“Patient safety is at the core of FDA’s public health mission; and ensuring reliable patient access to safe and effective medicines requires maintaining a closed, secure U.S. drug supply chain for the distribution and delivery of finished drug products” said Scott Gottlieb on February 28, 2018 at FDA Public Meeting on Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA).
The Commissioner emphasized the fact that “every link in that chain must be secure, from the moment finished drug products leave manufacturing facilities to final delivery to pharmacies or providers’ offices where medicines are ultimately dispensed to patients.” Reaching that milestone, on time, is a high priority for FDA.
FDA already accomplished a tremendous amount of work supporting implementation efforts. This includes release of 11 guidances for industry, four of these guidances are final. They cover topics like standards for the interoperable exchange of product tracing information; annual reporting by wholesale distributors and third party logistics providers; product identifier requirements; and identifying trading partners.
Currently, authorized trading partners are exchanging tracing documentation in electronic or paper format. Manufacturers, re-packagers, wholesale distributors, and the dispensers – who are mainly pharmacies – all have systems and processes in place to quarantine and investigate suspicious products. They can then notify trading partners and the FDA when illegitimate products are found. And they can respond rapidly to notifications of illegitimate products.
The Commissioner announced the release of two new draft guidances for industry. The first is titled: Definitions of Suspect Product and Illegitimate Product For Verification Obligations Under the Drug Supply Chain Security Act. The other is Standardization of Data and Documentation Practices for Product Tracing. FDA believes this guidance will help trading partners understand the data elements that should be included in product tracing information. In addition, this guidance recommends documentation practices that trading partners can use to satisfy the product tracing requirements of section 582.
FDA is clear about its expectations regarding interoperability of the enhanced system. In 2023, the current requirement that trading partners share full transaction history for products will sunset. This does not mean that the historical information disappears. An interoperable, electronic system can promptly generate that historical information when needed. The FDA has an obligation to respond rapidly to breaches in the supply chain to protect patients from harmful drugs. FDA can’t fulfill this obligation without essential tracing information about these products in the supply chain.
FDA is not mandating any specific technology for meeting the interoperability standard. Technologies exist, both proprietary and open source, which allow this level of functionality and interoperability in near real time, down to the package level. FDA will work with stakeholders to develop pilots for their implementation. Supply chain stakeholders also have an obligation to identify and prevent the distribution of illegitimate drugs. Gottlieb expects that a “full implementation of the DSCSA will create a safe; secure pharmaceutical supply chain that will pay dividends for decades to come, including enhanced patient confidence.”