Massachusetts regulators in 2004 proposed a formal reprimand for a company now linked to deadly meningitis outbreak, but they never delivered it after the company protested the reprimand could be "fatal to the business."
The sanction by the Board of Registration in Pharmacy was included in a proposed consent agreement that was meant to resolve complaints against the New England Compounding Center in Framingham. The complaints included a failure to meet accepted standards for making the same steroid that's been connected to the outbreak.
The agreement was among documents released this week by the state Department of Health that provide more details about past incidents at NECC, which was shut down in the wake of the fungal meningitis outbreak that has reached 17 states, sickening 317 people, 24 of whom have died. The outbreak has been linked to a steroid made by the NECC and taken mainly for back pain. Compounding pharmacies like NECC custom mix solutions in doses or forms generally not commercially available.
The state has now moved to revoke NECC's license, but the reprimand represents a missed opportunity to crack down on the lab years before the current outbreak.
The proposed consent agreement, sent to owner Barry Cadden for review in October 2004, included the reprimand and a three-year probationary period for the company's registration and Cadden's license.
TVNL Comment: There is no regulation or oversight by any government agency to assure that compounds produced by these pharmacies are safe. None at all. People die. No big deal.