BRIEF—Endo agrees to FDA's request to seek temporary litigation stay

Ireland-incorporated Endo International has agreed to a request by the US Food and Drug Administration to seek a temporary stay of the litigation initiated against the FDA in October 2017 by the company's subsidiaries, Par Sterile Products and Endo Par Innovation.

The litigation, filed in the US District Court for the District of Columbia, seeks a declaration that FDA's "Interim Policy" on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 (DQSA) amendments to the Federal Food, Drug, and Cosmetic Act (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 the 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.

Based on the January 18, 2018 public statements from the FDA reflecting its intent to alter its compounding policy and comply with the DQSA, as well as subsequent discussions among the parties' counsel, Endo has agreed to FDA's proposed litigation stay until March 30, 2018, subject to, among other things: (1) FDA using its best efforts to issue further clarification of the proposed conditions for bulk compounding by that date; and (2) Endo retaining the ability to terminate the litigation stay by notifying FDA that it believes that an entity has commenced or is likely to commence bulk compounding of any vasopressin-containing drug product under Section 503B.