It appears that the recent outbreak was caused by the collective failure of Massachusetts state health regulators and the FDA to recognize and halt a pattern of fraudulent and misleading activity at the company that manufactured the steroid cocktail responsible for the meningitis outbreak. Known as New England Compounding Center, the company may have been engaging in unsafe practices for a decade or more before the outbreak occurred. While both the FDA and the Massachusetts Pharmacy Board seemed to have been aware of systematic health violations at NECC’s main facility in Framingham, Massachusetts, neither took meaningful steps to correct the problem.
This seemingly unconscionable lack of oversight and accountability occurred partially by design. NECC was founded as as a compounding facility that existed to produce custom mixtures of prescription drugs on demand. The company was licensed as such and never cleared by any health regulators to operate as a direct-to-retail manufacturer of original drugs. The state and federal laws that govern the operation of compounding facilities are considerably more lax than those that govern the operation of pharmaceutical companies and drug manufacturers.
Unfortunately, it appears that NECC was operating as a de facto drug manufacturer. The company maintained agreements with doctors, hospitals and retailers in nearly every state and would regularly produce generic knockoffs of existing drugs and vaccines. It would also regularly produce made-to-order steroid mixtures like the batch that caused the outbreak.
Although the enormous scale on which this particular company distributed its products may have been unusual, many other compounding facilities continue to blur the line between custom compounding and wholesale manufacturing and distribution. In fact, a recent investigative report by NBC News found that over 7,000 compounding facilities regularly make mixtures of steroids and other drugs. About 3,000 adhere to sterile processing protocols designed to minimize the risk of the sort of cross-contamination that caused the NECC outbreak.
The FDA and the various state health regulators are now racing to come up with a framework for recognizing and punishing lapses in the production and sterilization processes used by these outfits. Since NECC was cited several times during the run-up to the outbreak without ever being ordered to halt its operations, it’s clear that regulators must put in place a stricter regime that immediately identifies and isolates problematic procedures. The task at hand is an urgent one: Every year, dozens of compounding facilities are cited by local health authorities for lapses resembling those that occurred at NECC.
It’s unclear whether regulators can update the safety protocols designed to prevent tainted drugs from reaching the market in time to prevent another outbreak. Bacteria, fungi and viruses suspended in improperly-sterilized compounds can continue to grow and avoid detection for long periods of time. It may ultimately fall to the FDA and other agencies to combine more sensitive testing procedures with more aggressive inspection schedules. Even so, this fungal meningitis debacle serves as a sobering reminder that medicine is an imperfect science.
Jesse Anderson has worked in the medical field, and knows how dangerous fungus and bacteria contamination can be for patients. If you believe that you have been infected by meningitis, seek help from a certified personal injury lawyer specializing in meningitis.