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 By Nate Raymond
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.
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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)
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