FDA Confident About Deadline for Implementing Electronic Pedigrees

The FDA believes it is well on its way to implementing an electronic pedigree system for drug products by its 2007 goal, according to a progress report on the agency's counterfeit drug initiative.

"We are pleased with the progress stakeholders, standard-setting bodies, and software and hardware companies have made thus far toward implementing an electronic pedigree for drug products," the FDA stated in the progress report. "We recognize that there have been, and continue to be, challenges along the way. However, we are optimistic that this progress will continue in an expeditious manner toward meeting our 2007 goal."

The use of electronic pedigrees has been a touchy subject in the drug industry, as most drugmakers have been pushing the FDA to implement a paper-based pedigree system before moving forward with an electronic system.

The FDA was poised to establish a paper-based system when it released a final rule on paper pedigrees in 1999, but the agency later decided to delay implementation of the rule to examine the possibility of developing an electronic system. Most recently, the FDA issued a stay last February delaying implementation of the paper pedigree rule until Jan. 1, 2007.

Shortly before issuing the most recent stay, the FDA announced a broad anticounterfeiting initiative, which, among other goals, established a Dec. 31, 2006, target date to implement electronic pedigrees for pharmaceutical products.

To view the progress report, "Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update," go to ()a href="http://www.fda.gov/oc/initiatives/counterfeit/update2005.html" target="_blank">http://www.fda.gov/oc/initiatives/counterfeit/update2005.html