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| Thank you FDA for hosting the Counterfeit Drug TF workshop Feb 8-9 2006. This was an excellent means to educate all interested parties. We are concerned, as mentioned in the open mike comments, that FDA driven by the larger vendors, is bent upon an RFID solution to all the problems of e-pedigree and track and trace technology to the EXCLUSION of other technologies. RFID technology has it origins in WWII more than 60 years ago. American innovation has moved the bar forward. Solutions are available that can deal with tracking and tracing at the individual blister pack level, and as another speaker mentioned, at the individual pill level. A hybrid solution is appropriate if we are to get a firm grasp of this problem within the next few years. If FDA continues to wait upon RFID development, the timeframe for which a solution is implemented will continue to be extended, and no solution will be forthcoming within the working lifetime of those FDA decision makers today. We strongly urge FDA to set standards as very clearly requested by everyone involved at the workshop. We further strongly urge FDA, NOT to elect one technology for a solution, but leave the election of the technology used to members of the supply chain as long as it meets the standards set. The driving concern appears to be the need to get information and identity of each pharmaceutical unit into an electronic format to establish e-pedigree and assure cost effective electronic tracking and tracing. This can be accomplished in a number of ways and at a much lower cost than methods using chip or RFID technology. On the issue of privacy, the technology selected must be free from the danger of hacking. No chip technology to date can meet that standard. Further, the system and data base must meet an equal level of security. This strongly suggests that all persons involved in the administration and use of this data base use a biometric logon method at a minimum to authenticate the user and provide greater assurance that information is being appropriately handled and that should a loss occur the proper responsible person can be quickly identified. In keeping with our effort to educate decision makers to new technological advances we request you permit us an opportunity to show our new technology and it use in a practical demonstration at the earliest possible time. Thank you for this opportunity to comment.
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