FDA Launches Partnership

FDA has established a public-private partnership to help identify counterfeit or substandard anti-malarial medicines including falsified products by deploying the FDA-developed Counterfeit Detection Device (CD-3).

Malaria kills more than 660,000 people globally each year, mostly children. The threat of drug resistance, limited availability of medications, and the increased distribution of counterfeit or substandard anti-malarial medicine pose significant challenges to treating the disease. The new partnership will focus on testing and optimizing the use of the handheld CD-3 to use in Africa and parts of Southeast Asia where the rates of malaria infection are high and where counterfeit anti-malarial medicines are prevalent. Minimal scientific or technical background is needed to operate the tool but it needs to be used in remote communities or in places with only very basic healthcare systems.

The CD-3 operates as a handheld battery operated tool illuminating a product with a variety of wavelengths of light able to do a visual comparison of an unverified product with an authentic sample. This enables inspectors to identify suspect products and remove them from the supply chain

To establish the use of the CD-3 tool further, FDA has established a partnership with the Skoll Global Threats Fund, the U.S. Pharmacopeia (USP), NIH, CDC, and the multi-agency President’s Malaria Initiative (PMI) led by USAID. FDA has also announced that a Letter of Intent has been signed with Corning Inc. to refine and improve the tool for eventual manufacture on a larger scale. 

The tool will be test counterfeit or substandard versions of two common anti-malarial therapies in Ghana in 2013 and 2014. The USP Promoting the Quality of Medicines Program (PQM) with funds from USAID and PMI will collaborate with the Ghanaian Food and Drug Authority to conduct drug surveillance programs at test sites in Ghana. The partnership with CDC and NIH will provide technical support and the Skoll Global Threats Fund will provide additional funding for the initial testing program in Ghana.

 Also, for the past three years, the tool has been used at U.S. ports of entry and elsewhere by FDA investigators to check suspect products and FDA has found CD-3 to be helpful for discovering product tampering and for checking questionable documents.

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