FDA to create database to help identify counterfeit pharmaceutical brands

Reproduced with kind permission (NOVIS) Copyright - all contents of this article © 2000/2004– NOVIS. – All Rights Reserved.May 3 2004

The US Food and Drug Administration (FDA) is planning to create a database of the major pharmaceutical brands on the US market, to make it easier to establish the authenticity of suspect products and identify counterfeit versions that enter the supply chain.

The agency’s Cincinnati-based Forensic Chemistry Centre (FCC) will establish a Counterfeit Analysis Work Group that will compile and maintain the database, which will contain frequently-updated information on both authentic brands and counterfeit versions of drugs.

The group will put together a checklist that will be sent to all pharmaceutical companies selling products in the US, requiring them to provide the FCC with certain information about their brands to help ensure their authenticity. It will also create a database of authentic dosage forms for drugs.

Given the size of the undertaking, it has been suggested that not every drug will be included on the database. The FCC is initially asking pharmaceutical firms submit the requested information for their top five best-selling drugs, or for those that they believe to be most at risk of counterfeiting.

It is expected that the database will require updating with any changes to brands, such as modifications to the packaging or labelling, which will be submitted electronically to the FDA.

According to World Health Organisation estimates, counterfeit medicines comprise 6 per cent of the world market, higher in some areas, and developed countries are not immune to the problem. In the US, the number of cases of counterfeiting investigated by the FDA has gone up from a level of around five a year in the 1990s to more than 20 a year at present.