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posted: 10/23/2012 7:16 PM

Firm in meningitis case: Officials inspected

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  • Dr. Madeleine Biondolillo, director of the Massachusetts Bureau of Healthcare Safety, addresses reporters in Boston on Tuesday regarding the Massachusetts pharmacy responsible for the meningitis outbreak. The outbreak has sickened nearly 300 people, including 23 who died, in more than a dozen states.

      Dr. Madeleine Biondolillo, director of the Massachusetts Bureau of Healthcare Safety, addresses reporters in Boston on Tuesday regarding the Massachusetts pharmacy responsible for the meningitis outbreak. The outbreak has sickened nearly 300 people, including 23 who died, in more than a dozen states.
    ASSOCIATED PRESS

 
Associated Press

BOSTON -- An attorney for a Massachusetts company linked to a deadly meningitis outbreak says it's "hard to imagine" state regulators didn't know the scale of its operations because it's worked so closely with them.

The statement by New England Compounding Center attorney Paul Cirel came Tuesday after Gov. Deval Patrick announced the state has moved to revoke the company's operating license.

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State officials say they found unclean conditions at the company and evidence it was making drugs for general distribution, a violation of its license.

Patrick says he's ordered regulators to conduct surprise inspections at similar types of pharmacies.

The company's attorney says regulators have always had complete access to the facility and inspected it last summer. He says the company's transparency shows its good-faith intention to operate within the bounds of its license.

The first such unannounced inspection was done at a compounding pharmacy on Tuesday, state health department spokesman Alec Loftus said. He would not reveal the name of the facility and said results of the inspection were being reviewed.

State officials said a preliminary investigation found that the NECC shipped orders from the lots of steroid shots suspected in the meningitis outbreak before its own tests came back confirming the lots were sterile. In some cases, they said, drugs went out up to 11 days before test results came back.

Officials also said the company, in Framingham, just west of Boston, operated as a drug manufacturer by producing drugs for broader use, rather than filling out specific prescriptions for specific doctors, which is all its license allowed.

"Over the years and for a variety of reasons, some pharmacists have transformed from your neighborhood drugstore into large-scale manufacturers that sell products across state lines," Patrick said.

The outbreak of meningitis, an inflammation of the lining of the brain and spinal cord, has sickened nearly 300 people, including 23 who died, in more than a dozen states. Each victim had received a steroid shot, mostly for back pain. Federal health officials matched the shots produced by the company to the outbreak after finding a deadly fungus in more than 50 unopened vials there but have not said how the shots were contaminated.

New state documents released this week detailed problems an outside firm hired to do an assessment found there years ago.

The state documents, obtained by The Associated Press under a public records request, say investigators in 2006 found inadequate contamination control and no written standard operating procedures for using equipment, among other problems. The problems were corrected that year, and a state inspection in May 2011 as the company prepared to update its facilities found no such issues.

In a letter sent Monday to a lawyer for NECC, the U.S. House Committee on Energy and Commerce sought nearly 10 years of documents about safety and quality issues at the company. It indicated that as far back as 2002 and 2003 officials from the Food and Drug Administration and the state conducted joint probes of the company after receiving a report about a steroid shot. Those probes preceded a 2004 joint investigation of the center by the FDA and the Massachusetts Board of Registration in Pharmacy.

In January 2006, based on several complaints, the company signed with state regulators a consent agreement in which it agreed to a full inspection of its drug compounding practices by investigators.

The company's encounters with regulators have been reported since the outbreak began, but state pharmacy board documents released Monday offer a new level of detail. They show the inspection by Illinois-based Pharmaceutical Systems Inc. found "significant gaps" in procedures and a lack of required documentation at the NECC facility.

NECC spokesman Andrew Paven said he hadn't seen the committee's letter but the company continues to cooperate with the ongoing investigation.

"NECC worked cooperatively with the Massachusetts Board of Registration in Pharmacy to resolve to the Board's satisfaction any issues brought to the company's attention," he said by email.

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