 | Tuesday, December 12, 2006
Issue 500 | | Will Smith, Editor |  |
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Editor's Note: Today's top story is the recent injunction that blocks the FDA's pedigree requirement for pharmaceuticals, a development that could stall progress in the adoption of RFID for e-pedigrees.
Transactions giant NCR today announced a solution that enables manufacturers to quickly and readily meet retailer RFID mandates. The company claims that NCR RFID Retail Compliance is "out-of-the-box", allowing companies to get up and running in a matter of hours. The package includes NCR application software, an RFID printer, a bar-code scanner, and a startup supply of Gen2 RFID tags.
Lastly, RFID training company RFID4U today announced three new training courses for 2007: CompTIA RFID+ Weekend boot camp, Asset Tracking using RFID, and RFID in Healthcare. Read the announcement for details. |
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| | - IDTechEx RFID Smart Labels USA 2007, Feb 20-23, Boston, USA (site) | | - RFID World Conference 2007, March 26-28, Dallas (site) | | - 5th Annual RFID Journal LIVE!, Apr 30 - May 2, 2007, Orlando (site) | | - Asset Tracking & Management in Defence, 31 Jan & 1 Feb, UK (site) | | | | - Locate it now. How? Ekahau. That's how! (site) | | | Training & Certification | | - University of Kansas RFID Training Programs (site) | | - Be Prepared. Heathkit's RFID+ Test Prep (site) | | | Products & Services | | - Peel - Stick - Ship(TM): SimplyRFID Pre-Programmed Tags (site) | | | Employment | | - RFID Recruiters - 100% Focused on RFID Recruiting (site) | | | RFID Readers | | - Ensyc Technologies: $395 UHF Desktop Reader (site) | | - MTI Wireless Edge: high-quality low-cost panel antennas (site) | | | RFID Tags & Labels | | - Lowry Smart Trac Labels: Depend on 100% Good Labels (site) | | | Research & White Papers | | - 2006 RFID Marketing Strategies Report from RFID Update (site) | |
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Injunction May Slow Momentum for RFID E-Pedigrees
US government efforts to tighten security in the pharmaceutical supply chain hit a roadblock last week when a federal court judge issued an injunction that lifts pedigree requirements for drug shipments. While RFID had not been a requirement for the pedigrees, industry observers agreed that pedigree enforcement generally was a positive step toward the ultimate adoption of RFID-based e-pedigrees. Thus, with the FDA pedigree requirement now postponed, momentum behind RFID e-pedigree adoption may be slowed.
The requirement was originally established in 1987 as part of the Prescription Drug Marketing Act (PDMA), but it was stayed repeatedly for years in hopes that practical technology solutions could be developed. The FDA, drug manufacturers, wholesalers, distributors, and various industry associations have all expressed confidence in RFID to efficiently meet pedigree requirements and have promoted use of the technology. RFID's emergence and success in pilots led the FDA to remove its stay this summer and start requiring paper pedigrees effective January 1, 2007, with the idea that paper pedigree adoption would accelerate the realization of e-pedigree adoption. (See What the FDA Announcement Means for RFID and RFID Industry Implications of the FDA Update for more.)
However, ten pharmaceutical wholesalers filed suit against the FDA's Department of Health and Human Services in federal court to block the pedigree requirement, claiming it would cause them irreparable harm. Judge Joanna Seybert of the Eastern District Court of New York agreed, and issued the injunction last Friday. The injunction effectively preserves the status quo; that is: no new pedigree requirements for wholesalers.
Jayne Juvan, Esq., an attorney specializing in health and pharmaceutical law who is following the case, told RFID Update the injunction is likely to stay in effect until the suit is ultimately resolved, which could take years. Juvan and her law firm, Benesch Friedlander Coplan & Aronoff LLP, are not involved in the proceedings. Juvan said the injunction could be lifted through a successful appeal, but that is not likely based on legal precedent and the standard of proof.
"I don't think we'll see final resolution on this any time soon -- it could be years," said Juvan, who maintains a blog that provides news and analysis about the suit. "It's very, very early in the litigation process."
Ultimately, the courts tend to favor the government in cases such as this that allege Equal Protection Clause and Due Process Clause violations when the rational basis test applies, according to Juvan, making it unusual and noteworthy that the plaintiffs won the injunction in the first place. At this phase, however, the court simply assessed whether the plaintiffs were more likely than not to succeed on the merits of their claims. Given the rigorous standard, and unless there are regulatory changes in the interim, she said, it is likely that the FDA pedigree requirements will eventually take effect.
"The plaintiffs have a long way to go in the course of litigation, but the grant of the preliminary injunction was a major victory in their favor," said Juvan. "Showing that a statute is not rationally related to a legitimate government interest is difficult, as the burden is placed on the challenger of the law and the government often wins these cases. Nevertheless, good lawyering and maneuvering could still swing this in the plaintiffs' favor."
It is important to note that the plaintiffs did not file suit to block the requirements because they oppose pedigrees. (Indeed, the lead plaintiff, Rx USA Wholesale, says it has a pedigree system in place and could comply with the requirements.) Their complaint is that the requirement as written places an unfair burden on the estimated 10,000 small and midsize drug wholesalers in the US. The plaintiffs argue that the "Big 3" drug distributors -- AmerisourceBergen, Cardinal Health, and McKesson -- are exempted from the requirement and could therefore make it impossible for smaller, secondary distributors to comply by withholding information. The suit also names 16 pharmaceutical manufacturers and the Healthcare Distribution Management Association (HDMA), a trade association for healthcare distributors. HDMA did not respond to RFID Update's request for comment.
On the same day the injunction was granted, HDMA issued a press release praising the new FDA commissioner. The release quoted HDMA President and CEO John Gray as saying: "HDMA and its members -- the nation's primary, full-service healthcare distributors -- look forward to continued work with the FDA on the many important healthcare issues facing our industry. Our top priorities include the implementation of the Prescription Drug Marketing Act (PDMA) and the industry-wide utilization of current and emerging anti-counterfeiting technologies."
For their part, AmerisourceBergen, Cardinal Health, McKesson, and the HDMA are among the leaders in promoting RFID for pharmaceutical pedigrees. In November, AmerisourceBergen announced an RFID-based track-and-trace initiative, and Cardinal released results of its RFID trial (see Pharmaceutical Pilot Finds Promise, Problems).
For additional information, Rx USA Wholesale maintains a library of court filings, and Dr. Adam Fein also tracks the case on his pharmaceutical law blog.
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| Upcoming Events | IDTechEx RFID Smart Labels USA 2007, Feb 20-23, Boston, USA
RFID Smart Labels USA 2007 covers all RFID applications and technologies. Highlighting the business case, item-level tagging, RFID progress around the world and state-of-the-art technologies, RFID Smart Labels USA will be 2007's premier learning forum for RFID. Hear from 60+ industry-leaders including Coca-Cola, Unilever, Rolls-Royce, BGN, USPS, Michelin, McCarran Airport, IATA. www.smartlabelsUSA.com | RFID World Conference 2007, March 26-28, Dallas
Attend RFID World, the largest event focused on RFID and Advanced End-to-End Track & Trace Solutions. RFID World is where the industry gathers to meet face-to-face, making it the most effective place to generate awareness, leads and sales. Learn more and register at www.rfid-world.com | 5th Annual RFID Journal LIVE!, Apr 30 - May 2, 2007, Orlando
Get everything you need to put RFID to work today at the world's largest RFID conference & exhibition. Access the most case studies, the most how-to sessions and the most lessons learned. The 86,000 sq.-ft. exhibit hall will feature the leading technology providers. Plus, Walt Disney World Resort packages available. Information: http://www.rfidjournal.com/live2007 | Asset Tracking & Management in Defence, 31 Jan & 1 Feb, UK
Tracking materials from warehouse to warfighter improves the effectiveness of global logistics systems. This conference explores how participating nations are implementing RFID and how codification and data management facilitate global logistics operations. Learn to define mandated requirements and address problems at technical and management levels. For more information visit: www.smi-online.co.uk/rfid8.asp | | | 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. | | | Training & Certification | University of Kansas RFID Training Programs
Researchers at the RFID Alliance Lab at the University of Kansas are leading the RFID field with pioneering research. Now the University of Kansas is turning that research into revenue for businesses across the country through its RFID training programs focused on Item-Level Tracking, Cold Chain Tracking, and Asset Management. www.continuinged.ku.edu/programs/rfid | Be Prepared. Heathkit's RFID+ Test Prep
Heathkit's RFID+ Test Prep Program prepares individuals to successfully take CompTIA's RFID+ certification exam. Use Heathkit's Interactive Assessment Tool to highlight RFID technology areas that have already been mastered and pinpoint those concepts requiring additional study; don't waste time searching through RFID topics you already know. Be prepared... get Heathkit's RFID+ Test Prep. | | | Products & Services | Peel - Stick - Ship(TM): SimplyRFID Pre-Programmed Tags
Military-grade, Class 1 Generation 2 RFID Tags pre-programmed to DoD 252.211-7006 specifications shipped same day for less than $1 each. Find out why over 1,000 DoD (Department of Defense) suppliers choose SimplyRFID for their RFID needs. Visit us at www.SimplyRFID.com for no hassle RFID solutions. | | | 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 | | | RFID Readers | Ensyc Technologies: $395 UHF Desktop Reader
The RFID Block reader is powered by a simple USB connection, works with EPC Class1 Gen1 or Gen2 tags and makes it easy for your business to meet mandates or simply investigate the potential of RFID. Developers will also find the RFID Block a useful tool for application testing. Visit: www.ensyc.com | MTI Wireless Edge: high-quality low-cost panel antennas
* Covering all applicable frequency bands for Passive and Active RFID * Various mechanical configurations for Indoor and Outdoor applications * Single or Dual Polarities * Linear or circular polarities * High robustness and endurance * Field proven in harsh environments * Enhancing system performance * Solutions tailored to customer needs: www.mtiwe.com | | | RFID Tags & Labels | Lowry Smart Trac Labels: Depend on 100% Good Labels
Lowry provides a comprehensive range of UHF and HF labels. With innovation and investment in the RFID marketplace, Lowry offers more than label conversion. Lowry's RFID Lab assists with inlay selection and label materials to deliver optimum performance. Rely on Lowry's experience and quality commitment. 1.800.733.0210 x 312 or visit www.lowrycomputer.com | | | Research & White Papers | 2006 RFID Marketing Strategies Report from RFID Update
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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RFID Update is the RFID industry daily. Launched in early 2004 to provide timely analysis of RFID industry news, RFID Update publishes editorial briefings every weekday for the growing ranks of top level executives involved in the deployment of RFID. Each issue delivers the breaking news and analysis most pertinent to successful RFID implementations, allowing readers to understand global RFID developments as they happen.
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