FDA, DOJ arrest NECC pharmacist about to leave the country

Federal authorities have arrested a pharmacist that worked for the now bankrupt New England Compounding Center (NECC). The compounder's manufacturing failures are believed to be responsible for a fungal meningitis outbreak in 2012 that killed 64 people and sickened 751. The outbreak also led to a new law that expanded FDA powers to oversee some of the largest compounders.

The Justice Department says agents intercepted Glenn Adam Chin, 46, as he was boarding a plane in Boston last week, bound for Hong Kong. He was to be charged with mail fraud, a charge that they pointed out could carry up to 20 years in prison. He is the first person tied to the outbreak and the now-defunct NECC to be arrested, Reuters said. Authorities said the investigation is still ongoing, but they needed to keep Chin from leaving the country.

The DOJ says Chin was the supervising pharmacist at Framingham, MA-based NECC and was responsible for having technicians label its drugs as sterile and tested when they were not. According to Reuters, a document filed by an FDA agent says the drugs were manufactured, filled and held under unsanitary conditions. Chin specifically was accused of giving the OK for drugs shipped to Michigan Pain Specialists. After injecting patients with them, 217 contracted fungal meningitis, and 15 of those patients died.

The case publicized the big shift that had occurred in drug compounding. While many of them had become small multi-state operations, oversight remained primarily the responsibility of state authorities and enforcement was limited. The FDA was criticized for not having taken a larger role. Because the industry had fought federal oversight, the agency asked Congress for explicit authority to regulate the largest operators. Last year, Congress granted it some expanded powers--the authority to regularly inspect only those companies which voluntarily signed up for oversight, believing the market would punish bad players.


- here's the DOJ announcement
- read the Reuters story