Seeing Through the Murky Vial: Does the FDA Have the Authority to Stop Compounding Pharmacies from Pirate Manufacturing?

In late 2012 and early 2013, tainted steroid shots from the New England Compounding Center ( NECC ) caused fifty-five deaths and 745 cases of fungal meningitis in twenty states.\u27 On October 1, 2012, the Food and Drug Administration ( FDA ) inspected NECC and found vials of steroids filled with enough floating contamination to be visible to the human eye. These NECC steroid shots were distributed primarily to treat back pain, but the patients who received them were injected with foreign matter containing the deadly fungi Exserohilum rostratum or Aspergillus fumigatus. The earliest reported death from fungal meningitis caused by NECC was seventy-eight-year-old Kentucky Circuit Judge Eddie C. Lovelace. Judge Lovelace received three tainted steroid shots in July and August of 2012. In September, after experiencing confusion and dizziness, Judge Lovelace collapsed in his driveway on his way to pick up the morning paper. Fungal meningitis from the shots had spread to Judge Lovelace\u27s brain and caused a stroke. He passed away on September 17, 2012, just five days after the collapse. When such incidents of fungal meningitis became more widespread, the public and Congress demanded answers from the FDA regarding its oversight of compounding pharmacies. How could such a devastating outbreak occur on the FDA\u27s watch