FDA will turn over its hand-held Counterfeit Detection Device to Corning Inc. for development into a mass-producable tool that can be used worldwide to identify counterfeit or substandard drugs.

Commissioner Margaret Hamburg April 24 announced the agency has signed a letter of intent for Corning to work on the device, which is in its third iteration (CD3), during a press briefing where she also unveiled a public/private partnership that will evaluate the device’s use for anti-malarial drugs in Ghana to gain field experience with it.

The CD3 “right now is an excellent prototype,” Paul Then, commercial technology director of advanced optics at Corning, told reporters. ”Our role in this will be to take what the FDA has done and turn it into a product that can be manufactured in volume in the future,” he said.

There currently are 50 CD3s; the devices examine a product with a variety of light wavelengths to provide a visual comparison of the product with an authentic sample Also see "FDA’s Hand-Held Rx Counterfeit Detector Could Roll Out To Developing Nations" - Pink Sheet, 25 March, 2013..

CD3 adds another component to FDA efforts to protect the domestic drug supply from counterfeits and adulteration. Congress currently is considering whether to write a federal track-and-trace system that would allow real-time tracing of a package’s route through commerce to determine if it came from a legitimate source, as preferred by FDA, or a lot-level tracking system preferred by some in the supply chain ([A#14130422008]).

FDA and Corning are still discussing details of their agreement, Hamburg said, but the company will have the opportunity “to build in the lessons learned from this initial testing stage in Ghana.”

Real-World Use With Malaria Drugs

That test will scan anti-malarial drugs at sites where U.S. Pharmacopeia’s Promoting the Quality of Medicines Program (PQM) currently collaborates with the Ghanaian Food and Drug Authority to conduct drug surveillance.

The project goal is to systematically put the technology out there and “see what it identifies and … have the chance to do the confirmatory work and really assess the reliability of this tool and get a much better sense of the realities of using this tool in the field,” Hamburg said.

ICD3’s ability to detect substandard drugs is of particular interest, she noted. “We know it can detect counterfeits. We know that the nature of the technology should enable us also to detect substandards, but we’re looking to really fully evaluate that.” Project managers will also be able to assess the best approach to training surveillance personnel on how to use CD3, she said.

PQM will test CD3 during 2013 and 2014 alongside existing screening technology used in Ghana to verify the authenticity of shipments of World Health Organization pre-qualified anti-malarial combination therapies – artemether/lumifantrine and artesunate/amodiaquine.

The partnership consists of the Skoll Global Threats Fund, which will finance the CD3 tests; the Centers for Disease Control and Prevention and the National Institutes of Health, which will provide technical support; the U.S. Agency for International Development and the President’s Malaria Initiative (PMI), which fund current PWM surveillance activities, as well as FDA and PDA.

Data from the test in Ghana will guide a second round of testing, which will occur at additional sites that are part of PQM.

FDA currently employs the CD3 in its laboratories and at a number of international mail facilities and other points of entry to the U.S. to screen cosmetics, foods, medical devices and cigarettes, as well as drugs.

An advantage to CD3 is that it offers multiple points of comparison between the suspect product and the authentic version, noted Leigh Verbois, acting assistant commissioner for compliance policy in the Office of Regulatory Affairs. This means counterfeiters will have to work harder and spend more money to duplicate an approved drug, she said.

Verbois did not provide the specifics of the ORA’s strategy for employing CD3 at the border, but FDA reported in August 2012 that it has fully deployed its PREDICT information technology system to identify high-risk imports for possible inspection Also see "High-Risk Drug Imports To Be Delayed, FDA PREDICTs; Focus On Data Quality Can Avoid New 20 Percent Dragnet" - Pink Sheet, 19 October, 2009..

FDA Counterfeit Screening Tool Gets Field Test In Ghana; Corning Prepares Device For Mass Production

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