Steroid Firm Was Investigated in 2006
BOSTON (AP) — The company at the center of a probe into a deadly meningitis outbreak in seven states was investigated by Massachusetts regulators in 2006, resulting in an agreement to shore up some of the firm's procedures.
The investigation resulted in a consent agreement between New England Compounding Center and the state's Board of Registration in Pharmacy, which has regulatory oversight over the company. The agreement settled complaints initially made to the U.S. Food and Drug Administration about methylprednisolone acetate, the same steroid recalled by the company last week and linked to nearly 50 cases, including five deaths, of the rare fungal meningitis.
The company, according to the January 2006 consent agreement released late Friday by state public health officials, agreed to a full inspection by an outside evaluator of its drug compounding practices, including sterility, environmental monitoring, cleaning and sanitizing, and quality assurance program.
The agreement was signed by NECC's pharmacy director, Barry Cadden.
In June 2006, the then-president of the state board, George Cayer, sent a follow-up letter to Cadden advising the company that it had "satisfactorily completed the terms and conditions" in the agreement, though NECC was still required to update its standard operating procedures every two years.
As part of the "nondisciplinary" consent agreement, the company was placed on probation for one year, but the probation was stayed as part of the agreement and no fines or other punitive action were ordered.
The FDA separately sent NECC a warning letter in 2006 covering several alleged violations, including one related to the repackaging of Avastin, an injectable cancer drug.
Compounding pharmacies produce custom-mixed medications for treatment of various conditions. NECC has recalled 17,676 single-dose vials of the steroid that was used for back pain, and the company suspended operations pending ongoing investigations by the FDA, the U.S. Centers for Disease Control and Massachusetts regulators.
A spokesman for NECC said the company would have no further comment Friday. It has previously said that it is cooperating with health investigators to determine the source of the infections.
Messages left earlier in the day with members of the state pharmacy board were not immediately returned.
There have been no reports of illnesses associated with methylprednisolone acetate in Massachusetts. State public health officials, in a statement released Friday, said state regulations permit pharmacists to dispense compounded medication to an individual patient with a prescription from a registered practitioner.