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.

The CD-3 is a battery-operated, hand-held and inexpensive tool that costs a fraction of the price of existing laboratory-based and field-deployable technologies. Image courtesy of the FDA

“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 A. Hamburg, M.D. “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 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 programs at test sites in Ghana, and the new partnership will leverage this existing infrastructure. CDC and NIH will provide technical support, and The Skoll Global Threats Fund will provide additional funding for the initial testing program in Ghana.

Information obtained from the test in Ghana is intended to guide a second testing program, which will also make use of existing infrastructure from the PQM program.

In a recent report3 commissioned by the FDA, the Institute of Medicine 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 proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected,” said Commissioner 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.”

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 very basic health care systems.

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 mail facilities in the United States 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.