 Fungal cells (black lines) in infected brain tissue (cyan) | |
| Date | September 21, 2012 (on-going) |
|---|---|
| Location | United States (23 States) |
| Cause | Fungal contamination of steroid medication |
| Deaths | 64[1] to 100+[2][3][4] |
| Non-fatal injuries | 689[1] |
| Litigation | 400+ lawsuits filed against NECC |
A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 people.[2][3][4] In 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. The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can't be met by commercially available drugs.[5]
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 2012, 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.
- ^ a b "Multistate Outbreak of Fungal Meningitis and Other Infections – Case Count". CDC. 30 October 2015. Retrieved 25 July 2018.
- ^ a b Roche Jr., Walter F. "Number deaths caused by the 2012 fungal meningitis outbreak underreported". Nashville Tennessean. Retrieved November 7, 2019.
- ^ a b Brian E. Dickerson; Anthony J. Calamunci; Nicole Hughes Waid; Amy L. Butler; Katy Wane (30 June 2017). "Pharmacist at Center of 2012 Fungal Meningitis Outbreak Sentenced to 9 Years in Prison". Fisher Broyles LLP. Retrieved 28 July 2017.
- ^ a b Raymond, Nate (December 13, 2018). "Jury convicts ex-employees of pharmacy in U.S. meningitis outbreak". U.S. Retrieved May 1, 2019.
- ^ Bentley, JD, Linda. "What Are Compounding Pharmacies?". WebMD. Retrieved 4 February 2020.