The US Food and Drug Administration has a tough job. The burden of ensuring the safety of consumers and patients requires them to review large dossiers of data for new molecules prior to granting approval for marketing. They must assess novel pharmacology and gauge the likelihood of hitherto unseen drug interactions. One way that FDA cuts the workload is by allowing manufacturers to use some well-known ingredients without seeking reapproval. The list of ingredients which are “GRAS” or Generally Recognized As Safe allows collective knowledge and data to be taken as read, saving time and money for all concerned.
It occurred to me last week during the counterfeit Avastin story that we should develop an analogous but reverse logic for supply chain processes. My proposed list of “GRAU” or “Generally Recognized As Unsafe” practices would be a guide to collective wisdom on how to avoid an insecure supply chain. I’m talking about things which aren’t technically illegal but are either pretty unwise or straight reckless. Happily, the acronym is also the German word for grey (or “gray” for US readers) which allows me to segue to point number one on my list: grey market procurement:
Many cases of harm being caused by diverted and counterfeit medications boil down to people seeking to save a buck by buying outside the regulated sales channels. As Adam Fein and others have noted, the Avastin incident would not have occurred if the drugs had been bought from standard US distributors. Anyone who still thinks that buying drugs by blindly focusing on price alone is a good idea should read “Dangerous Doses” by Katherine Eban. In fact, just read it anyway.
One of our other surprisingly common findings is: returns processing without safeguards:
If someone can return your product and receive a refund with no questions asked then you are opening the door to fraud and counterfeiting. It may seem obvious, but the authenticity of all returns should be checked before payment is made. Some companies outsource returns processing – are your service providers doing the necessary due diligence?
These are just two recurring themes that shouldn’t be allowed to recur any longer. There are dozens of other unsafe processes that we come across in our work at Blue Sphere Health. Some of them are covered in my book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. Others are confidential to customers (and have now been fixed).
Anti-counterfeiting requires attention to processes - security technology does not compensate for poor business practices. If you need an independent audit of your product security processes then contact me confidentially at mark(dot)davison(at)bluespherehealth(dot)com or use the Contact form. Feel free to add your own public domain GRAU ideas in a comment below (or send to FDA).
Photo: www.failblog.org (the site is a good way to fill a coffee break if you like the absurb side of life)
{ 0 comments }