We have written about the Rx-360 (www.rx-360.org) group numerous times in the past; it’s a volunteer organization that started up within the pharma industry in 2009, in the aftermath of the heparin scandal. The originating idea was to get industry to collaborate on common problems in manufacturing quality, given the fact that the market for pharmaceuticals is now more globally oriented than ever, and given the fact that most manufacturers depend on a network of suppliers of ingredients or APIs that span the globe. (The heparin scandal, you’ll recall, originated with raw material derived from pig intestines from farms in China; along the way, it was adulterated, nearly definitely intentionally, in a way that was essentially invisible to conventional analytical techniques. Ultimately, finished heparin was administered to numerous patients in the US and Europe, resulting in deaths that could be attributed directly to the adulteration.)
The Big Idea at the start of Rx-360 was to develop a system where different manufacturers or brand owners could share redacted versions of their audit and inspection data, so that each organization was not replicating what others had already done. If operated openly and responsibly, the system could represent significant savings in time and money for all manufacturers and suppliers who participate. That process has matured, and, following a pilot program that concluded this fall, RX-360 is now making its initial reports available to members.
Meanwhile, according to Brian Johnson, an Rx-360 director (and senior director of supply chain security at Pfizer), the group is now moving forward on a next stage: a newly formed Supply Chain Security Workgroup, which will focus on securing the transportation and storage of ingredients and finished goods, thereby filling out more of the end-to-end scope Rx-360. The workgroup, co-chaired by Johnson, will have four project teams: security assessments/audits for logistics providers and carriers; market monitoring/surveillance; security management systems; and risk assessment and processes to counter cargo theft. If it follows the pattern of the initial manufacturing quality audits, it could generate a need for a shared-audit process, an auditor qualification process, and uniform standards of audit elements. Development of tools for evaluations of physical locations (warehouses) is in progress. All this is a tall order.
This is occurring in an environment where FDA has signaled that, going forward, it is planning to increase its collaboration with the pharmaceutical regulatory agencies of other nations, because it will never have the resources necessary to adequately inspect and validate all sources of pharmaceutical products coming to US shores. That might be a necessary coming to grips with the current situation (where it would take roughly the next nine years just to inspect all currently known suppliers abroad, let alone engage in a thorough review), but it leaves some vague uneasiness about the reliability and level of performance of regulatory agencies worldwide on the table. Industry-sponsored efforts to the same goals can only help the situation.
Johnson says that today, with 23 manufacturers and 26 suppliers Rx-360 members (as well as a number of trade associations and auditing members), there is substantial industry participation—“but there needs to be more members from among smaller manufacturers, and broader international participation.” The door is now open for logistics service providers and carriers to be members, as part of the nascent supply chain security effort. It is to their credit that Doe & Ingalls, Envirotainer, LifeConEx, SICPA and TempTime—five companies vested in the movement of pharmaceuticals and APIs around the world—are already on board. More should join.