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The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.
Malaria kills more than 660,000 people globally each year, mostly children. The threat of drug resistance, limited availability of medication, and increased distribution of counterfeit or substandard anti-malarial medicines pose significant challenges to treating this disease. Compromised anti-malarial medicines often have too little or no active ingredients, preventing adequate and timely treatment. Anti-malarial medicines made with reduced dosages of active ingredients will not cure patients with malaria, and they can lead to resistant strains of the parasite, making it tougher to treat malaria, even with authentic medicines.
To minimize patient exposure to this public health threat, the FDA has established a partnership with the Skoll Global Threats Fund, the U.S. Pharmacopeia (USP), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the multi-agency President’s Malaria Initiative (PMI), led by the U.S. Agency for International Development (USAID).
The partnership will focus on testing and optimizing the use of the handheld CD-3 to identify counterfeit or substandard anti-malarial medicines, including falsified products, in Africa and parts of Southeast Asia, where the rates of malaria infection are high and where counterfeit anti-malarial medicines are prevalent.
FDA also announced today it has signed a letter of intent with Corning Incorporated to refine and improve the tool for eventual manufacture on a larger scale.