FDA Was Slow To Regulate Meningitis-Linked Center
FDA acted slowly to regulate the New England Compounding Center, the Massachusetts facility linked to a nationwide fungal meningitis outbreak, according to internal documents released last week. The documents show that after uncovering unsafe practices at NECC that could potentially harm individuals, FDA took 684 days to issue a warning letter. Barry Cadden -- NECC co-owner and chief pharmacist -- said the agency's response time "contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products."
- "Oversight Failures Documented in Meningitis Outbreak" (Pollack/Tavernise, New York Times, 11/21).
- "FDA Took 684 Days To Warn Meningitis-Linked Firm" (McLaughlin, Reuters, 11/21).