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New England Compounding Center’s history

NECC

April ’02: At least two patients sickened; NECC steroid, betamethasone, suspected.

July ’02: At least two patients sickened; another NECC steroid, methylprednisolone, suspected. NECC expands, hires marketing staff, and becomes licensed in Connecticut and Florida.

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Feb./May ’03: NECC co-owner Barry Cadden tells FDA he’s hired a consultant and made improvements.

April ’04: Family of William Koch, who died of meningitis after receiving a contaminated steroid injection in 2002, sues NECC. Case later settled.

Oct. ’04: Board drafts consent agreement requiring three years probation and reprimand for NECC and Cadden.

Nov. ’04: Cadden’s lawyer objects to disciplinary action, says it could destroy NECC, which is now licensed in 43 states.

Jan. ’06: Consent agreement goes into effect with no reprimand and one year probation, which is stayed.

June ’06: Pharmacy board tells Cadden that NECC has successfully completed the terms of the consent agreement and improved procedures.

July ’06: Cadden and his family start a new drug-distribution business focused on hospitals, Ameridose.

Jan. ’07: Cadden strongly objects to FDA warning, saying too much time has passed since inspections.

May ’11: Pharmacy board inspection for NECC expansion is “satisfactory.”

Sept. ’12: Tennessee health department notifies Centers for Disease Control and Prevention of first case of fungal meningitis in a patient who received an injection of NECC’s methylprednisolone.

Dec. ’12: 541 people sickened, including 36 who have died.

FDA INVOLVEMENT

April ’02: The FDA and state launch inspection, find poor sterility procedures.

Aug. ’02: New FDA and state inspection discovers more problems.

Feb. ’03: FDA tells pharmacy board it is worried about “serious public health consequences’’ from NECC’s “poor compounding practices.”

Sept. ’04: FDA and state pharmacy board inspect NECC for compounding unapproved drug, among other allegations. State issues advisory letters to Cadden involving complaints for allegedly improperly soliciting prescriptions out of state. Board requires company to make quality improvements, but issues no discipline.

Dec. ’06: FDA warning letter sent to Cadden about serious problems found during past inspections.

Oct. ’08: FDA issues final letter to Cadden. Threatens the pharmacy with future action, but never follows through, until recent meningitis outbreak.

Oct. ’12: FDA and CDC recommend all health care providers immediately stop using NECC products for fear they are contaminated with fungus.

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