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Steroid Firm Was Investigated By Mass. In 2006

BOSTON — Federal health officials say there may be hundreds or even thousands of people exposed to a rare form of fungal meningitis. The Centers for Disease Control and Prevention said Saturday more than 60 people have been sickened in nine states, including seven who have died.

Framingham Pharmacy At Center Of Outbreak

The CDC has said the outbreak may have been caused by a steroid — methylprednisolone acetate, commonly used to treat back pain — made by a specialty pharmacy in Massachusetts, the Framingham-based New England Compounding Center.

Inspectors found at least one sealed vial that was contaminated, but it is not yet clear how the fungus got into the steroid. Officials have told health professionals not to use anything made by NECC.

Earlier State Investigation

In 2006, Massachusetts regulators investigated NECC, resulting in a consent agreement between the company 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 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.

NECC Response To Outbreak

Compounding pharmacies produce custom-mixed medications for treatment of various conditions. NECC has recalled 17,676 single-dose vials of the steroid, and the company suspended operations pending ongoing investigations by the FDA, the CDC 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.

Spread Of Outbreak

So far, the government has identified about 75 facilities in 23 states that received the recalled doses of methylprednisolone acetate.  The CDC has called for clinics and doctors to immediately identify those who could have been exposed between July 1 and September 28.

It is not yet clear exactly how many people could get sick, though health officials say the fungus is not transmitted from person to person.

Massachusetts Status

There have been no reports of illnesses associated with methylprednisolone acetate in Massachusetts.

In a statement released Friday, public health officials said state regulations permit pharmacists to dispense compounded medication to an individual patient with a prescription from a registered practitioner.

With reporting from Associated Press writers Bruce Schreiner, Kristin M. Hall and Bob Salsberg.

 

 

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