FDA uses new method to detect counterfeit or sub-standard anti-malarial drugs

The U.S. Food and Drug Administration announced Wednesday that it will implement use of its Counterfeit Detection Device, called CD-3, against the prevalence of counterfeit or sub-standard anti-malarial drugs.

The CD-3 is a handheld, battery-operated device that uses light wavelength to compare unidentified products to their authentic counterpart to test authenticity. The device, developed by scientists at the FDA's Forensic Chemistry Center, is currently used to test cosmetics, foods, cigarettes and medical device authenticity. A new contract with Corning, however, has been signed to design a device that can screen products in bulk.

The FDA partnered with the Skoll Global Threats Fund, the U.S. Pharmacopeia, the National Institutes of Health, the Centers for Disease Control and Prevention and the multi-agency President's Malaria Initiative, led by the U.S. Agency for International Development, in support of an initiative to reach global control of malaria.

"Fake or substandard anti-malarial drugs cause double damage: without adequate, prompt treatment, the malaria parasite can kill a person in a matter of days, and inadequate treatment can also lead to the development of drug resistance, potentially rendering all treatment ineffective," FDA Commissioner Margaret A. Hamburg said. "The development of the CD-3 and the formation of this important partnership are critical steps toward the FDA's goal of improving the global product safety net in order to protect consumers in the U.S. and worldwide."

The new initiative will begin by optimizing testing on anti-malarial drugs to detect falsified products or vaccines that do not have an adequate amount of active ingredients, since this contributes to drug-resistance and can greatly increase risk of death due to infection. CD-3 efficacy testing will begin in Ghana this year and run through 2014 via the USP Promoting the Quality of Medicines Program; other partners of the initiative provide the funding to make these efforts possible.

Malaria kills over 660,000 people each year, mostly children from African and Southeast Asia. Making preventative methods available to these regions is critical in reaching global control of the disease, according to a study commissioned by the FDA.

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National Institutes of Health U.S. Agency for International Development

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