Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS (FASTPASS) Proposer Workshop RFP

Description: The FASTPASS program seeks to prevent contaminated or substandard medications from reaching patients by developing a system, comprised of multiple technologies, to perform rapid, non-contact drug quality and safety testing at points of entry and across the supply chain. American patients deserve to know that the drugs they take meet the quality and efficacy standards that the FDA approved. FDA inspections are still the gold standard for quality assurance, ensuring that U.S. medical products are safe and effective. However, United States depends heavily and increasingly on global pharmaceutical supply chains for key starting materials, active pharmaceutical ingredients, and finished drug products. As this dependence has grown, the challenge of ensuring the quality and safety of imported pharmaceuticals has grown with it. Existing oversight tools—including facility inspections and laboratory-based testing remain essential— but are stretched thin supporting the magnitude and complexity of today’s international supply chains. Consequences of unsafe drugs range from treatment delays, to recalls, to patient death, all of which can be prevented or substantially reduced with increased capabilities for fast and robust testing at ports. New tools and techniques developed by FASTPASS aim to increase the capacity and capabilities to ensure that every dose is right and every dose is safe. See attached file.