Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies

This article was originally published in USP’s Quality Matters Blog

By Anthony Lakavage

Investments to create a more resilient medicines supply chain and prepare for future public health emergencies are among key provisions of the mammoth $1.7 trillion, bipartisan government appropriations bill signed into law in December 2022. They include steps championed by USP and others to increase supply chain visibility, support advanced drug manufacturing technologies, and bolster federal health agencies for the benefit of patients and public health. USP looks forward to working with all stakeholders on implementation of these important initiatives in 2023.

Improved supply chain visibility

Longstanding medicines supply chain vulnerabilities – including those that could result in drug shortages – became even more evident during the COVID-19 pandemic. To help address these concerns, the omnibus legislation calls for 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. The aim is to provide evidence to inform public investment and policy reforms that build medicines supply chain resilience and reduce the potential for disruptions. This includes leveraging data from a range of sources to identify risk indicators and improve demand forecasting and capacity management.

Identification of upstream supply chain risks is also the primary focus of USP’s Medicine Supply Map. Leveraging insights from data on USP standards distribution and usage at more than 22,000 locations worldwide and 40+ external data sets, USP launched the Medicine Supply Map in 2021 to provide an early-warning capability for supply chain vulnerabilities. Powered by more than 250 million data points spanning 92% of generic medicines approved in the U.S., the Medicine Supply Map enhances visibility into the upstream supply chain for active pharmaceutical ingredients, excipients and finished drug products to help governments, manufacturers, distributors and providers identify, characterize and quantify supply chain vulnerabilities, guide risk mitigation strategies and reduce the frequency and duration of potential drug shortages.

The global nature of the medicines supply chain means that events such as emerging public health crises, natural disasters, geopolitical events, or quality-related issues in one part of the world can affect the availability of medicines everywhere. Therefore, ensuring and enhancing visibility into the upstream supply chain – as provided for under this legislation – is critical to supply chain resilience.

Advanced manufacturing technologies

The legislation also calls for HHS to support development and implementation of advanced and continuous pharmaceutical manufacturing technologies through creation of national centers of excellence. When effectively and appropriately applied to the production of certain drug products, advanced manufacturing technologies (AMT) including pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in sourcing and supply chain resilience. Grants provided to the centers of excellence would support technology development, related research, stakeholder collaboration, workforce training, best practices, and implementation of the technology for domestic manufacturing.

USP is working with partners to develop tools – including public quality standards, guidelines and best practices – to help foster adoption of AMT for both innovator and generic drug products. Such products include small molecule medicines, biologics and biosimilars. In addition, we offer a broad range of solutions to assist technology developers and manufacturers considering adoption of AMT, and are prepared to work with the newly created centers of excellence to leverage our capabilities to help embed quality, facilitate translation of AMT research into industry practice, and enhance workforce development.

 Also included in the omnibus is congressional support for FDA’s Emerging Technology Program. The program facilitates stakeholder collaboration and addresses technical and regulatory issues with innovative approaches to drug manufacturing prior to regulatory submissions. The legislation requires FDA to issue guidance regarding requirements for such approaches, and report to Congress on allocation of funds and staff utilization in the program.

Other provisions supporting AMT adoption include creation of an FDA program to designate novel manufacturing methods as AMT so that those methods can qualify for expedited application development and review if they substantially improve the manufacturing process and maintain equivalent or superior drug quality. The legislation also encourages HHS’ Biomedical Advanced Research and Development Authority (BARDA) to support development of novel pharmaceutical manufacturing technologies that aid production of medical countermeasures at lower cost than traditional manufacturing processes, and partner with domestic manufacturers to enhance the capacity to respond to future public health emergencies.

Investments in supply chain resilience

Other noteworthy measures in the legislation aimed at bolstering the medicines supply chain and drug manufacturing include provisions calling for:

• Increased domestic manufacturing for surge capacity and supplies needed to respond to public health emergencies, as well as improved coordination and communication between private sector partners, BARDA, and FDA to ensure such capacity is maintained;
• A study on the feasibility and utility of providing incentives for increased domestic production of specified generic medicines and their active ingredients;
• A report on efforts to ensure robust domestic drug manufacturing and stockpiling, and mitigation of supply chain vulnerabilities;
• Establishment of a medical distribution supply chain task force to help government agencies and distribution experts prepare for the next public health emergency;
• ASPR assessment of the potential to create an Insulin Center of Excellence, in recognition of the importance of developing a domestic supply chain for insulin; and
• Improved efforts to combat antimicrobial resistance and antimicrobial-resistant infections.

Health agency funding

HHS funding to further support health emergency preparedness includes $950 million for BARDA support of medical countermeasures research and development, which is an increase of $205 million compared to the last fiscal year; $965 million for the Strategic National Stockpile, an increase of $120 million; and $335 million for pandemic influenza preparedness, up $35 million. The bill also provides $3.53 billion in discretionary funding for FDA, $226 million more than last year. FDA increases include an additional $26 million for medical product safety, $41 million for food safety activities, $121 million for cross-cutting initiatives supporting both medical and food safety, and $21 million for infrastructure investments, which will further support supply chain resilience.

Other omnibus provisions to bolster health emergency preparedness include requirements for:

• An Office of Pandemic Preparedness and Response Policy within the Executive Office of the President to support and coordinate preparedness and response, and identify related gaps and inefficiencies, including a liaison to work with affected industries;
• National and state-level exercises every five years to identify and address gaps in preparedness and response;
• Annual HHS reports to Congress on the state of public health preparedness; and
• Improving medical countermeasure research coordination among federal agencies.

USP looks forward to working with stakeholders to implement the omnibus provisions in line with the USP mission to improve public health and the supply of quality medicines. USP will also continue to collaborate on policy initiatives that can help advance these goals.

Learn how USP standards and solutions help build a more resilient supply chain for quality medicines.