Federal Inspectors Face Difficulties Investigating Fungal Meningitis Outbreak

An outbreak of fungal meningitis, which began last year and has been traced back to a compounding pharmacy in Massachusetts, has killed more than 50 people in 20 states and affected nearly 700 others (according to the Centers for Disease Control and Prevention). This company, called the New England Compounding Center (NECC), created custom medications for clients in several states. The tainted drug in question was a steroid compound called methylprednisone acetate, commonly prescribed for chronic back pain. The New York Times estimates that about five million Americans take this drug every year, and that the NECC shipped about 17,000 vials of it to medical professionals across the country, most of whom are involved in pain management centers.

Fungal meningitis is an infection of the membranes covering the brain and spinal cord, which are called the meninges. In this illness, the meninges are tainted when invasive fungus begins to grow and multiply in cerebrospinal fluid. Those who were treated with the tainted medicine have suffered stroke, central nervous system infections and joint infections (knees, hips, shoulders and/or elbows). Other symptoms include fever, headache, nausea and vomiting, sensitivity to light, slurred speech and altered mental states like confusion. In addition to these ailments, many patients are complaining of an infection near the injection site, known as an epidural abscess.

We have published two blogs posts on the matter; the first one is titled “Fungal Meningitis Linked to Tainted Steroid Injections,” which outlines some of the facts as they were available in January of this year. A second, “More Compounding Pharmacies Shut Down in Fungal Meningitis Scare,” explains that the state of Massachusetts conducted unannounced inspections of about 40 similar businesses to ensure that they have been maintaining sterile workplaces. As of mid-February, the Massachusetts Department of Public Health had ordered the partial or complete closure of 11 such companies due to substandard practices. The FDA has classified 31 of these facilities “high risk.” The Associated Press reports that as of December of 2012, 50 lawsuits were filed in nine states, and that number has surely increased in the months since.

Since then, Commissioner of the FDA Margaret Hamburg has written that inspectors noticed in several facilities “unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in ‘clean rooms’ where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats.”

Hamburg continues, “[S]ome of the firms we inspect still challenge our authority to conduct full inspections of their facilities. Our inspections have been delayed or the inspectors were denied full access to records at some of these facilities. At least four of our recent inspections were delayed by such resistance; and in two other instances, we had to get administrative warrants from the courts […] These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health.”

Compounding pharmacies have faced criticism for being what many view as a means of distributing drugs outside the purview of the FDA, and many in turn see the FDA is failing in its duty to effectively protect American consumers. This may result in any manner of injury or illness related to taking dangerous or defective drugs.