PA’s Authentication at the Point of Dispensing™ process enables manufacturers to adopt FDA Counterfeit Drug Task Force’s recommendations for securing drug supply chain
PA Consulting Group, a leading management, systems and technology consulting firm, announced its full support for the Food and Drug Administration’s (FDA) recommendations for securing the pharmaceuticals supply chain. The recommendations were announced today at a briefing for reporters hosted by the FDA in Washington, DC.
The FDA counterfeit drug task force has released its findings after wide consultation and careful deliberation since July 2003. PA is proud to have been involved in this process from its inception, which included an outline of our Authentication at the Point of Dispensing™ process.
According to the report that was released today, the counterfeit drug task force recognizes that securing the supply chain for pharmaceuticals requires sound business practices and technologies such as radio-frequency identification technology (RFID) and other mass serialization methods. Many pharmaceutical manufacturers have been watching the development of RFID. All see opportunities for RFID yet the overall business benefits are not yet certain. The FDA comments in this report raise the profile of RFID and the importance of understanding how it will impact each organization.
In response to today’s report, PA’s Andrew Gill and Rob Whewell, who have jointly led the firm’s consultations with the task force, commented:
“RFID study and implementation up to this point have been piecemeal and loosely co-ordinated, yet the implications are complex and will impact all areas of a company’s business.
“A few companies have started to move forward with RFID positively, but they are struggling to identify how to implement anything across the range of stakeholders in the industry, and are having difficulty establishing a robust business case,” added PA’s Gill and Whewell.
PA is currently planning a cross-industry program, Authentication at the Point of Dispensing™, involving four of the top ten global pharmaceutical manufacturers and a range of retail pharmacy outlets. Participation in the program enables these companies to develop a position for RFID within their organizations and provide a robust business case, including brand protection, for moving forward. PA is currently recruiting additional manufacturers and pharmacies to participate in the program in 2004.
PA Consulting Group fully supports the FDA task force findings and our experience in technology strategy development will enable pharmaceutical companies to implement the FDA “Business steps for industry,” including:
- developing a policy, strategy and business case for RFID;
- creating an internal team focused on RFID and mass serialization technologies;
- performing internal studies; and
- conducting external pilot studies with supply chain stakeholders (eg Authentication at the Point of Dispensing™).
For more information about PA’s involvement with the FDA counterfeit drug task force, please refer to the docket filed with the FDA on November 21, 2003, available through the FDA’s Web site at:
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/112193/03N-0361-emc-000037-01.doc
