New England Compounding Center meningitis outbreak
A New England Compounding Center meningitis outbreak which began in September 2012 sickened over 800 individuals and resulted in the deathIn September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and other infections among patients who had received contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. The NECC was classified as a compounding pharmacy. Such pharmacies are authorized to combine, mix, or alter ingredients to create specific formulations of drugs to meet the specific needs of individual patients, and only in response to individual prescriptions.
In October 2012, an investigation of the NECC revealed the company had been in violation of its state license because it had been functioning as a drug manufacturer, producing drugs for broad use rather than filling individual prescriptions. In December, federal prosecutors charged 14 former NECC employees, including president Barry Cadden and pharmacist Glenn Chin, with a host of criminal offenses. It alleged that from 2006 to 2012, NECC knowingly sent out drugs that were mislabeled and unsanitary or contaminated.
In a congressional hearing the FDA Commissioner was asked why regulators at the FDA and the Massachusetts Board of Pharmacy did not take action against the pharmacy years earlier. The legislators were told that the agency was obligated to defer to Massachusetts authorities, who had more direct oversight over pharmacies. The FDA Commissioner also stated, "In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding." The Drug Quality and Security Act (H.R. 3204), a bill to grant the FDA more authority to regulate and monitor the manufacturing of compounding drugs, was passed by the Senate on November 27, 2013.
The incident resulted in numerous lawsuits against NECC. In May 2015, a $200 million settlement plan was approved that set aside funds for victims of the outbreak and their families.
