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Executive Order 14017 on America’s Supply Chains

USG strategies to help strengthen U.S. supply chain resilience

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Vials representing pharmaceutical manufacturing

 

Introduction

Keeping U.S. medical product and food supply chains secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States, including during emergencies like the COVID-19 pandemic. As part of our vital mission to protect and promote public health, FDA plays a critical role in this effort, including by overseeing the regulation of a majority of the Nation’s medical and food products.

On February 24, 2021, President Biden signed Executive Order 14017 to secure America’s critical supply chains. The Executive Order directed the Administration to: (1) launch an immediate 100-day review and strategy development process to identify and address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals and active pharmaceutical ingredients (API); and (2) submit sectoral supply chain assessment reports within one year of the date of the order, including a report on supply chains for the public health and biological preparedness industrial base and a report on supply chains for the production of agricultural commodities and food products. 

HHS Releases White Paper Focused on Preventing Drug Shortages (April 2, 2024)

Building on the Administration's supply chain efforts, on April 2, 2024, the U.S. Department of Health and Human Services (HHS) released a white paper highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. 

Through the Assistant Secretary for Planning and Evaluation (ASPE), Administration for Strategic Preparedness and Response (ASPR), FDA, the Centers for Medicare & Medicaid Services (CMS), and others, HHS has been working to improve how the department monitors the pharmaceutical supply chain and responds to disruptions.

The white paper focuses on the generic sterile injectable (GSI) drugs that form the basic layer of hospital care and make up the majority of shortages – which occur across therapeutic areas. However, HHS recognizes that these challenges affect other medical products, and expects the concepts and solutions that this white paper discusses may be relevant for other markets as well. 

Read a summary of the white paper, "Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States," or view the full PDF (566 KB). 

Related links from FDA:

Essential Medicines Report (May 23, 2022)

On May 23, 2022, HHS ASPR released the nation’s first Essential Medicines Supply Chain and Manufacturing Resilience Assessment by the U.S. government. The assessment addresses pharmaceutical supply chain constraints identified in the Biden-Harris Administration’s 100-day supply chain review report, specifically those constraints affecting critical medicines on the FDA’s essential medicines list. 

The action plan was developed by National Forum to Secure America’s Supply Chain, led by ASPR and a non-government organization, ARMI’s Next Foundry for American Biotechnology, and includes a prioritized list of medicines that the government can target for increased resilience to overcome current pharmaceutical supply chain challenges and constraints.

This report offers prioritized strategies and implementation actions to increase supply chain resilience—by addressing challenges and constraints—for the essential medicine supply chain. Learn more and download the full report here.

One-Year Report on the Public Health Supply Chain and Industrial Base (February 24, 2022)

Executive Order 14017 directed HHS to develop a one-year report on supply chains for the public health and biological preparedness industrial base. Like the 100-day review, the one-year report is intended to complement the work conducted pursuant to Executive Order 14001 (A Sustainable Public Health Supply Chain, issued on January 21, 2021). 

HHS led the development of the Public Health Supply Chain and Industrial Base One-Year Report, which was published by HHS on February 24, 2022, and identifies practical strategies the U.S. Government can implement to address public health supply chain and industrial base vulnerabilities. The report covers personal protective equipment (PPE) and durable medical equipment, testing and diagnostics, and pharmaceuticals and vaccines. Each section:

  • includes a discussion of pertinent raw materials, as appropriate; 
  • describes the current status of the relevant supply chain and industrial base; and 
  • explains the Department’s current and planned efforts to address these issues and to build and sustain U.S. preparedness and response capabilities for future pandemics. 

The report also identifies the actions HHS has taken to implement the recommendations laid out in the National Strategy for a Resilient Public Health Supply Chain (PDF, 1.4 MB, July 2021) under Executive Order 14001 to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats. For more information, see the HHS news release: HHS Secretary Becerra Highlights Progress Made in Strengthening U.S. Medical Supply Chain and Industrial Base.

One-Year Report on Agri-Food Supply Chains (February 24, 2022)  

Executive Order 14017 also directed USDA to develop a one-year report on supply chains for food and agriculture. The USDA Agri-Food Supply Chain Assessment: Program and Policy Options for Strengthening Resilience provides an assessment of risks and resilience of U.S. agri-food supply chains and identifies potential solutions to address vulnerabilities. Given FDA’s role in regulating about 78 percent of the U.S. food supply, FDA will collaborate closely with USDA and other Federal partners to advance key actions recommended in the report (PDF, 15 MB).  

100-Day Review of Pharmaceuticals and API (June 8, 2021) 

On June 8, 2021, as part of the Executive Order effort, the Biden-Harris Administration announced a set of actions designed to ensure the U.S. has access to the pharmaceuticals necessary for economic security, health security, and national defense. These actions are centered on four pillars:

  • boosting local production and fostering international cooperation;
  • promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience;
  • creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and
  • leveraging data to improve supply chain resilience.

HHS led the development of the 100-Day Review of Pharmaceuticals and API, which was published in a report (PDF, 6 MB) by the White House on June 8, 2021. An HHS summary of the review can be found here. HHS and FDA will work with the private sector and Congress to implement the recommendations and develop a strategy to create a robust and resilient pharmaceutical and API supply chain, including facilitating adoption of novel methods for commercial production of pharmaceuticals and biologics.

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 [consumer] demand during a crisis. As this review details, the pharmaceutical supply chain is complex, global, and vulnerable to disruptions and is highly influenced by certain market factors that have led to an increasing reliance on foreign countries to manufacture the medicines, API, and their key starting materials (KSMs) that serve the American public.

Contact FDA

For media inquiries about these reports, contact: FDAOMA@fda.hhs.gov 

For all other questions about these reports, contact: AskMCMi@fda.hhs.gov   

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