Valisure, an independent laboratory, entered into a cooperative research and development agreement (CRADA) with the Department of Defense (DoD) to generate objective drug quality data through independent sourcing and testing for metrics that are expected to differentiate the quality of available manufacturers of a given list of drugs. The study is being conducted in response to a mandate in the FY23 National Defense Authorization Act (NDAA), which instructs the DoD to “assess risks to the department’s pharmaceutical supply chain.”

By creating transparency in drug quality, the study will enable conscientious manufacturers to be able to better compete and allow major purchasers of drugs, like the DOD and Veterans Administration (VA), to reward good manufacturers and exclude substandard medicines from being consumed by the military and veterans and serve as a model for broader adoption throughout the U.S. to benefit all American patients.

Over the past few decades, production of most of America’s generic drugs and particularly, the ingredients needed to make them, has moved to India and China where regulation is increasingly difficult. There is growing concern over drug quality and safety, as evidenced by drug shortages, approximately 76% of which are due to manufacturer quality problems, roughly three drug recalls per day in the U.S., often related to dangerous impurities, and a growing number of studies and physician reports of patient harm. To address such issues, the Administration for Strategic Preparedness & Response (ASPR) published the report “Essential Medicines and Manufacturing Resilience Assessment” in May 2022 which recommended to “leverage the federal government’s collective buying power to reform procurement protocols” and “revise purchasing models to increase emphasis on product quality and supply chain resilience, not simply lowest cost.”

In the DoD collaborative study, quality will be assessed through a multi-step process of independently testing the chemical properties of samples of drug products from suppliers to the DoD and objectively scoring the respective National Drug Codes (NDC) of each supplier. Scoring will be conducted according to a recently published paper authored by a consortium of healthcare key opinion leaders, including individuals at Department of Defense, Long Island University, Yale University, Stanford University, Columbia University, Ohio State University, University of Connecticut, University of Utah, NYU Langone, and Cleveland Clinic, titled, “A data-driven quality-score system for rating drug products and its implications for the health care industry.” Scoring NDCs will not only provide a quality risk assessment but do so in a manner that is actionable for both pharmaceutical distribution and contracting.

“We at Valisure are honored to be working with the Defense Department on such a critical study,” said David Light, CEO of Valisure. “We first described this drug quality scoring model as part of our Senate Finance Committee testimony in 2020 and are very excited to put it into practice with the Department of Defense. Beyond the importance this holds for national security, the Department of Defense is also a large health system with millions of patients. Together with private healthcare leaders like Kaiser Permanente that are already utilizing independent testing programs for generic drugs, this DoD initiative can be a powerful model for improving the generic drug market.”