FDA took 684 days to warn meningitis-linked firm: files
BOSTON | Wed Nov 21, 2012 10:32am EST
(Reuters) - The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.
The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released by a Freedom of Information Act request from Reuters.
Since the FDA's December 2006 warning letter to NECC, both sides have come under intense scrutiny. State and federal regulators, including the FDA, are being asked why they didn't move sooner against NECC, given a long history of concerns about the family-owned pharmacy's operations.
The Centers for Disease Control and Prevention said 34 people have died and 490 have been injured after Framingham, Massachusetts-based NECC shipped thousands of fungus-tainted vials of methylprednisolone acetate to medical facilities throughout the United States. The steroid was typically used to ease back pain.
http://www.reuters.com/article/2012/11/21/us-usa-health-meningitis-fda-idUSBRE8AK0T520121121The government that we support, lock, stock and barrel, doesn't protect us. Private and quasi-private companies charge us more, but they don't do their jobs, either.
When the hell do we get to hold anyone accountable?