Biden Administration Recommends Policy Changes to Secure U.S. Pharmaceutical Supply Chain

The White House, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Food and Drug Administration (FDA) today released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report and its recommendations have been accepted by President Biden.

"Last year the American people experienced a widespread and significant shortage of N95 respirators for healthcare workers and masks to protect essential workers and others, and year after year we see shortages of medicines and medical supplies like saline,” said FDA Acting Commissioner Janet Woodcock. “Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country. Now is the right time to take action to keep the U.S. drug supply chain secure and resilient.”

She noted that a secure, resilient supply chain will continually meet the diverse health needs of patients and healthcare providers during emergencies as well as on a daily basis and provide valuable U.S. jobs that bolster our economy.

HHS will make an initial commitment of approximately $60 million from the Defense Production Act appropriation in 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 increased public health need.

The report reveals the pharmaceutical supply chain as complex, global, and highly influenced by market factors 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.

To secure the supply chain, the report’s recommendations center on four pillars:

1. Boosting local production and fostering international cooperation;
2. Promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience;
3. Creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance, and;
4. Leveraging data to improve supply chain resilience.

The report acknowledges that achieving success will require multiple U.S. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals. Successful implementation of the recommendations will promote economic well-being and emphasizes the role these activities play in shoring up U.S. health security and national defense.

Strengthening supply chains may require leveraging existing authorities, such as the Defense Production Act, as well as incentives that recognize and reward manufacturers for quality management maturity systems that focus on continuous improvement, business continuity plans, and early detection of supply chain issues.

The recommendations also recognize that securing the supply chain may require new initiatives to collect specific supply chain data that support the private sector in improving resiliency and reducing the likelihood of shortages, especially during public health emergencies, in order to provide uninterrupted service to their customers.

The report and its recommendations were in response to Executive Order 14017, which President Biden issued Feb. 24 to focus on securing America’s critical supply chains. The executive order directed the Administration to launch an immediate 100-day review and strategy development process to address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals. HHS will work with the private sector and Congress to implement the recommendations and develop a strategy to facilitate adoption of novel methods for commercial production of pharmaceuticals and biologics.

About HHS, ASPR, and FDA:

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats.

The FDA, an HHS division, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.