A ground-breaking handheld counterfeit detection device created by FDA’s Forensic Chemistry Center will be deployed in Ghana over the next few years to help in that region’s battle against counterfeit and substandard anti-malaria medicines. This relatively inexpensive device, known as CD-3, has enormous potential to protect patients from the ravages of these insidious drugs, ease human suffering and save lives. Congratulations to the scientists at FCC who developed it and to FDA for spearheading this worthy effort.
However, FDA should also be developing innovative applications for CD-3 in this country. Just within the last year, we have seen several alarming examples that our supply chain is vulnerable. From counterfeit oncology drugs, to fraudulent Botox with counterfeit packaging, and massive schemes to launder diverted drugs back into the supply chain, patients everywhere are at risk like never before. Unfortunately, only one sentence in the FDA announcement described how CD-3 is being used domestically, and it is pretty weak, especially considering the enormous potential of this device. According to FDA, “Since 2010, the tools have been used in some U.S. ports and mail centers, where drugs entering the county after being bought over the Internet represent a major problem.”
With the assistance of state regulators, FDA could develop a pilot study utilizing CD-3 to survey certain high-risk drug products at medical clinics, pharmacies and wholesalers. This would likely provide valuable insights into the security of our supply chain and help to guide future initiatives in this area.