Biden-Harris Administration 100 Day Supply Chain Review
HHS Takes Immediate Action to Secure Pharmaceutical Supply Chain
On February 24, 2021 President Biden signed Executive Order 14017 to secure America’s critical supply chains. The Executive Order directed the Administration to immediately launch a 100-day review and strategy development process to address vulnerabilities in the supply chains of four key product categories, including pharmaceuticals. The pharmaceutical supply chain report, led by the Department of Health and Human Services, and its recommendations have been submitted to President Biden and HHS is taking immediate action to secure the pharmaceutical supply chain .
Keeping the Nation’s drug supply chain secure, robust, and resilient is essential for the national security and economic prosperity of the United States.
A robust pharmaceutical supply chain has three critical features:
- the ability to manufacture high-quality products for the U.S. market;
- diversification of the drug supply chain, such as relying on a geographically diverse set of manufacturers; and
- redundancy of the supply chain, such as the existence of multiple manufacturers for each product and its precursors.
The COVID-19 pandemic has shown the importance of a nimble supply chain that is flexible enough to rapidly change manufacturing volumes and products in response to fluctuations in demand during a crisis. As this report details, the pharmaceutical supply chain is complex, global, and vulnerable to disruptions and is highly influenced by certain market factors and policy decisions that have led to an increasing reliance on foreign countries to manufacture the medicines, active pharmaceutical ingredients (APIs) and key starting materials (KSMs) that serve the American public.
HHS recognizes vulnerabilities in our pharmaceutical supply chains and this new report and our recommendations reinforce the need to continue to strengthen our efforts to safeguard them. Our initial supply chain investments established a distributed and highly portable production capability for critical APIs and final formulated medicines. Additionally, we collaborated to develop a continuous manufacturing technology that enables rapid, on-demand, fully automated, production of medicines in a small-footprint facility and transition from synthesis of active pharmaceutical ingredients (APIs) to final formulation without interruption. We also established the consortium for Rapid Aseptic Packaging of Injectable Drugs (RAPID) that will enable the Strategic National Stockpile (SNS) to fill and finish, on a rapid basis, hundreds of millions of pre-filled syringes to respond quickly and efficiently to widespread health emergencies. Finally, we established the Foundry for American Biotechnology to produce technological solutions that help the United States protect against and respond to health security threats, enhance daily medical care, and add to the U.S. bioeconomy. The actions we take moving forward will only further protect the nation’s pharmaceutical supply chains.
Today, the Biden-Harris Administration is announcing a set of actions designed to ensure the U.S. has the pharmaceuticals necessary for economic security, health security, and national defense. These actions center on four pillars:
- Leverage the Defense Production Act and Current Public-Private Partnerships to Establish a Consortium for Advanced Manufacturing and Onshoring of Domestic Essential Medicines Production.
- Special priority should be given to strengthen the supply chain for sterile injectable products which are critical in acute care health care settings.
- Collaborate with allies to develop supply chains that are diverse and complementary.
- Develop fully integrated and smaller footprint platforms that will reduce supply chain demands for raw materials, increase domestic pharmaceutical manufacturing surge capacity, and more broadly improve technological capabilities that can lead to the manufacturing of APIs and supportive care fluids.
- The Department of Health and Human Services will make an initial commitment of $60 million in funding from the American Rescue Plan to develop novel platform technologies to increase domestic manufacturing capacity for API. Greater API production domestically will help reduce reliance on global supply chains for medications that are in shortage, particularly during times of crisis.
- HHS will also develop a strategy for facilitating a wider adoption of novel methods for commercial production of pharmaceuticals and biologics.
Recognize and reward manufacturers for mature quality systems that focus on continuous improvement, business continuity plans, and early detection of supply chain issues.
Establish new initiatives to collect additional supply chain data to improve proactive surveillance, oversight and supply chain resiliency.
To achieve success, this effort requires the support of various U.S. government entities that are committed to providing Americans with timely access to pharmaceuticals, promoting our economic well-being and emphasizing the role these activities play in shoring up our health security and national defense.