FDA requests further stay of Endo’s ongoing litigation

Endo International announced that, due to the ongoing federal government shutdown, the U.S. FDA has requested a further stay of Endo’s ongoing litigation against the FDA for the duration of the shutdown. That litigation challenges the FDA’s authorization of the bulk compounding of drugs, including vasopressin, that have not satisfied the legal requirements under Section 503B of the Drug Quality and Security Act amendments to the Federal Food, Drug, and Cosmetic Act. One of Endo’s subsidiaries, Par Sterile Products, LLC, manufacturers the only vasopressin product currently approved by the FDA, Vasostrict. The suit was most recently stayed until December 31, 2018 and the FDA had committed to use its best efforts to issue a final clinical need determination for vasopressin on or before that date. The FDA has now filed a motion, which Endo did not oppose, seeking a further stay of the suit for the period of time in which the government lacks appropriations. According to the FDA’s motion, absent an appropriation, Department of Justice attorneys and the FDA employees responsible for handling Endo’s litigation and the clinical need determination, respectively, are prohibited from working, even on a voluntary basis, except in very limited circumstances. If the FDA’s motion is granted, the litigation will be stayed for as long as the appropriations lapse continues and Endo is not at this time aware when appropriations may resume.

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