In efforts to accelerate radio-frequency identification (RFID), the FDA was expected to release new, more vigorous guidelines for pharmaceutical adoption of RFID. Two years ago the FDA's Counterfeit Drug Task Force issued a report urging the adoption of RFID at the unit of sale level by 2007. The FDA also plans to conduct internal testing this summer to guarantee that biologics will remain stable in the presence of radio-frequency technology.
Yet, the pharmaceutical industry is barely using the technology. Only 2 drug companies are employing RFID, and each with a single product line, according to Paul Chang, associate partner of IBM Business Consulting Services. Scott Gottlieb, MD, FDA deputy commissioner for medical and scientific affairs, said during a recent drug counterfeiting conference, that a number of factors contribute to the existing impasse, including cost and logistic difficulties in setting up and managing the system.
Despite these factors, RFID implementation remains a top priority for the agency and is viewed as one of the only solutions to a growing drug counterfeiting problem. According to the World Health Organization, global drug counterfeiting is a $32-billion-a-year business.