Twelve dead, and counting. The case of contaminated steroid injections demonstrates the potential for serious harm posed by regulatory and oversight gaps in the nation’s pharmaceutical industry. As it should, an outbreak of fungal meningitis, traced to medication produced by a Massachussetts pharmacy, the New England Compounding Center, is prompting calls to review the patchwork of federal and state regulations that leaves independent, specialty pharmacies with little oversight.
Thousands of independent pharmacies combine or “compound” drug ingredients to meet specific medication and dosage needs of local doctors and patients. Mostly, they are small operators. But compounding pharmacies such as the NECC are growing and taking advantage of drug shortages and the steep prices of major drug manufacturers to produce large quantities of medications for market. The problem is, drug manufacturers are regulated by the federal Food and Drug Administration, conduct clinical trials and must document the safety of their products. Compounding pharmacies, under the purview of state pharmacy boards, in effect, mimic manufacturers, but with much less stringent regulation and oversight.
Fungus-tainted injection vials from NECC were shipped to 23 states. Some 13,000 patients likely received the medication to treat back and joint pain. With 124 meningitis infections confirmed and a dozen deaths so far, including one in Ohio, the question is how quickly to close the oversight gap.