TECHNOLOGY AREA(S): Bio MedicalOBJECTIVE: Develop a reliable tool to determine the country of origin of active ingredients, raw materials, excipients, and final products of pharmaceutical used in the United States.This tool will be used to analyze and mitigate vulnerabilities that may pose a security risk to the United States.DESCRIPTION: Defense Logistics Agency (DLA) Troop Support (TS) Customer Pharmacy Operations Center (CPOC) topic of interest is research focused on the supply chain of medications for the Department of Defense.The security of the pharmaceutical supply chain directly influences war and peacetime healthcare of approximately 2.2 million warfighters, their families, and retirees.A verifiable reference to identify the country of origin for active pharmaceutical ingredients (API) is not readily available to the Customer Pharmacy Operations Center (CPOC).The production of quality API from a sustainable and secure source is a factor in the availability of medications.Another factor, the consolidation of generic manufacturers and a move to a global supply chain have decreased the number of facilities capable of manufacturing quality pharmaceuticals; thus, reducing capacity and quantities of pharmaceutical produced from diversified sources.These vulnerabilities are a concern for the safety and security of the United States.There are reports that a few nations may control the production of 80% to 90% of the raw materials used in pharmaceuticals.These countries have complex political and contentious trade relationships with the United States, which could threaten the pharmaceutical supply chain in the future.Adding to the complexity of the situation, pharmaceutical manufacturers consider the source of their API/final product manufacture to be trade secrets and not adequately tracked by the Food and Drug Administration (FDA) for the purposes of DoD pharmaceutical acquisition.PHASE I: Phase I – 6 Months $100KThe research and development goals of Phase I should provide a comprehensive analysis of the pharmaceutical supply chain, from creation to completion, in real time.This analysis should identify and track the product from sourcing of the API until the final product is assigned a National Drug Code (NDC).The expectation of Phase I is to develop a concise set of data points that can identify the country of origin for key raw materials, excipients used to synthesize the medicines, and the site of final formulation.This data will be the foundation for the prototype tool developed in Phase II. PHASE II: Phase II – 24 Months $1.6MBased on the research and development results, this information will be incorporated into daily operations and strategic planning to adequately analyze and formulate mitigation strategies for potential security risks.The intent is to have a tool that easily and quickly maps the supply chain of raw materials to identify vulnerabilities throughout the pharmaceutical supply chain.In addition, sourcing and flow of materials should allow educated predictions to determine the risk to the supply chain during a time of high demand or in response to a contingency, such as a military conflict, outbreak, earthquake, hurricane, or any other natural disaster.Note, this data highly correlates with Trade Agreements Act (TAA) compliance, but its applications would extend beyond simply tracking the Country of Origin (COO) for the purposes of the TAA compliance.The expectation of the Phase II effort is to have a Prototype tool that easily and quickly maps the supply chain of raw materials to identify vulnerabilities throughout the pharmaceutical supply chain.
PHASE III: The successful offeror should expect to maintain this tool in sustainment for 5 years.This will occur in the form of a follow-on Phase III contract initiated by the Customer Pharmacy Ops Center (CPOC).COMMERCIALIZATION:The progression of information would stream throughout the whole of government based on memorandum of understandings and relationships with the DLA Troop Support.Examples, but not limited to, are Force Health Protection, Readiness, and the Defense Health Agency.
KEYWORDS: Pharmaceuticals, API, active pharmaceutical ingredients, Country of Origin, Trade Agreements Act, TAA, SecurityReferences:
1. Federal Acquisition Regulation (FAR) 52.225-5, Trade Agreements. https://www.acquisition.gov/content/52225-5-trade-agreements#i10536482. Defense Health Agency Procedural Instruction Number 6025.31. December 20, 2019.3. Defense Logistics Agency: DLA Troop Support Medical. https://www.dla.mil/TroopSupport/Medical.aspx
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