Newly released documents reveal that the Food and Drug Administration (FDA) took 684 days to issue its December 2006 meningitis warning after discovering serious warning signs involving the Massachusetts-based pharmacy—the New England Compounding Center (NECC)—that sent thousands of fungus-laden batches of a steroid used to treat back pain.
According to the Center for Disease Control (CDC), the meningitis outbreak claimed 34 lives and injured 490 individuals.
NECC defense lawyers on Tuesday told a U.S. District Judge that no evidence exists linking the meningitis outbreak to the Massachusetts-based pharmacy.
According to Reuters:
The newly released documents reveal a combative side to NECC chief pharmacist, Barry Cadden, and his brother-in-law, Greg Conigliaro, the recycling entrepreneur who helped him launch the specialty pharmacy.
Inspectors said Conigliaro became indignant during a September 2004 inspection by the FDA and Massachusetts regulators, documents showed. At one point, Cadden told his brother-in-law, "Don't answer any more questions!" according to a 2005 FDA memorandum.
The inspectors had concerns about how NECC was compounding and dispensing Trypan Blue, a dye sometimes used in eye surgery. Inspectors also expressed concern about how NECC was repackaging Avastin, highlighting the threat of contamination when the pharmacy opened sterile containers of the cancer drug.
The FDA says it's sorry for the "significant delay" in issuing its warning 684 days after inspections raised red flags.