Endo files lawsuit to obtain FDA compliance with Drug Quality and Security Act of 2013

Ireland-incorporated Endo International (Nasdaq: ENDP) has revealed that two of its subsidiaries have filed suit in the US District Court for the District of Columbia against the Food and Drug Administration seeking a declaration that the FDA's current framework allowing for the bulk compounding of numerous products is unlawful under the Drug Quality and Security Act of 2013 (DQSA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA).

The lawsuit also seeks the immediate removal of vasopressin from the FDA's Category 1 nominations list to assure that non-sterile-to-sterile outsourcing facilities cannot engage in bulk compounding of vasopressin. Endo filed the suit based on legislative provisions contained in the DQSA amendments requiring FDA to implement a regulatory framework regarding bulk compounding that serves to protect the public health.

"Endo welcomes FDA Commissioner Gottlieb's September 2017 press statement that FDA is working on a new compounding policy which we hope will include the legally required changes to FDA's regulatory framework," said Matthew Maletta, executive vice president and chief legal officer of Endo. "Nevertheless, because we believe the status quo is unlawful and because we have no certainty about FDA's plans, we feel compelled to bring this action in an effort to protect the public health and safety, together with our own investments in product development and the integrity of the new drug approval process established by the Hatch-Waxman amendments to the FDCA," he added.