To minimize patient exposure to the public health threat, the FDA has established a partnership with the Skoll Global Threats Fund, the U.S. Pharmacopeia, the National Institutes of Health, the Centers for Disease Control and Prevention, and the multiagency President's Malaria Initiative, led by the U.S. Agency for International Development.
Dr. Margaret A. Hamburg, commissioner of the FDA, said the partnership would focus on testing and optimizing the use of the handheld FDA-developed Counterfeit Detection Device -- known as 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.
Hamburg announced the FDA signed a letter of intent with Corning Inc. 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," Hamburg said in a statement. "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."