Rockville, MD, January 3, 2022 – The U.S. Pharmacopeia (USP) today issued the following statement from CEO Ronald T. Piervincenzi, Ph.D., on the passage of fiscal year 2023 omnibus government funding legislation:
“USP applauds the investments in the bipartisan funding bill to help ensure a more resilient supply chain for the medicines on which patients rely.
“Although pharmaceutical supply chains proved more resilient than those of many other products during the COVID-19 pandemic, longstanding vulnerabilities – including the potential for drug shortages – were made more evident. The global nature of the pharmaceutical supply chain means that events such as natural disasters, geopolitical events, emerging public health crises, or quality-related issues in one part of the world can affect the availability of medicines everywhere.
“Among other efforts, ensuring and enhancing visibility into the upstream medicines supply chain remains critical to helping governments, manufacturers, distributors, and providers identify and address supply chain vulnerabilities, lessen quality risks, reduce the frequency and duration of potential drug shortages, and protect patients.”
As noted in an explanatory statement for the Bill, the spending package includes language urging the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR) to prioritize identification of upstream pharmaceutical supply chain risks to reduce medicines supply disruptions while also providing evidence to inform public investment and policy reforms that build more resilience in the medicines supply chain. This includes the ability to leverage integrated data analytics from a range of data sources to identify key risk indicators and improve both demand forecasting and capacity management.
Also included are provisions to create national centers of excellence to support implementation of advanced and continuous pharmaceutical manufacturing technologies in the U.S., bolster HHS pandemic preparedness efforts, and increase FDA funding for medical product and food safety initiatives, which will further support supply chain resilience.
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide.