Endo International units sue FDA over drug compounding policy

BOSTON (Reuters) - Endo International Plc said two units filed a lawsuit on Thursday accusing the U.S. Food and Drug Administration of ignoring key components of a law passed after a deadly 2012 meningitis outbreak linked to a compounding pharmacy.

In a lawsuit filed in federal court in Washington, the Endo subsidiaries alleged that the FDA had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s blood pressure drug Vasostrict.

The lawsuit comes after FDA Commissioner Scott Gottlieb said in September the agency was working on a new policy that would encourage more compounding pharmacies to register under the Drug Quality and Security Act of 2013.

That law was passed after a fungal meningitis outbreak linked to contaminated steroids manufactured by New England Compounding Center in 2012 that prosecutors say killed 76 people and sickened hundreds more.

A federal jury in Boston on Wednesday found the former supervisory pharmacist at Massachusetts-based NECC, Glenn Chin, guilty of racketeering and fraud charges, while clearing him of second-degree murder.

Matthew Maletta, Endo’s chief legal officer, said in a statement that Endo welcomed Gottlieb’s efforts to develop a new policy but decided to sue “because we believe the status quo is unlawful.”

The FDA declined to comment.

Traditionally, pharmacists who compounded medications mixed tailored doses for individual patients in response to a specific prescription.

By the time of the meningitis outbreak, the practice had mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.

The 2013 law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk without prescriptions for individual patients while following federal manufacturing standards.

Endo said the law also required the FDA to determine that bulk compounding using a particular drug substance was necessary to satisfy an unmet “clinical need” and to include those substances on a list.

Endo said the FDA instead established a different system that authorized bulk compounding without the legally mandated scrutiny, while ignoring a prohibition on compounding copies of FDA-approved drugs.

In particular, Endo said the FDA had in July authorized the large-scale production of Vasostrict’s active ingredient, vasopressin, after an outsourcing facility, QuVa Pharma, nominated it for inclusion on the list.

Endo’s Par Pharmaceutical unit is separately suing QuVa, saying it misappropriated trade secrets related to Vasostrict. QuVa’s lawyer did not respond to a request for comment.

Reporting by Nate Raymond in Boston; Additional reporting by Divya Grover in Bengaluru; Editing by Peter Cooney