$100M fund outlined for victims of NECC manufacturing problems

A fungal meningitis outbreak last year that sickened more than 750 people, killing dozens, led to new authority by the FDA to regulate large compounding pharmacies like New England Compounding Center (NECC), the company that the outbreak was traced back to. The shutdown of NECC eventually resulted in its bankruptcy, leaving victims and their families in doubt of receiving any compensation. But at year end, owners, operators and insurers of the bankrupt compounding pharmacy came to a preliminary agreement to set up a victims' fund that could surpass $100 million. The public outcry from the outbreak resulted in Congress last fall passing the Drug Quality and Security Act, which gives the FDA new, but limited, powers to oversee compounding pharmacies that volunteer to be regulated. The idea is that FDA oversight will set these companies apart and that hospitals will use those operators that agree to the stricter oversight. Separately, the law sets up a timeline for the drug industry to begin a so-called national track-and-trace system, with the intent of making it possible to eventually electronically track individual drug packages from production to patient. Story | More