite the hearing on its motion for summary judgment (the hearing is currently scheduled for June 21) and also to stay HHS’s enforcement of the Letter.

As expected, the drug companies are moving to halt HHS’s enforcement of the 340B statute and their responsibility to “offer” 340B pricing on drugs shipped to contract pharmacies, despite over twenty years of honoring contract pharmacy arrangements.  At this time, Novo Nordisk has not made a similar filing in its case.