Last week, we brought you part one of our interview with Martin VanTrieste, vice president of quality assurance at Amgen, a biotechnology company, and the co-founder of Rx-360, a global consortium formed to address weaknesses in the pharmaceutical supply chain. Now we bring you the conclusion of our interview.
PSM: It might surprise some that while a medication is manufactured in the U.S., its ingredients may come from overseas where there is less oversight and fewer regulations. Is there anything consumers can do to protect themselves from compromised ingredients?
Martin VanTrieste: Consumers must demand that everyone who influences the workings of the supply chain implement the necessary safeguards to protect them from compromised ingredients. This includes legislators, regulators and pharmaceutical companies.
PSM: You outline three-year objectives on your Web site, including the creation of an information infrastructure to share data. What kind of data would be shared between manufacturers and suppliers?
MVT: The consortium is working on a system that will not only make supplier audits more thorough, but that will allow firms to share audit findings and corrective actions. The idea is to reduce the number of audits at a particular supplier but increase the effectiveness of the audits performed. These shared audits will provide the pharmaceutical manufacturer more information than they obtain today and allow them to make better decisions on a supplier’s acceptability as it pertains to each individual company’s policies, practices and product requirements.
To learn more about Rx-360 or become a member of the consortium, visit their web site, Rx-360.org.