Can Pharma Move in Lockstep?
Adopting RFID all at once could lower the cost of deployment, deliver business benefits and offset a government mandate to track drugs.
By Mark Roberti
On Sept. 27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. The law received very little attention in the media, but it contains a provision that charges the U.S. Food and Drug Administration (FDA) with "developing and using improved adverse-event data-collection systems, including information technology systems." In other words, the U.S. Congress wants the FDA to figure out how to capture information about counterfeit drugs entering the legitimate supply chain.
Randall W. Lutter, the FDA's deputy commissioner for policy, told a gathering at the U.S. Chamber of Commerce in Washington on Oct. 10 that the FDA indicated that it might call for some kind of pedigree system. "We're just starting to look at how we will implement the law," he said.
One of the biggest issues facing the pharmaceutical industry is the cost of implementing a pedigree system. A system that uses two-dimensional bar codes with unique serial numbers requires a great deal of labor. A person is needed to pick up each individual bottle, orient the bar code to the scanner and scan the bar code. Distributors who handle billions of unique items a year have indicated that using 2-D bar codes is not a viable option in their operations.
On Sept. 27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. The law received very little attention in the media, but it contains a provision that charges the U.S. Food and Drug Administration (FDA) with "developing and using improved adverse-event data-collection systems, including information technology systems." In other words, the U.S. Congress wants the FDA to figure out how to capture information about counterfeit drugs entering the legitimate supply chain.
Randall W. Lutter, the FDA's deputy commissioner for policy, told a gathering at the U.S. Chamber of Commerce in Washington on Oct. 10 that the FDA indicated that it might call for some kind of pedigree system. "We're just starting to look at how we will implement the law," he said.
One of the biggest issues facing the pharmaceutical industry is the cost of implementing a pedigree system. A system that uses two-dimensional bar codes with unique serial numbers requires a great deal of labor. A person is needed to pick up each individual bottle, orient the bar code to the scanner and scan the bar code. Distributors who handle billions of unique items a year have indicated that using 2-D bar codes is not a viable option in their operations.
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