Keeping the U.S. drug supply chain secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States during emergencies like the COVID-19 pandemic and for the provision of day-to-day health care.
On February 24, 2021, President Biden signed Executive Order 14017 to secure America’s critical supply chains. The Executive Order directed the Administration to 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. HHS led the development of a pharmaceutical supply chain report and its recommendations, which were published in a report by the White House on June 8, 2021.
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 active pharmaceutical ingredient (API) supply chain, including facilitating adoption of novel methods for commercial production of pharmaceuticals and biologics.
Executive Order 14017 also directs HHS to develop a 1-year report on supply chains for the public health and biological preparedness industrial base. Work on that report is ongoing and, like the 100-day report, is intended to complement the work conducted pursuant to Executive Order 14001 (A Sustainable Public Health Supply Chain, issued on January 21, 2021). Under EO 14001, HHS is developing a Pandemic Supply Chain Resilience Strategy to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats.
A robust pharmaceutical supply chain has at least 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 [consumer] 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 that have led to an increasing reliance on foreign countries to manufacture the medicines, active pharmaceutical ingredients (APIs) and their key starting materials (KSMs) that serve the American public.
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
- Leveraging data to improve supply chain resilience
FDA plays a critical role in protecting the United States from health threats, including emerging infectious diseases. FDA oversees the Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies.
FDA actively monitors the status of medical products that are in shortage or appear likely to go into shortage. For example, manufacturers of drugs and biologics to treat serious diseases or conditions are generally required to notify FDA of significant manufacturing discontinuances or interruptions. This authority has facilitated FDA’s information gathering activities as FDA continues to remind manufacturers of drugs and biologics of the applicable requirements to notify the FDA of manufacturing discontinuances or interruptions due to the COVID-19 pandemic.
When a potential shortage is identified in the U.S., FDA works closely with manufacturers, supply chain partners, and our HHS partners to mitigate the impact to U.S. patients and health care providers.
For media inquiries about this report, contact: FDAOMA@fda.hhs.gov
For all other questions about this report, contact: AskMCMi@fda.hhs.gov
- HHS fact sheet: HHS Takes Immediate Action to Secure Pharmaceutical Supply Chain (June 8, 2021)
- FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain (June 3, 2021)
- Guidance for Industry: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (May 2021)
- List of Essential Medicines, Medical Countermeasures, and Critical Inputs