The U.S. Food and Drug Administration (FDA) has recently announced some new measures that it will take in order to stem the tide of counterfeit prescription drugs coming into the United States.
Counterfeit medications (products that are sold with fake labels and packaging) are a major problem here in the U.S. Although we have stringent regulations and guidelines set out by government agencies and pharmaceutical companies, counterfeit drugs do manage to make it into circulation.
As technology improves in the world, so does the fake drug trade. Not only is this practice illegal, but it’s also extremely dangerous for the consumer. When it comes to drugs, you need to get exactly what you pay for — otherwise it could become a matter of life or death.
To address this issue, the FDA has decided to set up a new, more technologically advanced system to “track and trace” drugs within the country. Back in 1987, the Prescription Drug Marketing Act was passed. It required that companies distributing medications document the location and movement of their products — from production right up to the point that they are the customer’s hands. This documentation is termed to be a “pedigree.” However, due to the technology and costs involved, some of the provisions that related to the pedigree were put on hold — until now.
How exactly does the FDA expect the entire pharmaceutical industry to track each and every individual product sold? This can be fairly simple — with the right technology — although it will require some spending on the part of drug distributors. Track and trace technology is already in use by many other industries — just look at large courier companies, for example. If you send out a package, you can go on-line and find out exactly where it is at any given moment.
Similarly, a drug company can use radio-frequency identification to create an electronic pedigree for each package of medication it produces and ships. No muss, no fuss — and no paperwork to lose! Each individual drug package will have its own unique ID number and all its information readily available to government officials and manufacturers/shippers. This means that it will be even more difficult for counterfeit drug traffickers to sneak their questionable products into the system.
The FDA expects to start enforcing the regulations requiring pedigrees on drug packages in 2007. To make this system effective, it’s important that all drug manufacturers and distributors take part. To this end, there will be penalties and possibly criminal prosecution for companies that don’t comply with the FDA’s rules.