 | Tuesday, April 29, 2008 Issue 829 | | Will Smith, Editor |  |
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 | Editor's Note: Today's top story is the bill introduced in the US House of Representatives that calls for the establishment of drug pedigree and identification standards, and directs federal officials to assess RFID's suitability for meeting them. The new legislation, however, appears to duplicate requirements set forth in the PDMA and the FDA Amendments Act of 2007.
Industrial supplies conglomerate Honeywell will acquire AIDC hardware and software manufacturer Metrologic for $720 million in cash. Raymond James analyst Chris Quilty believes the acquisition points to Honeywell's interest in strengthening its position across the AIDC marketplace, which of course includes RFID: "Honeywell is obviously serious about building a bar code empire. Probably safe to assume that they're not done, which means that Psion Teklogix, EMS Technologies, Datalogic, Intermec, or even Zebra could become targets down the road. Or, how about an early stage RFID company?" See the acquisition announcement for more details.
Lastly, RFID infrastructure provider Reva Systems today announced the integration of its flagship product the Tag Acquisition Processor, or TAP, with Oracle's E-Business Suite. The companies indicate that such integration will enable enterprises with E-Business Suite deployed to better harness RFID data coming from the enterprise edge. |
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| RFID Tags & Labels | | - Confidence in RFID - Confidex tags and tickets (site) |  | | RTLS & Active RFID |  |  Sponsored by Ekahau |  |
| | - Locate it now. How? Ekahau. That's how! (site) |  | | Products & Services | | - PCB Tracking & Visibility Solution from Omnitrol Networks (site) | | - Employees steal over $1 billion per week from employers (site) |  | | Upcoming Events | | - AWA PABS08 N. America Conference, Sept 11-12, Chicago, IL (site) | | - AWA PABS08 Asia Conference, Dec 4-5 - Hong Kong, China (site) | | - European Supply Chain & Logistics, 13-15 May, Germany (site) | | - SCAN & RFID CHINA 2008, June 19-21, Guangzhou, China (site) |  | | Employment | | - RFID Recruiters - 100% Focused on RFID Recruiting (site) |  | | Research & Whitepapers | | - RFID Marketing Strategies Report (site) |  |
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 Newest Drug Pedigree Proposal Highlights RFID
 By John Burnell
 Yet more legislation has been introduced to require individual identification and pedigrees for prescription drugs in the US, and RFID technology is again highlighted as a potential solution. Last week congressmen Rep. Jim Matheson (D-UT) and Rep. Steve Buyer (R-IN) introduced H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008, a bill that calls for the federal government to develop drug identification and tracking systems to prevent counterfeiting. It specifically requires drug pedigrees and directs the Secretary of Health and Human Services to submit a feasibility report for using RFID, bar code, and other technologies.
The Safeguarding America's Pharmaceuticals Act of 2008 is new legislation and should not be confused with the Food and Drug Administration Amendments Act of 2007, a federal action that required the Food and Drug Administration (FDA) to establish national standards for drug identification and pedigrees (see FDA, EC Considering RFID for Drug Pedigrees).
"The Buyer-Matheson bill gives teeth to the FDAAA provision which called upon FDA to develop standards for an identifier and for a track and trace system," Rep. Matheson's communications director Alyson Heyrend said in a statement to RFID Update. "Under FDAAA, the FDA was given 30 months to develop the identifier standard; no such deadline was given for the track and trace standard. Our bill directs FDA to announce the standard by the end of March 2010 (which would be the 30 month deadline given in FDAAA), and within 18 months of the standard's announcement, manufacturers of high-risk drugs (those at high risk for counterfeiting or diversion) must place identifiers (which meet the FDA standard) on their high-risk products."
The FDA has required drug pedigrees since 1988 when the Prescription Drug Marketing Act (PDMA) became law, but the PDMA's pedigree requirements have repeatedly been stayed because of implementation concerns (see Injunction May Slow Momentum for RFID E-Pedigrees).
Rep. Buyer acknowledged the PDMA in his press release announcing H.R. 5839, which suggests the emergence of online pharmacies has rendered PDMA-mandated protections inadequate.
The bill would give the FDA authority to seize and destroy drugs at US ports of entry, establish new distributor licensing standards, require unique serial numbers for all prescription drugs, require pedigrees starting with the wholesale distributor, and require track-and-trace systems. It would also provide funding for small pharmacies to help them implement necessary technology.
"Additionally, the FDA is in charge of determining which drugs are at high risk for counterfeiting or diversion. Manufacturers must be given a year's notice before one of their drugs is placed on the list," Heyrend said.
The National Association of Chain Drug Stores (NACDS), which represents retail pharmacies, responded to H.R. 5839 by asking Congress to focus on efforts that would prevent counterfeit pharmaceuticals from entering the supply chain, rather than tracking them. In a press release, the association said: "We urge Congress to carefully examine all proposals and not prematurely mandate technologies that are still under development. Efforts to enhance the security of the drug supply chain must be feasible, practical, reliable, and cost-effective."
A NACDS spokesperson told RFID Update the organization was still studying the proposed legislation and could not comment on how it differs from previously established federal pedigree and identification requirements.
As overlapping federal efforts slowly work their way through the legislative process, states are creating their own drug pedigree and identification laws (for a summary, see this useful visual by the Healthcare Distribution Management Association). The NACDS recently helped block implementation of pedigree requirements in California, where there were concerns about industry readiness and the ability to ensure an adequate drug supply if the new regulations took effect (see California Not Ready for Drug Pedigrees -- Is RFID?).
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| RFID Tags & Labels | Confidence in RFID - Confidex tags and tickets The challenges of various industries lead Confidex to develop a comprehensive offering of special tags and labels. Confidex tags are used in a variety of applications ranging from tracking items in the retail supply chain to automotive manufacturing and petrochemical installations. Confidex designs and manufactures contactless tickets for public transport. Visit www.confidex.fi |  | | RTLS & Active RFID | Locate it now. How? Ekahau. That's how! Ekahau RTLS (Real-Time Location System) automatically tracks assets and people via your existing Wi-Fi network. Control costs and improve asset management with Ekahau. For more information, visit us at www.ekahau.com. |  | | Products & Services | PCB Tracking & Visibility Solution from Omnitrol Networks Off-the-shelf solution provides automated real-time visibility and complete electronic pedigree for traceability on parts and WIP providing real-time dashboards, alerts and reports for shop-floor management. The pedigree information is automatically programmed into Texas Instruments' RFID tag for access to critical data without the need for connection to a back-end database. Learn more. | Employees steal over $1 billion per week from employers the American Management Association reports. 95% of businesses are victimized by employee theft. Managers are reluctant to ask questions, because trusted employees may feel offended, leaving business owners in a difficult situation. What can you do? Nox: Intelligent Perimeter Defense from Simply RFID provides advanced security and protection for business assets. |  | | Upcoming Events | AWA PABS08 N. America Conference, Sept 11-12, Chicago, IL AWA is organizing the Product Authentication & Brand Security Conference 2008 on September 11-12 in Chicago, IL. The event includes presentations and panel discussions with brand owners, legal authorities, associations, converters and suppliers; also networking sessions, a supplier forum, a social program and more. Find more on the program here. | AWA PABS08 Asia Conference, Dec 4-5 - Hong Kong, China AWA presents the Asian Product Authentication & Brand Security Conference 2008, to be held on 4 & 5 December in Hong Kong, China. PABS08 Asia focuses on the threats specific to the Asia Pacific region, various elements of IP Theft, and leading-edge solutions. Find more on the program here. | European Supply Chain & Logistics, 13-15 May, Germany Bringing together Europe's leading providers of supply chain management to evaluate best practices and to move the supply chain agenda into the boardroom. Also, featuring the AMR Research Strategy Session: What makes a supply chain world class in today's global market? More information here: www.supplychain.eu.com | SCAN & RFID CHINA 2008, June 19-21, Guangzhou, China As one of the earliest, most specialized and authoritative exhibitions in China, approved and supported directly from State Ministry, the 8th SCAN & RFID CHINA 2008 will present you the impressive up-dated development and market of RFID technology in rising China. To know more, please go to www.scan-china.com. |  | | Employment | RFID Recruiters - 100% Focused on RFID Recruiting Whether your company is looking for the best RFID talent or you have the best RFID talent and are looking for the best RFID employer, RFID Recruiters offers the most focused approach to your objective. To learn how the RFID industry and the RFID job market are evolving, visit www.rfidrecruiters.com |  | | Research & Whitepapers | RFID Marketing Strategies Report Thirty-nine pages of original research on RFID audience perceptions, including 30+ figures of tactics, content & messaging, and recommendations to guide marketing strategy. Also, Top-10 RFID company rankings based on 550+ survey respondents. View the executive summary free, with Top-3 sample rankings. Only $495 Individual License or $795 Corporate License. Available now |
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