Meningitis Risk at NECC Pharmacy Known by FDA in 2002

The risk of patient illnesses were spotted by U.S. regulators more than a decade ago at the pharmacy linked to this years deadly meningitis outbreak, according to lawmakers investigating the governments response.

Procedures at New England Compounding Pharmacy Inc., known as NECC, may not have met standards for sterility, according to Food and Drug Administration inspection records from 2002 summarized by a House panel. At the time of the FDAs inspection, conditions at the Framingham, Massachusetts, facility were found to be similar to a California compounding pharmacy associated with three meningitis deaths a year earlier.

The regulators also said in 2002 that a hospital in Rochester, New York, linked an NECC pain-killing steroid, methylprednisolone acetate, to meningitis-like symptoms in two patients. The same drug is blamed for this years outbreak, which has infected 438 people, killing 32. While the FDA in 2002 suggested suspending operations, the law kept it from acting and the agency deferred action to Massachusetts authorities.

The state would be in a better position to gain compliance or take regulatory action against NECC as necessary, the FDA said in a February 2003 memo summarized yesterday by a subcommittee of the House Energy and Commerce Committee. The decision was made even as the FDA cited the potential for serious public health consequences.

The Energy and Commerce subcommittee on oversight and investigations plans a Nov. 14 hearing to ask FDA Commissioner Margaret Hamburg why the agency didnt pursue enforcement actions and how Massachusetts officials allowed NECC to keep its license. U.S. Representative Fred Upton, a Michigan Republican and chairman of Energy and Commerce, also sent a subpoena to NECC co-owner Barry Cadden.

The Senates health committee plans a hearing Nov. 15.

NECC was a specialty pharmacy permitted to mix drugs on a small scale that patients may not have been able to find elsewhere, such as those without preservatives or in a unique dose. It suspended operations Oct. 3 and recalled 17,676 doses of methylprednisolone acetate after regulators determined that tainted vials of the drug were responsible for fungal meningitis infections in 19 states.

Inspections by the FDA last month showed the company knew of elevated levels of mold and bacteria in January and no documented corrective actions were taken, according to a preliminary report that cited company documents.

The same steroid linked to the current meningitis outbreak also was the subject of some of the 2002 inspections. FDA tests in December 2002 found that four of 13 vials of methylprednisolone acetate tested positive for bacteria, though no deaths were linked to the products.

Meningitis is an inflammation of the lining of the brain and spinal cord. The government has said about 14,000 people received shots of the NECC steroid, which is injected into the spinal cavity to relieve neck and back pain.

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Meningitis Risk at NECC Pharmacy Known by FDA in 2002