MALARIA: FDA Hopes Tool Will Help Identify Substandard, Counterfeit Malaria Drugs in the Field

BY BRIDGET M. KUEHN ON APRIL 25, 2013

The US Food and Drug Administration’s Counterfeit Detection Device (CD-3) may help clinicians spot fake malaria drugs. Image: FDA

More than half of all drugs used to treat malaria in low- and middle-income countries are substandard or counterfeit, which contributes to preventable deaths and the emergence of drug resistance. But the US Food and Drug Administration (FDA) hopes that a battery-powered device it has used since 2010 may soon help frontline medical workers spot fakes before they reach patients.

Malaria was eliminated from the United States in the 1950s, yet it remains a scourge in many lower-income countries around the world. FDA Commissioner Margaret A. Hamburg, MD, noted at a press briefing held by the agency that each year, millions of individuals are sickened by malaria, and 660 000 die, mostly children. Effective drugs are available to treat malaria infections, but low- and middle-income countries are flooded with products that are counterfeit (20% of the malaria drug supply) or substandard (35% contain suboptimal levels of active ingredients). These fakes can have dire consequences for individual patients and for public health. In addition to preventing individuals from getting effective treatment, substandard drugs also contribute to the emergence of drug-resistant malaria parasites, Hamburg noted.

With the help of an array of public and private partners, the FDA hopes to test whether a tool created by scientists at the FDA’s Forensic Chemistry Center in Cincinnati, Ohio, may help clinicians battle fake drugs. The Counterfeit Detection Device (CD-3) works by shining different wavelengths of light on a product; the light reflects back in a pattern that varies based on the chemical make-up of the product. This pattern can be compared with reference samples of actual drugs, allowing the user to quickly distinguish a potential fake from the bona fide drug.

The FDA has used the CD-3 since 2010 to spot potential fakes among imported drugs, cosmetics, and other products before they are distributed in the United States, as well as in laboratory investigations of suspect products.

The FDA announced Wednesday that it is working with the Skoll Global Threats Fund, President’s Malaria Initiative, US Centers for Disease Control and Prevention, National Institutes of Health, and US Pharmacopeia to test whether the device will be effective in malaria-endemic areas. The testing will take place in Ghana in 2013 and 2014. The agency has also been working with Corning to develop a version of the product that can be manufactured for wider distribution.

Hamburg explained that the testing will help determine how sensitive and reliable this tool is in field conditions. She said the FDA has shown the device can distinguish a counterfeit from a real drug, but they want more information on how well the CD-3 can spot substandard drugs. The tests may also provide public health authorities with insights into the fake drug market.

“We will be learning more about the scope of the counterfeit and substandard drug market,” she said. “We don’t have as much information as we would like about the magnitude of the problem.”