HDMA Commends FDA for Continued Strong Commitment to Ensuring Patient Safety, Medicine Supply Security

ARLINGTON, Va., June 9 /PRNewswire/ -- The Healthcare Distribution Management Association (HDMA) supports the U.S. Food and Drug Administration's (FDA) decision to lift the stay on the Prescription Drug Marketing Act (PDMA) Final Rule. By implementing the Final Rule on December 1, 2006, the FDA is taking a step forward to further ensure patient safety, prescription drug integrity, and supply chain security.

HDMA has taken a strong stand to combat criminal counterfeiting, and in February called for the implementation of the pedigree provisions of the PDMA as an important interim measure to further improve supply chain security and patient safety. The pedigree provisions, however, are just one part of a comprehensive anti-counterfeiting strategy that must involve manufacturers, distributors and pharmacies. To that end, HDMA and the nation's primary healthcare distributors strongly support:

  *  Stricter, more uniform distributor licensing standards and pedigree
     requirements to ensure consistency across the 50 states;
  *  Tougher regulation, stronger law enforcement and harsher criminal
     penalties for the crime of counterfeiting medicine;
  *  The adoption of current and emerging track and trace technologies, such
     as RFID;
  *  The development of new research and best business practices in the
     supply chain.

"We have zero tolerance for criminals who counterfeit patient medicines, and we commend the FDA for moving forward with implementation of the PDMA Final Rule," said HDMA President and CEO John Gray. "This is an important step in an ongoing, multi-layered battle plan to further secure the supply chain and protect patient safety. We will continue to work with the FDA, state regulatory authorities and all links in the prescription medicine supply chain to maintain our focus on the safe, secure and efficient delivery of healthcare products.

"We commend the FDA for proactively holding workshops to gather critical information from across the healthcare industry to make this important decision," continued Gray. "Additionally we support FDA's focus on prioritizing pedigree enforcement efforts and its recommendation for continued industry leadership on technology advancements."

The nation's primary, full-service distributors deliver nine million prescription drugs and healthcare products daily to more than 142,000 pharmacies, hospitals, nursing homes, clinics and physician offices, for patients across the U.S. These HDMA member distributors are committed to a strong chain of custody for medicines and they have an essential role at the center of the healthcare supply chain.

HDMA has worked steadily with the FDA and supply chain partners for years to initiate and explore case studies to enhance the safety and integrity of the nation's pharmaceutical supply. HDMA and its members have initiated industry working groups, new research and guidelines for operational improvements. Additionally, HDMA and its member companies work daily with all links in the supply chain, federal and state regulatory authorities, law enforcement, the National Boards of Pharmacy, and technology companies to advance continuous improvements in policies and business processes.

"In my third year as President & CEO of HDMA, I intend to continue a full- court press on our work to facilitate cooperation and progress across the supply chain," Gray continued, "and I believe now, more than ever before, there is industry-wide commitment and support for working together."

About HDMA

The Healthcare Distribution Management Association (HDMA) and its members are committed to patient safety by delivering life-saving health products and services through a secure and efficient healthcare distribution system. These primary, full-service healthcare distributors are responsible for ensuring that billions of units of medication are safely delivered -- to tens of thousands of retail pharmacies, nursing homes, clinics and providers -- in all 50 states. HDMA and its members are the vital link in the healthcare system that is responsible for medicine safety, quality, integrity and availability in the marketplace. Through leadership on public policy and industry best practices, HDMA and its members focus on providing value, removing costs and developing innovative solutions to deliver care safely and effectively. For more information, please visit http://www.healthcaredistribution.org/.