FDA goes its own way with counterfeit detection device

The US FDA has developed its own handheld counterfeit medicines detector that can be deployed at a much lower cost compared to commercially-available devices.

The Counterfeit Detection Device 3 (CD3) is designed to be used in the field to detect counterfeit products, ingredients and packaging, and is already being deployed by the FDA across the US, with work on a fourth-generation device already in progress.

The agency has been putting a number of commercial scanner devices through their paces in recent years, particularly handheld Raman and FT-IR spectrometers which have also been deployed for use by US Customs and Border Protection (CBP) personnel.

These tend to be expensive and generally incorporate a single scanning technology, however, so the agency decided to build its own low-cost unit - with a price tag of around $1,000 - that could use several different scanning systems in a single unit.

"This device was designed in-house by FDA scientists in response to the needs for screening in the field," said FDA Commissioner Dr. Margaret Hamburg. "It is low cost compared to other analytical devices, operates with batteries, and requires minimal training to use."

It uses 10 different wavelengths of visible and invisible light - from ultraviolet to infrared - and has been road-tested on almost 100 different pharmaceutical products at risk of counterfeiting.

These include erectile dysfunction products like Pfizer's Viagra (sildenafil) and cholesterol-lowerer Lipitor (atorvastatin), opioid painkillers such as Purdue Pharma's Oxycontin (oxycodone) and Merck & Co's asthma treatment Singulair (montelukast).

Counterfeits and products that have been tampered with - for example re-labelled or re-glued - exhibit unusual colours or shades on scanning.

The CD3 also allows for 'real time' comparisons with authentic drugs, added Hamburg, noting it has already proven useful for "identifying counterfeit drugs at our busy international mail facilities."

In the last decade, the number of FDA-regulated products entering the country has quadrupled from about 6 million a year to more than 24 million a year, she said.

The CD3 has already been rolled out to 50 of the agency's field laboratories, as well as border crossings, mail-sorting offices and importation points.