The device will be tested in Ghana this year and in 2014
The US Food and Drug Administration aims to identify counterfeit or substandard anti-malarial medicines with the introduction of a detection device called CD-3.
The FDA has established a partnership with the Skoll Global Threats Fund, the US 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 US Agency for International Development (USAID), to test and optimise the use of this device in Africa and parts of Southeast Asia, where the rates of malaria infection are high and where counterfeit anti-malarial medicines are prevalent.
The FDA has also signed a letter of intent with Corning to refine and improve the tool for eventual manufacture on a larger scale.
‘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,’ said FDA Commissioner Margaret Hamburg. ‘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 US and worldwide.’
The CD-3 is a handheld, battery-operated tool that illuminates a product with a variety of wavelengths of light to provide a visual comparison of an unverified product with an authentic sample. This allows inspectors to identify suspect products and remove them from the supply chain. Minimal scientific or technical background is needed to operate the tool, and it can be used even in remote communities or in places with only basic healthcare systems.
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
Scientists at the FDA’s Forensic Chemistry Center in Cincinnati, Ohio, developed the tool, which has been in use since 2010 in their laboratory as well as in a number of international postal facilities in the US and other points of entry where investigators screen drug ingredients and other finished products to identify counterfeit or unapproved products. The tool has also been applied effectively to screen cosmetics, foods, medical devices, and cigarettes, and investigate product tampering and questionable documents.
The effectiveness of the tool in detecting counterfeit or substandard versions of two common anti-malarial therapies will be tested in Ghana in 2013 and 2014. The USP Promoting the Quality of Medicines Program (PQM), with funds from USAID and PMI, collaborates with the Ghanaian Food and Drug Authority to conduct drug surveillance projects at test sites in Ghana, and the new partnership will leverage this infrastructure. CDC and NIH will provide technical support, and The Skoll Global Threats Fund will provide additional funding for the initial testing programme in Ghana.
Data gained from this test in Ghana will guide a second testing programme.
‘The proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected,’ said 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.’