In September 2012, a case of fungal meningitis was reported to the Tennessee Department of Health. Within a week, Tennessee identified seven additional fungal meningitis patients, and discovered that they had all been treated at the same ambulatory surgical center. Each patient received an injection with a steroid product made at the New England Compounding Center (NECC), which voluntarily recalled three implicated lots of steroid injections on September 26, 2012. Soon thereafter, the originally isolated cases became part of an outbreak, with 751 cases in 20 states. The Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center, the FDA confirmed the presence of fungi in NECC steroid vials, and NECC expanded the recall to include all products distributed from its facility in Framingham, Massachusetts. NECC filed Chapter 11 bankruptcy in December 2012.
More than a year after the first fungal meningitis case was reported, the outbreak is continuing to affect its victims. A significant minority, 20 percent at one Michigan hospital, are still undergoing treatment for the disease and its complications. Some believed to be cured later suffered relapse, while others suffered permanent nerve damage or died after months of treatment. Over 600 victims have filed claims against NECC in connection with the outbreak. NECC’s problems are not limited to fungal meningitis—new lawsuits in Nevada allege that NECC’s drug cardioplegia caused severe infections following open-heart surgery that led to the deaths of two children, aged four and six.
The meningitis outbreak led to much higher scrutiny for drug compounding facilities. Drug compounding is a traditional component of pharmaceutical practice. It is the process by which a pharmacist combines, mixes, or alters ingredients to create a tailor-made drug to address an individual patient’s medical needs. Some pharmacies, such as NECC, compound large quantities of drugs in anticipation of future prescriptions. State pharmacy regulatory bodies are responsible for overseeing pharmaceutical practice. Drug compounding is described in laws and regulations for all 50 states, but specifics vary, as do resources to provide the necessary oversight. Members of Congress recently announced the bipartisan Drug Quality and Security Act, designed to clarify federal law regarding pharmacy compounding. Current federal law is a patchwork of regulations, resulting in inconsistent standards through the country and a circuit split among federal courts of appeals.
While waiting for a legislative solution to the problems facing oversight of compounding facilities, the FDA has continued to investigate the threats they pose to the public health. In early 2013, the agency identified and inspected 29 “priority inspection” compounding pharmacies. On October 22, 2013, the FDA issued the latest warning against and voluntary recall of certain human and veterinary products produced and distributed by the Specialty Medicine Compounding Pharmacy of Michigan after it discovered “floating particles” in the sterile drugs. As of October 31, 2013, the FDA has taken action against 58 compounding pharmacies.