Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study
NEW HAVEN, Conn., Aug. 8, 2023 /PRNewswire/ — Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order 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. This 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 much-needed transparency in drug quality, this study will enable conscientious manufacturers to be able to better compete and allow major purchasers of drugs, like the Department of Defense and Veterans Administration, 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 United States 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 rampant drug shortages, approximately 76% of which are due to manufacturer quality problems, roughly 3 drug recalls per day in the United States, 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.”
Representative Rosa DeLauro (D-CT), a member of Congress for the past 32 years and Ranking Member of the House Appropriations Committee, commented, “This study will allow the DoD, a major purchaser of drugs, to ensure those manufacturers, who are in compliance with U.S. health and safety standards and routinely assure the quality of their drugs, are rewarded for doing the right thing. In addition, it will ensure our men and women in uniform have access to safe and secure medicines. It’s the least we can do for those who put their lives on the line. Our country’s reliance on active pharmaceutical ingredients and medicines manufactured abroad in China and India has come at significant cost of safety, as drug quality is the main reason for drug shortages. I am committed to investing in long-term solutions to increase domestic pharmaceutical manufacturing”
Representative Neal Dunn, MD (R-FL), a former US Army surgeon and member of the China Select Committee, commented “Our veterans and servicemembers deserve ample access to safe, generic medications. This agreement provides the Department of Defense with quality data and much-needed transparency that will benefit our brave men and women in uniform. When it comes to the health and safety of our military, ensuring we have a plentiful and safe supply of life-saving prescription drugs and treatments at an affordable price is a matter of national security.”
Bi-partisan support in Washington has been growing for taking action on improving drug quality, addressing drug shortages and specifically for independent chemical testing of generic drugs. Representatives DeLauro and Dunn co-lead a proposed amendment to the NDAA which stipulated that certain drugs with high quality concerns could be “tested and certified as safe by an accredited independent laboratory which tests pharmaceutical agents and their active pharmaceutical ingredients and certifies their safety.” The proposed amendment defines an “accredited independent laboratory” as “a facility accredited to ISO 17025 or equivalent standards” and that has “no conflicts of interest.” This is a policy closely aligned with the European Directorate for the Quality of Medicines & Healthcare and its network of Official Medicines Control Laboratories (OMCLs) that “By testing medicines independently of manufacturers (that is, without conflicts of interest and with guaranteed impartiality), the OMCLs have a fundamental role in ensuring the quality, safety and efficacy of medicines.”
In this Defense Department collaborative study, quality will be assessed through a robust, 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.” Adds David Light, Chief Executive Officer 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.”
US Army Colonel, Victor Suarez and David Light, are co-presenting a learning lab session at The Association for Healthcare Resource & Materials Management (AHRMM) Annual Conference on August 8th, 2023. During their session, titled “Drug Shortage, Safety, Quality & Effectiveness Crisis: A Quadruple Threat to Healthcare & National Security,” attendees will be given a background and landscape description of why the US is experiencing drug shortages and diminishing confidence in the quality, safety, and effectiveness of our drug supply, and discuss how healthcare leaders may mitigate these challenges.
Any entities interested in collaborating on this project can contact Valisure at [email protected].
About Valisure
Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and quality issues in the global supply chain, Valisure’s team of Harvard– and Yale-trained scientists developed proprietary analytical technologies to independently test products, identify critical issues, and offer services to help distinguish quality stakeholders and products. Valisure’s novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and private industry to help improve public health. For further information, please visit www.valisure.com and follow us on Twitter and Instagram.
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