FDA Decides To Track Pharmaceuticals

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Main Category: Public Health
Also Included In: Litigation / Medical Malpractice;  Pharma Industry / Biotech Industry
Article Date: 10 Jun 2006 - 9:00 PDT


The FDA has decided to track pharmaceuticals from the factory, to wholesaler to pharmacy. In fact, there is an 18-year-old law that requires wholesalers to track drugs from the factory to the retail outlet - the pharmacy. The FDA will now enforce this law.

This move is aimed at stamping out the traffic of counterfeit drugs - drugs that look the same as the real thing, but either do not contain the essential active ingredient or have some contaminants. If a drug does not have the essential active ingredient it is completely useless.

The number of cases involving counterfeit drugs has been growing over the last few years. In 2000 the FDA had to investigate 2000 cases, in 2004 58 cases and in 2005 32 cases.

This new move makes it easier to stop the traffic of fake prescription drugs lower down the chain, rather than trying to catch people in back alleys at the end of the supply chain. It will make it more difficult for the criminal to slip his/her fake products into the supply chain.

Why hasn't the FDA been enforcing this law for the last 18 years? The main reason was that wholesalers said they would fold up if the law were enforced.

With Radio Frequency Identification (RFID), which is available today, it is much easier now to track drugs as they make their way up the chain from production, wholesale to retail.

Randy Lutter, FDA, Associate Commissioner for Policy and Planning, said there is an arms race between authorities and counterfeiters. The counterfeiters are forever trying to discover some new way of fooling investigators, public health authorities the FDA, and manufacturers He said his job is to make sure the authorities are always one step ahead of them.

Drug manufacturers and pharmacies don't have to have the new tracking technology in place, said the FDA. This would delay the implementation of the law even more. However, secondary wholesalers will have to have adopted the new technology by the beginning of December, 2006.

http://www.fda.gov/counterfeit Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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