Regulators and Pharmaceutical Industry Leaders Are Invited to Join New International Pharmaceutical Supply Chain Consortium; First Meeting in Washington, D.C. on June 5
WASHINGTON, D.C. – March 4, 2009 – The board of advisors for Rx-360 issued an open invitation today to regulators, executives of pharmaceutical and biotechnology companies and their suppliers to join this new international not-for-profit organization. Rx-360 has been formed to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain.
The consortium will be comprised primarily of proprietary and generic drug product manufacturers and their suppliers of ingredients and components. Members will hold their first meeting on June 5, 2009 at the Ronald Reagan Building and International Trade Center in Washington, D.C.
“By building this consortium and bringing together leaders from the pharmaceutical and biotechnology industries, our suppliers and regulatory agencies, we can begin to address more directly and swiftly issues critical to a safe and successful supply chain,” said Martin VanTrieste, advisory committee member and Amgen vice president, Quality, Commercial Operations. “Rx-360’s mission is simple - improve the quality, authenticity and security of the global supply chain so that all patients benefit. Patient safety should never be a competitive advantage,” VanTrieste added.
The consortium is being chartered to develop operating standards, develop technologies, share data and create a supplier audit sharing function to improve the efficiency, oversight and accountability of the global pharmaceutical supply chain. The organization will be headquartered in the Washington, D.C. area utilizing existing infrastructure of similar organizations serving other industries.
The mission of the new organization is timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve.
Unethical players and noncompliant companies along the supply chain introduce counterfeited, adulterated and contaminated materials, often with tragic consequences. Recent highly publicized events include:
- Adulterated glycerin with diethylene glycol (antifreeze) used to manufacture cough syrup linked to 67 deaths in Panama and 103 deaths in Haiti (mostly children).
- Adulterated heparin with hypersulfated chondroitin sulfate linked to 81 deaths in the US and Europe.
- Adulterated milk with melamine linked to contaminated infant formula causing kidney stones and deaths of infants in China.
- Adulterated glycerin with diethylene glycol used to manufacture teething gel linked to over 40 infant deaths in Nigeria.
- The World Health Organization (WHO) estimates that 10% of all medicines around the world are counterfeit. In addition, it estimates that up to 30% of medicines sold in developing countries may be counterfeit, and some studies conclude that the percentage may be even higher. (www.wpro.who.int/media_centre/fact_sheets/fs_20050506.htm)
Regulators, pharmaceutical and biotechnology executives, supplier executives and members of professional organizations ultimately share a common mission, to serve patients. Legislators, regulators and professional organizations around the world are currently attempting to develop local solutions to this complex and global problem. The consortium aims to bring these independent efforts together to support a single global response.
“The time to act is now,” VanTrieste said. “Working together, we can create global quality and regulatory systems that address these threats to patient safety. I 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 patients.”
For more information on the upcoming summit or the consortium, or to attend the summit, please go to www.rx-360.org or send an email to [email protected]