FDA’s Own Device Reveal

FDA unveils a device of its own creation – one meant to rapidly screen for counterfeit drugs.

The iPhone 5 may have been the most anticipated device unveiled last week but FDA introduced its own small (ok, 6” x 3”) black box two days earlier.

FDA Commissioner Margaret Hamburg highlighted the counterfeit drug identification device, CD3 (Counterfeit Detection 3) at FDA’s Science Writers Symposium on Sept. 10. She was joined by director of FDA’s Cincinnati-based Forensic Chemistry Center, R.D. Satzger, and the Forensic Chemistry Center’s Nicola Ranieri, the CD3’s inventor.

The CD3 (which, Hamburg admits, may need a “slightly more compelling” name) was designed in-house by FDA scientists. Satzger said those in the FCC lab actually manufactured the 50 devices in circulation throughout the FDA – they typically don’t do that kind of work. Hamburg said the U.S. patent was filed in March 2009.

The device was inspired by tools on shows like CSI.  Samples are lit up by specific single wavelengths of light – the paints, inks, dyes, chemical components of the rug or paper sample can emit light at different wavelengths.  These are compared to a control drug in real time – either in on the same table or, if you don’t want to carry the authentic drugs around, compared to an image of the authentic product under the wavelength stored on the devices 4mg of data storage.

The idea is you get visual difference that shows a different surface response to the wavelength of light – they don’t tell you the problem, but let you know to send the product to a lab for more evaluation. Hamburg said they hope to push the evaluation process further into the field over time as well.

It’s been tested to identify counterfeit drugs at international mail facilities, and the goal is for a device that’s battery-operated, low cost (~$1000 for the current iteration) and requiring minimal training.

Ranieri demonstrated the device using boxes of Sudafed, alli labels, and Zyprexa and Plavix pills.  It can also tell when liquids have been diluted.

Hamburg said there are potential broad applications for use in settings outside the FDA (including counterfeit/adulterated documentation) but that the agency is working on testing/strengthening the tool for its own use in the meantime. Satzger said FDA is working with NIH’s Office of Technology Transfer – that would be the process for greater use. (The agency is also interested in distributing it to developing countries eventually.)

One of the more interesting ideas: working with manufacturers to add certain markers to products in advance – something FDA can then check for on a certain wavelength, but that the would-be counterfeiters won’t know what to look for.

The CD3 hasn’t yet been fully evaluated to address drugs with inactive ingredient levels, improperly stored drugs, or those repackaged after their expiration dates.

But it’s a good example of FDA’s tools and risk-based approaches (remember PREDICT?) And it’s worth noting, after FDASIA passed with no track-and-trace/pedigree legislation, that FDA pointed out this device would have shown the difference between the real and counterfeit Avastin labels earlier this year.