The U.S. Food and Drug Administration (FDA) is asking pharmaceutical packaging companies, brand owners and entities engaged at various levels of pharmaceutical distribution to make the prescription-drug supply chain more secure. The mechanism for the work will be a group of pilot projects focusing on drug traceability and verification.
The FDA initiative, which is part of the Drug Supply Chain Security Act (DSCSA), supports development of an improved electronic track-and-trace system for prescription drugs. Scheduled to go live in 2023, the system will reduce drug diversion and introduction of counterfeit products into the U.S drug supply chain, with system users sharing information electronically.
Until March 11, 2019, FDA will be accepting requests from entities within the pharma distribution supply chain to participate in the DSCSA pilot-project program. Participants’ pilot projects will use new and emerging technologies to identify the best processes and attributes for the nascent DSCSA drug-tracing and -verification system.
Answering Packaging Digest’s questions about the pilot-project program is Ilisa Bernstein, deputy director of the Office of Compliance, Center for Drug Evaluation and Research, FDA. For more information about participating in the program, click here.
What does FDA hope to achieve with the DSCSA pilot-project program?
Bernstein: The DSCSA pilot-project program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the interoperable, electronic track-and-trace system to be established by 2023.
How will the pilot-project program improve pharmaceutical track-and-trace?
Bernstein: FDA expects that the pilot projects will:
• aid in identifying the system attributes needed for enhanced package-level product tracing and verification;
• assess approaches to identify, manage and prevent the distribution of suspect and illegitimate product; and
• identify and evaluate efficient ways to electronically exchange product-tracing information across the supply chain in an interoperable manner.
What types of entities are expected to participate in the program?
Bernstein: FDA wants participants from across the pharmaceutical distribution supply chain, including manufacturers, re-packagers, wholesale distributors and dispensers and other stakeholders. FDA would like the pilot projects to reflect the diversity of the supply chain, including large and small entities from all industry sectors.
Is there a maximum number of entities that can participate in the program?
Bernstein: FDA is open to accepting multiple pilot projects that meet the established criteria. FDA will accept as many pilot-project proposals as it can manage.
What types of technology might participants use as the basis for their projects?
Bernstein: FDA is aware that blockchain is one of many technologies that is being researched for product tracing and verification. FDA is open to considering all viable technologies and methods to be included in pilot projects.
What are some examples of practices, processes and systems that ideally will be piloted?
Bernstein: FDA previously held a public meeting in April 2016 to discuss proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.
Participants will test new technologies that can help spur greater accountability and improve FDA’s ability to trace prescription drugs at every point in the supply chain. There are some ideas in Table 1 of the Federal Register notice [with project topics such as product identifiers, bar codes and interoperability], but the program will consider other proposals, as well.
When will the pilot-project program conclude, and when will FDA release a public report summarizing the results of the pilot projects?
Bernstein: The duration of the DSCSA pilot-project program will depend on the pilot project(s) accepted into the program, and when the projects are completed. When the program concludes, FDA intends to issue a final report and post it on our website. That report will include:
• the names and industry sector(s) of the pilot-project participant(s);
• the pilot project’s objectives and evaluation methods;
• the duration of the pilot project; and
• the key findings and lessons learned from the pilot project.
Participants in the DSCSA pilot-project program must start their pilot projects within four months of receiving a letter of acceptance from FDA. How long after they ask to become a participant will they receive an acceptance letter?
Bernstein: FDA is excited about this program and is committed to reviewing the applications in a timely manner. While FDA hopes to contact program participants by early April, the response time will depend on how many requests FDA receives.