|
Endo International plc announced that it is lifting a temporary stay of its litigation against the US Food and Drug Administration (FDA). The litigation, filed in the US District Court for the District of Columbia in October 2017 by the company's subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, LLC (collectively, Endo), 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 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.
In light of an outsourcing facility's recent announcement that it has launched a ready-to-use vasopressin product compounded using bulk drug substances under Section 503B, Endo is lifting the stay of its litigation against FDA. "Bulk compounding of vasopressin under Section 503B is inappropriate and undermines the longstanding new drug approval framework of the Federal Food, Drug, and Cosmetic Act," said Matthew J. Maletta, executive vice president and chief legal officer of Endo. "We previously stated that in the event an entity were to commence bulk compounding of vasopressin under Section 503B prior to FDA's implementation of a new compounding policy, we would lift the stay of our litigation against FDA. Yesterday we did just that, and we will file a motion for preliminary injunction vacating the listing of vasopressin on FDA's Category 1 bulk drug substances list and preventing FDA from authorizing bulk compounding using vasopressin in a manner that does not comply with applicable laws."
In January 2018, following public statements from FDA reflecting FDA's intent to alter its compounding policy, and after discussions among the parties' counsel, Endo agreed to FDA's request to stay the parties' litigation until March 30, 2018. Under the terms of the litigation stay, Endo retained the ability to terminate the 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 later agreed to extend the temporary litigation stay for an additional 180 days following FDA's issuance in March 2018 of draft guidance describing the procedures that FDA intends to follow, and the criteria that FDA intends to apply, in implementing the requirements of the DQSA for use of bulk drug substances in compounding under Section 503B. In the draft guidance, FDA states, among other things, that because "compounded drug products are subject to a lower regulatory standard than FDA-approved drugs, they should only be used by patients whose medical needs cannot be met by an FDA-approved drug." FDA further explains that in certain situations, "compounding using the FDA-approved drug product instead of a bulk drug substance would meet patients' medical needs and present less risk," and specifically describes the dilution of FDA-approved drugs by outsourcing facilities to produce intravenous bags for hospitals as such a situation.
|