Today, we announced a partnership with the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, the United States Pharmacopeial Convention (USP) and Corning to assess the utility and effectiveness of a new counterfeit detection device (CD-3) developed by the FDA to detect counterfeit medicines in the field. The USP Promoting the Quality of Medicines Program, with funds from USAID and the President’s Malaria Initiative, collaborates with the Ghanaian Food and Drug Authority to conduct drug surveillance programs at test sites in Ghana, and the new partnership will leverage this existing infrastructure to allow immediate testing of CD-3 in an area where malaria is endemic.
The FDA’s CD-3, already deployed for drug authentication in the U.S., is designed to work under real-world conditions for drugs in developing countries. The CD-3 device is based on sample illumination at specific wavelengths of light and visual comparison to a standard. It is a non-destructive, rapid, portable device that requires little training for effective use. The study in Ghana will allow for understanding of the capability of the CD-3 to discriminate between authentic and falsified medicines in the field in real time. For the Skoll Global Threats Fund, we are testing the implementation of a technology that, if successful, will be in line for implementation at scale in other endemic malaria regions as well, including South East Asia.
We’re testing this out with malaria first as the real world crisis of counterfeit and substandard drugs threatens global health efforts to combat this illness. But we hope the technology can be proven effective for other drugs and other uses as well. It will help prevent ineffective or detrimental interventions on known diseases, such as malaria. But it could prove particularly useful in cases of sudden epidemic outbreaks, where desperate people could provide a ready market for unprincipled opportunists willing to sell fake drugs. At a higher level, we see the ability to take these types of technologies effectively into the field as critical for tackling global health threats from infectious diseases. The ability to scan a medication is not too different technologically than the ability to scan, say, a blood or sputum sample for telltale signs of disease in a point of care diagnostic platform.This is what makes the CD-3 particularly interesting to us, because it can serve as a proof of concept of what might be possible for point of care diagnostic tools going forward.