Martin VanTrieste

Welcome to the first edition of Rx-360 News.  My fellow advisory board members and I are very pleased to bring you the latest developments on the new Rx-360 organization as well as on supply chain news in industry.

As you may have heard my colleagues or I say at recent conferences, or perhaps you’ve read, Rx-360 is a not-for-profit, international supply chain organization developed by members of the biotech, pharmaceutical and generic drug industries, including their suppliers. 

Our mission is to create and monitor a global quality system that meets the expectations of industry and regulators, that assures patient safety by enhancing the quality and authenticity of products moving through the supply chain.

I’ve heard people ask: Why create this organization and why now? As you’re aware, millions of people around the world are treated every day with the vital medicines discovered and developed by the pharmaceutical and biotech industries. Management of the drug supply chain has become one of the top public health concerns with respect to consumer safety.

Globalization of distribution for both drug components and finished products has introduced many complications that challenge the security of the supply chain. These complications can provide, and have provided opportunities (take the adulterated heparin and melamine contaminations as an example) for unethical players and noncompliant companies to introduce counterfeited, adulterated and contaminated materials, often with tragic consequences. 

We have a responsibility to patients to take measures to prevent such tragedies from happening again – and that’s what we plan to do. 

Our vision is big and bold - we need a global quality system that meets the expectations of industry and regulators.  There have been many debates on whether this vision and mission are too big or even possible.  Due to the size, complexity and global nature of the issue, though, we believe a big and bold initiative is not only possible, it’s critical to effectively and efficiently address the issue.

Rx-360 has made great progress since our initial conversations at the PDA / FDA Supply Chain Conferences in Washington, DC and San Diego and our first formal teleconference over the winter break on December 27, 2008.

Since that first teleconference, Rx-360 has obtained positive responses and encouragement from many interested parties, including pharmaceutical, biotech and generic manufacturers, their suppliers along with various regulators.  As such we have received commitments from over 50 organizations to join Rx-360, providing the critical mass to ensure success.

There are many noble initiatives around the world, attempting to solve this complex global problem. Rx-360 will attempt to bring these various initiatives together, leveraging the strength of each initiative rather than trying to compete with these initiatives.  If we fail to leverage the strengths of each initiative through coordination and collaboration, the end result will be a system and supply chain with a higher risk profile that could lead to more patient deaths and a lack of consumer confidence in their medications.

I strongly urge everyone to work collaboratively to solve this complex global problem, putting aside individual interest, so that we can put global systems, procedures and practices in place that will effectively and efficiently protect and serve patients. 

Rx-360 has made great progress in this arena as well.  For example, the PDA (Parenteral Drug Association), IPEC (International Pharmaceutical Excipients Council), EFCG (European Fine Chemical Group), SOCMA (Synthetic Organic Chemical Manufacturers Association), NIPTE (The National Institute for Pharmaceutical Technology and Education), and BIO International have agreed to work collaboratively with Rx-360 such that the missions of all organizations are served.

To learn more about Rx-360 go to www.Rx-360.org.  Registration on the website is free.  To become a member of Rx-360, please send an e-mail to info@Rx-360.org.  My fellow advisory board members and I look forward to working with you to answer this call to action - to protect patients - and we look forward to the day when we can reflect on the outcomes of our work and see that our actions made a difference in the lives of those patients.