It’s easy to focus on the aspects of GDP that control the complex journey from manufacturer to patient. But a recent US court case highlights the role GDP should play in protecting patients from counterfeit drugs.
Earlier this month, a Montana man, Paul Daniel Bottomley, was found guilty of failing to report the importing and mislabelling of unapproved drugs. In 2012, his company began selling a counterfeit version of Roche’s chemotherapy drug, Avastin, which amounted to little more than saline.
In 2008, Mr Bottomley founded Montana Health Care Solutions which, the FDA discovered, illegally imported misbranded and unapproved cancer drugs, selling them to US doctors by undercutting normal prices.
In 2012, the UK authorities alerted US officials that a shipment of fake Avastin was on its way to Canada Drugs’ distribution company.
In this case, it seems that almost the entire distribution chain may have been complicit in the fraud but in most cases the distributor has obligation to apply the principles of GDP to identify and quarantine suspected counterfeit drugs.
The quality of falsified goods varies, but it can be extremely hard to tell counterfeits apart from the original product. It is vitally important that personnel involved in distribution are aware of the risks of falsified goods entering the supply chain and are trained to look out for indicators that medicinal products may not be genuine.
Distributors should document the way they intend to achieve this awareness.
Typical ways of identifying counterfeit drugs include:
- Quality of the packaging, such as colour, printing, errors, omissions, thickness of card
- Smell, from non-standard storage facilities or materials
- Source, such as a new supplier or unusual route
- Price, including cheap deals that are “too good to be true”
- Availability, for example where large offers of normally hard to come by products are given
- Physical characteristics of the product, such as colour, embossing, particles, cloudiness
The FDA has not yet made it clear whether it intends to prosecute either Canada Drugs or the physicians who saved $600 per vial by purchasing the counterfeit Avastin. However, had the physicians followed the principles of GDP, they would have suspected the cheap price offered by a single supplier and protected their patients.
The judge decided against a custodial sentence, in light of Mr Bottomley’s cooperation and after he sent a letter highlighting the fact that he would not be able to support his wife and two daughters if imprisoned. He also wrote, “we have surrendered everything we have to the Federal Government except our home and are now in a position of considerable debt."
If all involved had followed the principles of GDP, not only would an as yet unknown number of cancer patients have received proper treatment but Mr Bottomley might even have managed to keep the 2011 Aston Martin, $3 million in land, and $1 million in cash he had to surrender.
We appreciate your interest in this blog and would really like to know your views. Is this entry bang on the nail or widely off topic? What is your experience of checking for counterfeit drugs? Do the GDP guidelines go far enough? Should regulators do more to control the trade or should responsibility lie with importers and distributors? Please leave any of your questions or comments below. We’ll review and comment regularly.
