Regulatory Focus™ > News Articles > New Device Aims to Secure Domestic, Foreign Supply Chain by Identifying Counterfeits

New Device Aims to Secure Domestic, Foreign Supply Chain by Identifying Counterfeits

Posted 26 April 2013 | By Alexander Gaffney, RAC

A new tool unveiled Thursday by US regulators on the eve of world malaria day promises to assist global public health officials with the detection and removal of counterfeit anti-malarial drugs, the likes of which now contribute to a budding public health crisis.

Basics: The CD-3

The device, known as the Counterfeit Detection Device v.3 (CD-3), was developed by the US Food and Drug Administration (FDA) with support from the Skoll Global Threats Fund, the US Pharmacopeial Convention (USP), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the President's Malaria Initiative (PMI).

The device, which has the appearance of a particularly bulky TV remote control with a small screen, emits 10 different visible wavelengths of light which are used to compare an authentic control product with the suspect anti-malarial product.

The device isn't designed to determine the exact problem affecting a drug, explained Duane Satzger, director of FDA's Forensic Chemistry Center, in an interview with MedPage Todayin September 2012. "It just lets you know there is one."

And that could be all the firepower that foreign public health officials need to prevent counterfeit anti-malarials from proliferating in the market. It is thought that malaria kills approximately 660,000 people each year, the majority of whom are children.

Given the huge number of people affected by the disease, there is a vibrant market for counterfeit and substandard products, both of which can potentially cause problems.  Counterfeit products may contain no active ingredient, the incorrect active ingredient, or substandard ingredients. Substandard products may not have been appropriately manufactured and might not have the desired effect.

"Substandard and counterfeit medicines for diseases including malaria, tuberculosis and HIV/AIDS pose a dire public health threat to patients in developing countries, in particular children and pregnant women," USP explained in an August 2012 statement. "Such medicines can exacerbate the course of these diseases, even leading to death, as well as contribute to the growth of drug-resistant disease parasites-threatening the viability of treatments for patients worldwide."

Some countries, such as Guyana, have more counterfeit and substandard medicines than high-quality and genuine ones, according to USP data.

As of last year, FDA and USP had already deployed dozens of the CD-3 devices into domestic mail facilities for testing, but had noted that the device was still very much in the "proof of concept" stage of development.

Other Uses Focus on US

Now that development process is moving into more advanced stages, with FDA announcing a new development partnership with Corning Incorporated to "refine and improve the [CD-3] tool for eventual manufacture on a larger scale."

"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," Margaret Hamburg, commissioner of FDA, said in a statement. "The proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected. 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."

FDA added that the tool also has applications for screening and testing cosmetics, foods, and medical devices, as well as determining whether a product has been tampered with or if supporting documents have been forged.

In other words, expect to see the CD-3 device soon as many import and export facilities.

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