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HDMA COMMENDS FDA FOR CONTINUED STRONG COMMITMENT
TO ENSURING PATIENT SAFETY, MEDICINE SUPPLY SECURITY
Nation’s Primary Healthcare Distributors Continue to Work with All Links in the Supply Chain, Government and Law Enforcement on Multi-Level Plan to Combat Counterfeiting, Ensure Safe, Efficient Delivery of Medicines
Arlington, VA – June 9, 2006 –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 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 distributor licensing standards;
- Uniform 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 healthcare distributors,
representing more than 90 percent of the distribution system, 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. For more than 125
years, HDMA and its members have been 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.
Related Links
HDMA JOINS THE FDA COUNTERFEIT ALERT
NETWORK
Arlington, VA (May
12, 2006) - As
part of ongoing efforts to fight the threat of counterfeit drugs
to the U.S. medicine supply, the Healthcare Distribution Management
Association (HDMA) joined the Food and Drug Administration’s
(FDA) Counterfeit Alert Network... Read
more
General Information
- Click here for
John Gray's testimony at the FDA Counterfeit Drug Task Force
Public Workshop/Vendor Display
- Click here for
HDMA President and CEO John Gray's Testimony before the Senate
Health, Education, Labor and Pensions Committee
- Click here for
Jon Borschow’s Testimony at the FDA Public Meeting on Counterfeiting
HDMA Guidelines for Distribution System
Security
Federal Activities
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