FDA Creates Partnership to Battle Anti-Malaria Counterfeit Drugs

FDA has announced the deployment of an FDA-developed Counterfeit Detection Device (CD-3) as part of a public-private partnership to identify counterfeit or substandard anti-malarial medicines, including falsified products in Africa and parts of Southeast Asia. FDA has partnered 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). FDA also announced it has signed a letter of intent with Corning Incorporated to refine and improve the CD-3 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 A. Hamburg, M.D., in a press release. “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 Institute of Medicine reported 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, in the release. “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, developed by scientists at FDA’s Forensic Chemistry Center in Cincinnati, Ohio, 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, allowing inspectors to identify suspect products and remove them from the supply chain. According to FDA, 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, and information obtained from the test in Ghana will guide a second testing program.