Regulators repeatedly passed up opportunities to crack down on a Massachusetts pharmacy blamed for an outbreak of fungal meningitis that has killed 36 people and made 541 sick, the Boston Globe reported Monday.
Barry Cadden, the pharmacist who started up the New England Compounding Center, boasted about taking the pharmacy national even as he promised state regulators that he wanted to supply only locally, the newspaper reported. And the Food and Drug Administration handed over responsibility for monitoring NECC to the state pharmacy board even as Cadden made good his promise to expand beyond his license.
Compounding pharmacies like NECC are supposed to supply drugs on an individual, prescription-by-prescription basis. But NECC was mass-producing and mass-distributing drugs, state and federal regulators have found.
“By 2002, the year the FDA started investigating the firm, it was clear that New England Compounding’s strategy went far beyond the local focus Cadden had promised. Yet state and federal regulators did next to nothing to slow its growth,” the Globe reports.
Cadden set up an exhibit at a 2003 meeting of eye doctors, aggressively marketed NECC’s products and co-sponsored the Eastern Pain Association meeting in New York in 2005.
NECC is now closed and both the FDA and state regulators are trying to figure out how things went so badly wrong.