Serious GMP Violations might bring 14 Employees of a New England Compounding Center to Jail

Recommendation

Thursday, 2 May 2024 13.30 - 18.00 h

Excel in the GxP-regulated Environment - Live Online Training

The US department of Justice has indicted 14 people connected with the New England Compounding Center (NECC). The company has been accused of manufacturing substandard products which do not comply with the GMP regulation. As a consequence of the serious GMP violations "contaminated vials of preservative-free methylprednisolone acetate (MPA) were produced and 751 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA.  Of those 751 patients, the CDC reported that 64 patients in nine states died."

According to a press release by the US department of Justice "twelve other individuals, all associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and one other individual were charged with additional crimes including racketeering, mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug and Cosmetic Act." The owner of NECC and head pharmacist, Barry Cadden, as well as its supervisory pharmacist, Glenn Chin, were charged with 25 acts of second-degree murder and additional crimes.

In a New York Times article Daniel C. Richman, a law professor at Columbia University said: “It certainly is a dramatic move to label what was happening as fraud and tie that to murder, instead of casting it as regulatory violations. That frames the misconduct in stark criminal terms.”

However, the department of Justice is convinced that the major responsible persons involved in the case knew about the GMP violations for a long time and are therefore personally responsible for the tragic consequences. The FDA Form 483 (which contains the findings written by the GMP Investigators) was already published by the FDA in 2012 and contained various violations, especially in the area used for the preparation, filling and storage of sterile drug products.