Endo agrees to additional stay of FDA litigation

Endo International announced that it has agreed to an additional stay of its litigation against the FDA until December 31, 2018. The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by the company’s subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, seeks a declaration that FDA’s “Interim Policy” on compounding using bulk drug substances under Section 503 B of the Drug Quality and Security Act of 2013, or DQSA, amendments to the Federal Food, Drug, and Cosmetic Act, or FDCA, is contrary to law because it authorizes bulk compounding of new drugs where the applicable DQSA requirements are not satisfied and because it is fundamentally inconsistent with the plain language and structure of the FDCA statutory regime for introducing new drugs. The litigation also seeks the immediate removal of vasopressin from FDA’s Category 1 nominations list to assure that outsourcing facilities do not engage in bulk compounding of vasopressin-containing drug products under Section 503B. Shortly after Endo commenced the litigation, FDA took initial steps to comply with the DQSA and Endo agreed to FDA’s prior stay requests in January 2018 and April 2018. In August 2018, an outsourcing facility announced it would commence bulk compounding of vasopressin and intervened in the litigation. Endo promptly lifted the litigation stay and filed a motion for preliminary injunction. Seven days after Endo filed its motion, FDA published a proposed clinical need determination for vasopressin in the Federal Register indicating that it “find[s] no basis to conclude that there is a clinical need for an outsourcing facility to compound using the bulk drug substance vasopressin” and initiated a 60-day comment period. If FDA finalizes its proposed clinical need determination following the comment period, bulk compounding of vasopressin will be illegal and subject to FDA enforcement. During discussions between Endo’s and FDA’s respective counsel on September 20, 2018, FDA advised Endo that FDA would commit to use its best efforts to finalize its clinical need determination for vasopressin by December 31, 2018 if Endo agreed to again stay the litigation until such date. Based on FDA’s commitment, Endo agreed to the proposed stay and the parties jointly moved the court for approval on September 21, 2018. The motion was unopposed by the intervenor outsourcing facility. If the court approves the proposed stay, Endo’s motion for preliminary injunction will be held in abeyance and the hearing on such motion that is currently scheduled for October 3, 2018 will be taken off calendar.
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