FDA Has New Tool in Fight Against Counterfeit Malaria Drugs

Megan Brooks

April 24, 2013

The US Food and Drug Administration (FDA) today announced a public-private partnership to help spot counterfeit or substandard antimalarial medicines using a tool called the counterfeit detection device, or CD-3.

Developed by researchers in the FDA's Forensic Chemistry Center, in Cincinnati, Ohio, the CD-3 is a low-cost, hand-held, battery-operated tool that provides visual results in seconds, requires only limited training to operate, and can be used in remote locations.

"The device works by taking advantage of the fact that substances absorb light waves differently depending on their chemical makeup; so if you illuminate a counterfeit or substandard product it will look different from the authentic product," FDA Commissioner Margaret A. Hamburg, MD, explained during a briefing today.

Initiative "Clearly Imperative"

The partnership will focus on testing and optimizing the use of the CD-3 to identify counterfeit or substandard antimalarial medicines in Africa and parts of Southeast Asia, where the rates of malaria infection are high and where counterfeit antimalarial medicines are prevalent.

"In a recent review of 28 studies, 35% of antimalarial drugs in sub-Saharan Africa were substandard and 20% were counterfeit," Dr. Hamburg said. "The counterfeit problem is even worse in Southeast Asia, where more than 1 out of every 3 drugs were counterfeit."

"Given these trends, it's clearly imperative to identify counterfeit or substandard products before they are ever given to patients. Those are the marching orders of the public-private partnership I am announcing today," Dr. Hamburg said.

Partnering with the FDA on the initiative are Skoll Global Threats Fund, the United States Pharmacopeia, the National Institutes of Health, the Centers for Disease Control and Prevention, and the multiagency President's Malaria Initiative, led by the US Agency for International Development.

Larry Brilliant, president and CEO of Skoll Global Threats Fund, said, "We are very pleased to be a part of this public-private partnership. Skoll Global Threats Fund is very concerned about developing technologies for early detection and best responses to diseases that have pandemic potential. Malaria is certainly a disease like that.

"The ability to quickly ascertain in the field if a drug is authentic is important, not just in making sure our antimicrobial drugs are not counterfeit but also as an early innovation towards better overall public health," he added.

Frontline Tool

The CD-3 will first be tested in 2013 and 2014 in Ghana, a country with a high burden of malaria, with plans for further testing in other locations where malaria is prevalent.

The 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 for broader use.

"Counterfeiters don't limit themselves to antimalarial drugs," Dr. Hamburg noted. "Counterfeit and substandard drugs are a worldwide problem that we face in the United States as well. We've seen counterfeits for cancer drugs, cardiovascular medicines, and antidepressants to name just a few. Counterfeit drugs with little or no active ingredients can have devastating consequences."

Dr. Hamburg said that since 2010, the CD-3 has successfully identified counterfeit drugs and other unapproved products at US ports of entry. The tool has been applied effectively to screen cosmetics, foods, medical devices, and cigarettes and investigate product-tampering and questionable documents.

"We believe it has the potential to be a frontline tool in protecting the integrity of the global supply chain," Dr. Hamburg said.