The buzz around Rx-360, an international pharmaceutical supply chain consortium headed by seven advisory panel members including Martin Van Trieste of Amgen, has been brewing for months. More than 125 people attended the consortium’s launch meeting in Washington, DC, last Friday, June 5—quite a few more than Van Trieste and his team originally expected. Clearly, the turnout demonstrated industry’s interest in working together to help improve supply chain security. Also demonstrating a yearning for cohesion were the results of the meeting’s live polling questions. Using devices to vote from their seats, 100% of meeting participants agreed that Rx-360 was needed. Most also said they would join or are considering joining the consortium.
When asked about which of Rx-360’s objectives they support, 20% said adopting industry standards; 13% said monitoring; 6% said technologies; and 61% said shared audits.
Regarding the last stat, when asked how comfortable they feel about sharing audits, 16% said shared audits were not an option; 33% said shared audits would require significant rework; 33% said shared audits could be adapted fairly easily; and 18% said they were good to go right now with shared audits (this latter group is most likely made up of smaller pharma and biopharma companies who have a difficult time getting large suppliers to let them conduct audits).
Rx-360 is proposing three types of shared audits for suppliers, which are described in more detail on the consortium’s website. The “sponsored” model involves a member company paying for Rx-360 auditors to conduct an audit of a supplier. The “Rx-360” model would involve a joint decision among a certain number of consortium members to audit a supplier. The “subscription” model would allow consortium members to submit and pull already conducted audits from a member database (those audits would have been done by the submitting company or a third-party).
After breakout sessions in which groups of about 6 to 10 individuals discussed the three proposed audit models, Rx-360 took additional polls: 67% said they think the sponsored model is viable; 90% said the Rx-360 model is viable; and 81% said the subscription model is viable.
While those numbers seem quite supportive of Rx-360’s efforts regarding shared audits, much work needs to be done before any model can be adopted. For example, 66% said they would not trust anonymous Rx-360 member company audit reports.
Very detailed standards would have to be established for audits conducted by Rx-360 or third parties, for the auditors themselves (qualifications, years on the job, etc.), and for audit reports in order for member companies to use and trust audit results. These audits would also have to be relevant to different types and sizes of pharmaceutical and biopharmaceutical companies in order to be useful. Some people at the meeting suggested the shared audits serve as a background guide for a company to obtain general information about a supplier and then decide whether or not a particular supplier needs additional auditing in certain areas.
In addition, members would need some type of FDA endorsement of Rx-360 based audits (Van Trieste has said that FDA is in support of their work thus far). Accreditation may be the way to go on that front—a route IPEA’s third-party audit program (established by the International Pharmaceutical Excipients Council) is already seeking.
And of course there are the suppliers themselves to consider when talking about shared audits. Given that they can no longer handle the amount of client audit requests, not to mention regulator audits, suppliers would benefit from a shared program. By letting a consortium such as Rx-360 conduct one very thorough audit that 5, 10, or even 100 clients can share, a supplier can save a lot of time and hassle. But would they receive some sort of monetary benefit for doing so? Would they be able to say, “We don’t want Company X to get a copy of this audit report” or “We don’t feel this audit report is justified?”
Clearly, the idea of shared audits is a good one but it also comes with many challenges and questions to be worked out. I hope Rx-360 can pull it off. Let us know your thoughts about shared audits.