Producing Safe Medicines is both Difficult and Important
I am deepely saddened by the loss of life, and pain and suffering of survivors and loved ones effected by The New Engalnd Compounding Company. Dozens of patients have been killed and hundreds afflicted with Menigitis by taking pharmaceutical products from NECC. The life Science Industry was also struck a blow.
What’s the lesson learned, it would be a shame not to learn something. The Supply Chain and Manufacturing Practices for Pharmaceuticals actually matters and it is hard. It is common sense that any therapeutic, be it medicinal, device, oral, injectable, whatever, needs to comply to rigid manufacturing and distribution standards. This consistency and dependability needs to be in place in order to ensure predictable outcomes and efficacy and, of course, safety. There are so few significant safety incidents attributed Life Science companies’ manufacturing practices that when incidents happen it is headline news.
Along the same lines, it is easy to look at regulatory agencies like the FDA or EMA as being bureaucracies put in place to simply monitor unnecessarily stringent rules and obscure, subjective guidance around the very regulations that give rise to the agency itself. Perhaps the cost of complying with these regulatory agencies makes it attractive to find a loophole to avoid them altogether, irrespective of legality and potential impact on society. That said the drug supply is amazingly safe, I think these agencies deserve some of the credit as well.
What happens when loopholes are found and exploited? The New England Compounding Center happens; now here’s an horrific example of where a company has clearly transcended the law and just plain went off the rails. Pharmaceutical Compounding has been around as long as the practice as medicine and pharmacology itself. I have relatives in the compounding business; they take in scripts from physicians, manufacture the product indicated in the script and deliver it safely and with an impeccable record of safety and reliability. They market themselves as Pharmaceutical Compounders, highly skilled service providers; they do NOT market the products themselves. The FDA has the right to inspect the facility and credentials of the staff, however, the FDA typically leave this to the Board of Registration in Pharmacy in their state.
Life Sciences would appear to be a self-regulating industry in a sense: Make reliable, clean product and the business will thrive. Produce inferior, tainted product and you kill, sicken and scare your patients and will likely face bankruptcy and criminal action. The New England Compounding Center is more than likely going to cease to exist, which is probably appropriate, sadly, that also leaves those with legal cases against them in limbo when they attempt to recover losses and compensation for same.
In the end, I think this atrocity exemplifies the power and ingenuity of Pharma and Med Device companies in the manufacture of reliable, effective and consistent products of long periods of time, the exception proves the rule. Compliance with regulatory agencies underlies a small part of this capability. The larger driver is to improve health globally, care for the ill, and serve patients and shareholders responsibly.
If incidents happen, and they will, our companies have invested enormous amounts of intellect and capital to ensure reliable, rapid and complete recall of all effected products, including traceability to the batch excipient and API level regardless of point of origin. The supply chain may not be glamorous, but it certainly matters.