Nonprofit Rx-360 has launched, following an event in Washington last week. The anticounterfeiting consortium's mission is to "create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain."
This is an organization that commands your attention. Its promotional materials include a stunning photo from the New York Times taken during the heparin contamination hearings. Its website features a "very graphic" UK commercial on the dangers of counterfeit drugs. No concerns about political correctness here. Its home page includes an interactive graphic of global counterfeiting events.
The consortium cites four functions: standard setting, technology development, data sharing, and shared supplier audits. It won't replace regulator audits, but officials from both the FDA and the European Medicines Agency are on board with the concept, the consortium says.
And it demonstrates a sense of urgency: spokesperson Charae Gibbs says that Rx-360 has decided not to use the International Conference on Harmonization process, "to implement solutions as swiftly as possible."
- visit the Rx-360 website
- watch the video