In our earlier blog about the 2010 Heparin Incident, you saw evidence of how a tragic failure in the supply chain led to increased scrutiny in supplier controls. In this post I will outline a more recent tragedy – – this time with its roots in the distribution chain.
In 2012, fungal meningitis has killed 32 Americans in 19 states and caused sickness to over 450 patients. The meningitis has been traced to the Massachusetts-based New England Compounding Center (NECC) which compounded and distributed contaminated pain injections.
Compounding pharmacies like NECC fill special orders, placed by doctors, that are tailored to individual patient needs. Often small family-run businesses, these pharmacies typically fulfil a small number of customized formulas each week and have been policed by state pharmacy boards in the U.S. However, some of these companies have grown significantly and now ship thousands of formulations of finished drugs to multiple states. NECC is one such company. Its operations more closely resemble those of a large manufacturing business than the “Mom & Pop” image of a local pharmacy.
After investigations of the meningitis outbreak by laboratories at the U.S. Food and Drug Administration (FDA) and Center for Disease Control (CDC), the FDA has said: “The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free injectable betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.“ U.S. state and federal officials, relatives of the deceased and other victims are in the process of giving testimony at a Congressional Hearing. This story is drawing widespread commentary in the media and appears to point to a blind spot in regulatory oversight of these specialist businesses, especially compounders who have grown to a significant scale.
The roots of the Heparin incident were found to be in China, an emerging region in terms of its activity on the newly globalized supply chain. However, what I find remarkable about the NECC incident is that it occurred in Massachusetts, a center of excellence in the global life science industry and one of the most robust and mature regulatory environments in the world. These incidents are at opposite reaches of the supply and distribution chains, yet the failures in Good Practice (GxP) that led to these deaths are very basic by the standards of modern day healthcare.
FDA Commissioner Margaret Hamburg has been grilled by the House Committee and much of the debate has centered on overlap (or lack thereof) of the agency’s federal reach relative to the role of individual states in policing pharmacies. In light of the NECC case, Hamburg’s important speech of January 2010 “Protecting Health: FDA’s Global Challenge” contained some prescient commentary.