HDMA Applauds FDA Final Counterfeit Report

RESTON, Va., Feb – The Healthcare Distribution Management Association (HDMA) strongly supports the U.S. Food and Drug Administration's Final Report on combating counterfeit drugs, particularly the agency's recommendations for technology-based solutions for the electronic tracking, tracing, and authenticating of pharmaceuticals; the adoption of secure best practices by all pharmaceutical supply chain stakeholders; the need for stronger anti-counterfeiting laws and enforcement at the state level; and the need for increased penalties for those that counterfeit drugs.

"The FDA should be commended for supporting tough new anti-counterfeiting solutions," says HDMA Executive Vice President and COO Nancy Hanagan. "We will continue to work in close collaboration with the FDA on the implementation of its recommendations at both the state and federal level."

To that end, HDMA will support the FDA by urging:

All 50 states to adopt uniform due diligence standards for the licensure and inspection of wholesale distributors. This is the only way to ensure the rigorous and consistent standards that will help prevent illegitimate operators from conducting business in any U.S. state. Pre-licensure inspections, criminal background checks, and more consistent ongoing enforcement by licensing authorities are absolutely essential anti-counterfeiting strategies.

The widespread adoption of RFID/EPC technology by pharmaceutical manufacturers, wholesale distributors, and pharmacy customers as the best solution for combating the public safety threat of counterfeit drugs. HDMA is solidly committed to this technology, and is in the process of developing business standards for RFID/EPC implementation.

The adoption of stringent security best practices and other tough compliance measures on the part of supply chain stakeholders that will further protect the U.S. pharmaceutical supply.

For years, HDMA and its members have been independently developing anti-counterfeit measures in an effort to protect and secure the U.S. pharmaceutical supply. Many of these measures are recommended for the entire pharmaceutical supply chain in the FDA's Final Report.

1. HDMA led efforts to call for stronger, more uniform state licensure and inspection requirements in order to guarantee consistency across all 50 states and to prevent suspect wholesale distributors from entering the marketplace. HDMA worked with NABP in that group's development of Model Rules for state licensure, and with the Florida Department of Health in its effort to strengthen licensure laws in 2002.

2. HDMA members in July 2003 pledged to notify the FDA and the product manufacturer within five working days of discovery of a suspicious product. The program goes beyond our nation's borders, and includes counterfeit drugs that could be brought into the United States from foreign countries.

3. HDMA formed and held the first meeting of the Product Safety Task Force (PSTF) in August 2003. The PSTF is a cross-industry group charged with the responsibility for examining and supporting the development of anti-counterfeit technologies. This task force has been developing the business requirements for the use of track and trace technology, with a goal to define them by April 2004.

4. HDMA approved in November 2003 a position statement calling for RFID/EPC adoption in the pharmaceutical supply chain at the case level by December 2005 and at the selling unit level by December 2007.

5. HDMA adopted in November 2003 a set of industry best practices for wholesaler members to implement entitled the HDMA Guidelines for Pharmaceutical Distribution System Integrity. The HDMAGuidelines call for extensive due diligence on the part of pharmaceutical wholesale distributors in order to greatly improve the safety and the security of the distribution pipeline.

6. HDMA enacted in January 2004 a membership bylaws change requiring active members to adopt best practices embodied in the HDMA Guidelines that include extensive regulatory, financial, security, and due diligence processes and procedures.

7. HDMA strongly supports the need for increased penalties for drug counterfeiting in order to deter criminal elements from entering the marketplace. HDMA will continue to support the FDA in recommending that these penalties be increased this year.

HDMA's mission is to secure safe and effective distribution of healthcare products, create and exchange industry knowledge affecting the future of distribution management, and influence standards and business processes that produce efficient healthcare commerce.

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