Endo International plc has agreed to a request by the U.S. Food and Drug Administration (FDA) to seek a temporary stay of the litigation initiated against FDA in October 2017 by the company’s subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, LLC.

The litigation, filed in the U.S. 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. 

It 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. 

Based on the January 18, 2018 public statements from 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.

“Endo brought this lawsuit because FDA violated the DQSA by issuing an improper ‘Interim Policy’ and by listing vasopressin as a ‘Category 1’ substance that outsourcing facilities could use in bulk compounding under Section 503B,” Matthew J. Maletta, executive vice president and chief legal officer of Endo, said. “FDA’s recent public statements indicate that it is now taking steps to comply with the DQSA and that it plans to announce further details by the end of March 2018. 

In its recently issued 2018 Compounding Policy Priorities Plan, FDA explains that:   

• “Because of the profound public health implications, the FDA’s compounding program is a priority for the agency and the FDA is committed to implementing the DQSA framework” 
    
• FDA intends “to prioritize review of situations that could adversely impact the public health and premarket approval process, such as compounding using a bulk drug substance to produce a product that can otherwise be made by diluting an FDA-approved drug according to its labeled instructions,” and 
          
• “The FDA’s decisions will be guided by the conditions set forth in the statute, so that bulk drug substances are placed on the 503B bulks list only when there is clinical need to compound drugs using these substances.  This protects patient health and the drug approval process, for example, by helping to ensure that outsourcing facilities do not compound using a bulk drug substance when an FDA-approved drug can be used to meet patient medical needs.”

“We look forward to continuing our dialog with FDA and we are hopeful that the policy changes FDA has described, once effective, will address the multiple concerns that led Endo to file this case,” Maletta said.

(Source: Endo International plc)