The New England Compounding Center is under scrutiny as investigators try to determine how a steroid solution supplied by the pharmacy apparently became contaminated with a fungus.(Photo: Stephan Savoia, AP)
BOSTON -- The Massachusetts pharmacy board's director has been
fired for ignoring a complaint that a company linked to a deadly
meningitis outbreak was shipping drugs in bulk, in violation of its
state license.
The Colorado pharmacy board complained about the
New England Compounding Center in July, before the third of three
batches of tainted steroids linked to the outbreak was shipped.
After
receiving the report, director James D. Coffey told Colorado officials
that the Board of Registration in Pharmacy would "respond as soon as
possible following a thorough analysis of (the report)."
Coffey forwarded the complaint to the board's attorney, Susan Manning, who also failed to act, state officials said.
The
two did not notify leadership at the state Department of Public Health
about the complaint, which investigators discovered last weekend while
looking through Coffey's e-mails.
Coffey was fired Tuesday; Manning has been placed on administrative leave. Their replacements have not been publicly announced.
Massachusetts
Interim Public Health Commissioner Dr. Lauren Smith said it was
"incomprehensible" that Coffey and Manning did nothing, especially given
past problems at the NECC.
"I also expect the staff charged with
oversight to perform their duties to the highest standards," she said.
"That failed to happen here."
The New England Compounding Center
in Framingham, outside Boston, was authorized only to fill specific
prescriptions for individual patients. Pharmacies that manufacturer
drugs in bulk are subject to federal oversight, and state officials have
accused the NECC of hiding its true nature as a drug manufacturer to
escape more stringent regulation.
A contaminated steroid produced
at the company and used mainly to treat back pain has been linked to a
meningitis outbreak that has spread to 19 states, sickening more than
400 people, including 31 who died.
The company recalled three
batches of steroids made since May that totaled 17,676 single-dose vials
of medicine. Massachusetts Office of Health and Human Services
spokesman Alec Loftus said investigators are still looking into any
sicknesses or deaths linked to that third batch, sent after the Colorado
pharmacy board complained.
Back in April 2011, the Colorado board
issued a cease and desist order for the NECC, ordering it to stop "the
unlawful distribution of prescription drugs in the state of Colorado"
after an inspector discovered NECC drugs stored for general use at a
hospital in Lone Tree, Colo.
In July, another inspector found bulk quantities of other NECC-made drugs at a hospital in St. Delta, Colo.
After
confirming with the U.S. Food and Drug Administration that the NECC was
not registered as a drug manufacturer, the Colorado officials e-mailed
Coffey.
The NECC has been closed since last month, and Massachusetts officials have taken steps to permanently revoke its license.
Associated Press