When the Justice Department issued its 131-count indictment against the now-defunct New England Compounding Center, it accused the compounding pharmacy of working on the scale of a drug manufacturer rather than a compounding pharmacy which is required to fill individual prescriptions. Among the evidence that may surface if the case goes to trial is that NECC ignored that requirement, filling prescriptions with names on them that included Big Baby Jesus, Silver Surfer, Filet O'Fish and Coco Puff.
In fact, according to a deep look by Newsweek, the company scrambled to get names associated with prescriptions after selling bulk drugs for three years without bothering with the requirement. And when NECC finally insisted that clients around the country provide them, they got the joke names back in many cases but filled the orders just the same.
That is only one of the shortcuts allegedly taken by NECC whose contaminated drugs were tied to a nationwide fungal meningitis outbreak in 2012 that infected 750 people, of which 64 would die. A 73-page indictment was unsealed in December, charging 14 people with a variety of crimes. Those include 25 murder charges against two lead pharmacists, a move that will not go unnoticed throughout the entire pharma industry. The feds said NECC reaped millions of dollars by cutting corners in the manufacture of what were supposed to be sterile drugs not only by falsifying records but also by using expired ingredients, shortchanging sterility steps and lying to clients about the drugs' safety.
Among other accusations is that NECC put its drugs at risk for contamination by reducing the time that they were in an autoclave for sterilization from 20 minutes to about 15. Over an 8-hour day, the shorter sterilization time allowed the company to produce a couple more batches of drugs a day, Newsweek reports. And it was producing those batches in a facility that authorities found to be filthy. The clean room had powder hoods clogged with dirt, a boiler standing in a pool of stagnant water and air intakes units that were about 100 feet away from a recycling plant.
It also was barely testing the drugs for sterility once they were produced. Vials from the batch of injectable steroids believed to have led to the fungal meningitis infections was tested once, not twice as required, and only a tiny sample was taken, the magazine reports.
The outbreak was a wake-up call for the FDA, which began a crash campaign to inspect all of the largest compounders in the country. It led to a law that gave the FDA more authority over the traditionally state-regulated industry. That in turn has led to a number of legal actions. Last month a federal judge issued a permanent injunction against Texas-based Specialty Compounding, whose contaminated drugs gave bacterial bloodstream infections to 17 patients in 2013. In February federal authorities indicted New Jersey-based Med Prep Consulting, its owner and pharmacist-in-charge on 37 counts that accuse them of intentionally defrauding the FDA and hospitals by making drugs in less than sterile conditions.
- read the Newsweek article