FDA to trial counterfeit detector via public-private alliance

The US Food and Drug Administration has made its in-house developed counterfeit detection device (CD-3) available for field trials in a new project to tackle counterfeit antimalarial drugs.

The agency has also said it will work with laboratory instrumentation specialist Corning to develop an improved version of the handheld detector that will be suitable for large-scale manufacture.

FDA officials hinted last year that the device, which illuminates a medicine sample with various wavelengths of light to provide spectra that can be used to distinguish genuine from fake products - would be made available to other organisations. It is already being deployed for use by federal staff at mail-handling centres and border points in the US.

One of its key advantages is expected to be a low cost of implementation compared to other commercial handheld detectors, with the FDA saying recently that the cost of components for CD-3 was around $1,000 per unit, not including assembly charges. Other scanners can cost tens of thousands of dollars per unit.

In a recent report commissioned by the FDA, the Institute of Medicine (IoM) concluded that making detection technology more accessible to low and middle income countries would be invaluable in controlling the trade in counterfeit, falsified, or substandard medicines.

The public private partnership – formed with the Skoll Global Threats Fund, the US Pharmacopeia (USP), US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), and the multi-agency President’s Malaria Initiative (PMI) – is being led by the US Agency for International Development (USAID) and will focusing on testing an optimising the use of the CD-3 device to screen for fake or substandard malaria drugs in Africa and southeast Asia.

Malaria kills more than 660,000 people each year, mostly children, thanks largely to a lack of access to treatment and exposure to medicines with inadequate potency which in turn stimulate resistance in malaria parasites, says the regulator.

FDA plans to carry out field testing of the CD-3 detector in Ghana later in 2013 and in 2014 in collaboration with the USP’s Promoting the Quality of Medicines (PQM) programme and with funding from USAID and PMI.

The CDC and NIH will provide technical support, while Skoll is making additional funding available for the initial testing program in Ghana.

"The proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected," said FDA Commissioner Margaret Hamburg. 

"The FDA is pleased that CD-3 has the potential to be used as a frontline tool in protecting the global supply chain and make a positive impact on public health efforts to combat malaria in developing regions of the world that are particularly hard hit by the disease."