Endo International units sue FDA over drug compounding policy

Endo International announced two subsidiaries have sued FDA alleging it improperly authorized the bulk compounding of hundreds of drugs, including "essentially a copy" of Endo's blood pressure drug vasopressin (Vasostrict).

Endo International announced two subsidiaries have sued FDA alleging it improperly authorized the bulk compounding of hundreds of drugs, including "essentially a copy" of Endo's blood pressure drug vasopressin (Vasostrict). The lawsuit comes after FDA Commissioner Scott Gottlieb said last month the agency was working on a new policy that would advise more compounding pharmacies to register under the Drug Quality and Security Act of 2013. The law created a category of "outsourcing facilities" that could register with FDA, enabling them to sell products in bulk without prescriptions for individual patients while following federal manufacturing standards. In the lawsuit filed in federal court in Washington, Endo accused FDA of establishing a different system that authorized bulk compounding without the legally required scrutiny, and ignoring a rule against compounding copies of FDA-approved drugs. Matthew Maletta, Endo's chief legal officer, said the company approved of Gottlieb's efforts to develop a new policy but is suing "because we believe the status quo is unlawful."