published Wednesday, November 7th, 2012

Official fired for ignoring complaint against drug company in meningitis outbreak case

This undated photo made available by the Centers for Disease Control and Prevention shows a branch of the fungus Aspergillus fumigatus. The fungus can also cause skin infections if it enters a break in the skin. The meningitis outbreak is linked to the fungus being accidentally injected into people as a contaminant in steroid treatments. It's not clear how the fungus got into the medicine.
This undated photo made available by the Centers for Disease Control and Prevention shows a branch of the fungus Aspergillus fumigatus. The fungus can also cause skin infections if it enters a break in the skin. The meningitis outbreak is linked to the fungus being accidentally injected into people as a contaminant in steroid treatments. It's not clear how the fungus got into the medicine.
Photo by Associated Press /Chattanooga Times Free Press.

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 emails.

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 emailed Coffey.

The NECC has been closed since last month, and Massachusetts officials have taken steps to permanently revoke its license.

A company spokesman has said it was always the NECC’s intent to obey the law in every state in which it was licensed.

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