Dive Brief:
- In 2012, a tainted batch of injectable steroids mixed at the New England Compounding Center (NECC) led to a meningitis outbreak that killed more than 60 people and infected roughly 750 people. 14 pharmacy execs were arrested in connection to the outbreak last December, and two were charged with murder.
- NECC was shut down in October 2012. For the first three quarters of that year, NECC generated $32 million in revenues, mainly from bulk sales. A bankruptcy court has approved a reorganization plan under which the defunct pharmacy will pay out $200 million to victims and creditors, including $18 million seized from the company's founders and chief pharmacist.
- Deaths of patients occurred in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee, and Virginia.
Dive Insight:
Not long ago, compounding pharmacies were seen as alternatives to traditional pharmacies—a way to obtain more "natural" or "custom-made" drugs. FDA oversight over these entities was minimal. However, that has all changed since the negligent actions of the NECC and the decisions made by company managers such as Glenn Adam Chin, a former supervising pharmacist, led to the deaths of dozens of people and the infections of hundreds more.
In fact, 14 people from NECC are facing criminal charges and Chin, who attempted to board a plane for Hong Kong in September 2014, faces second-degree murder charges.
While it took a tragedy to get the FDA and lawmakers in Congress to take action, there is now tighter scrutiny of compounding pharmacies. The FDA has proposed new laws that would cap interstate shipments at 30%, as well as a law that would require any biologic that is mixed, diluted, or repackaged by a compounder to be administered within four hours, or be thoroughly tested for microbial contamination.