FRIDAY, SEPTEMBER 30, 2016

FDA launches partnership to protect against counterfeit anti-malarials

The U.S. Food and Drug Administration announced a public-private partnership on Wednesday to help identify substandard or counterfeit anti-malarial medicines with the deployment of the Counterfeit Detection Device.

Counterfeit or substandard anti-malarial drugs can prevent adequate and timely treatment of the deadly disease and can result in resistant strains of the malaria parasite. The FDA established the partnership to test and optimize the CD-3 to identify the counterfeit medicines in Africa and parts of Southeast Asia where counterfeit anti-malarials are prevalent.

"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," Margaret Hamburg, the FDA commissioner, said. "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 FDA will test the effectiveness of the tool in Ghana in 2013 and 2014. Information from the test will guide a second testing program.

"The proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected," Hamburg said. "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 handheld, battery-operated CD-3 tool was developed by scientists at the FDA's Forensic Chemistry Center in Cincinnati. The tool has been applied effectively to screen cigarettes, medical devices, foods, cosmetics and to investigate questionable documents and product tampering.

The partners in the project include the President's Malaria Initiative, the Centers for Disease Control and Prevention, the National Institutes of Health, the U.S. Pharmacopeia and the Skoll Global threats Fund.

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