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) released policy recommendations Tuesday to ensure the security of the U.S. pharmaceutical supply chains.
President Joe Biden has accepted the recommendations.
“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.”
The report from the White House, led by the FDA and ASPR, noted that the pharmaceutical supply chain is increasingly reliant on foreign countries to manufacture medicines, active pharmaceutical ingredients (API), and key starting materials that serve the American public.
HHS will make an initial commitment of nearly $60 million from the Defense Production Act appropriation in the American Rescue Plan to develop novel platform technologies designed to increase domestic manufacturing capacity for API, which in turn will reduce reliance on global supply chains for medications.
The report recommends boosting local production and fostering international cooperation, promoting research and development that establishes innovative manufacturing processes and production technologies, creating robust quality management maturity to ensure consistent and reliable drug manufacturing, and leveraging data to improve supply chain resilience.