Volume 3   Issue  36                        November   2004

HDMA Applauds FDA for Continued Commitment to Ensuring Patient Safety, Healthcare System Integrity

PR Newswire November 16, 2004

"We commend the FDA for proactively communicating expectations to companies with pilot programs utilizing EPC/RFID," said HDMA President and CEO John Gray. "We'll continue to work with the FDA, state regulatory authorities and all stakeholders in the prescription drug supply chain, to maintain our focus on the safe, secure and efficient delivery of healthcare products. Distributors have an essential role in the healthcare industry delivery system and it is one that we take very seriously.

"HDMA believes EPC/RFID, combined with other safeguards such as authentication technologies, tough anti-counterfeiting laws, enhanced wholesale distributor licensing standards, and the adoption of best practices by all members of the supply chain, will dramatically improve public safety. Just in the past two weeks, the HDMA Healthcare Foundation released a report, 'Adopting EPC in Healthcare: Costs and Benefits,' which concluded that annual benefits of between $200 and $400 million can be achieved in reducing the many incidents of prescription drug counterfeiting. The most important goal is clear -- enhanced patient safety."

HDMA has worked steadily with the FDA and industry partners over the past three years to explore case studies and best business practices for efficient, timely and economical uses of EPC/RFID technology in continued efforts to enhance the safety and integrity of the nation's pharmaceutical supply.

"We'll need some time to review the FDA guidelines, but it appears at the outset they are a step in the right direction that will provide modern solutions that are patient safety-focused and cost-effective. Our objectives are to ensure that EPC/RFID is rapidly and effectively implemented throughout the pharmaceutical supply chain. HDMA stands ready to work with all our trading partners on this critical industry initiative to enhance the integrity of the healthcare marketplace," said Gray.

"This FDA initiative is an essential 'next step' that will accelerate enhancements in the supply chain -- and it is light-years beyond a proposed paper pedigree system that has been a 1970s solution to a 21st Century problem. Consumers deserve the best, 'state-of-the-industry' healthcare delivery system in the world.

"In essence, these guidelines will assist the industry in moving forward on improvements that succeed because they are efficient, economical and clearly benefit consumers. To skeptics of EPC/RFID," Gray continued, "I would emphasize that today there is industry-wide commitment and support for moving forward to create the most efficient and beneficial healthcare delivery system. This will increase security, reduce costs and improve product availability."

HDMA has been an association leader in healthcare industry activities to enhance supply chain integrity and patient security through the use of EPC/RFID, including:

• In August 2003 HDMA formed the Product Safety Task Force (PSTF), a cross-industry group charged with examining the development of anti- counterfeit technologies, particularly the business requirements for the use of these technologies. The PSTF's report, issued in July, broke down the migration path to full realization of EPC/RFID benefits by phases, and outlined the requirements for each phase.
• In November 2003, the HDMA Board of Directors approved a position statement calling for EPC/RFID adoption in the pharmaceutical supply chain, demonstrating the dedication of HDMA members to protect and to secure the nation's healthcare products. To support its position, the HDMA Board called for the establishment of a consistent, industry-wide EPC/RFID initiative to assist in the adoption, implementation, and utilization of the technology at all levels in the supply chain.
• In early 2004, HDMA finalized and circulated to states proposed state model legislation that is intended to reduce the threat of counterfeit, adulterated, or misbranded drugs from entering the marketplace. The model bill includes a mandate for use of electronic product identification of prescription drug products.
• In January 2004, HDMA signed a Memorandum of Understanding (MOU) with EPCglobal designed to help both parties identify common issues associated with EPC and to promote education and greater awareness of this technology. HDMA currently participates on several committees within the EPCglobal Healthcare & Life Sciences Business Action Group, which is charged with creating data requirements, data protocols, data access standards, and technical architecture standards for EPC/RFID.
• In January 2004, HDMA joined Project Jumpstart, an industry-wide proof of concept pilot project assessing the business value of emerging EPC/RFID technology, standards and processes to develop an industry operating model for a safe and secure supply chain. In September 2004, the group completed the first phase of the pilot project. The project demonstrated the ability of the technology to help participants create and maintain transaction histories for each product, manage returns and recalls, improve consumer safety through track and trace authentication, improve order accuracy, and increase productivity.
• In early November 2004, the HDMA Healthcare Foundation released a groundbreaking, industry research report, "Adopting EPC in Healthcare: Costs and Benefits." For a copy of the report, contact Susanna Robinson at 703/885-0214.

About HDMA

For more than 125 years, HDMA has worked with members to secure a safe, efficient and reliable healthcare distribution system that is able to provide life-saving health products and services. HDMA members are responsible for ensuring that billions of units of medication are safely delivered to tens of thousands of retail pharmacies, hospitals, nursing homes, clinics and other provider sites in all 50 states in the most efficient manner possible. HDMA members are a vital link in the healthcare system, providing highest-quality solutions that remove costs and empower providers to deliver care more effectively. Through our advocacy activities, HDMA operates at the forefront of healthcare, and ensures that members' perspectives and businesses are understood and addressed in legislative and regulatory arenas. For more information on HDMA, please visit their website.

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