Strengthening the U.S. Pharmaceutical Supply Chain's Stability Through Stockpiling Critical Drug Ingredients
In a continuation of initiatives started by the Trump Administration, the Biden Administration has taken steps to strengthen the resilience of pharmaceutical supply chains in the United States.
Back in 2020, President Trump issued Executive Order 13944, aiming to combat public health emergencies by ensuring essential medicines and medical countermeasures are made domestically. This order directed agencies to increase domestic procurement of these medicines and identify vulnerabilities in the supply chain. Despite these efforts, as of 2025, only about 10 percent of Active Pharmaceutical Ingredients (APIs)—the biologically active components of drugs—used in the U.S. are produced domestically, though nearly 40 percent of finished prescription drugs are made in the U.S.
The Trump Administration also established the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to stockpile APIs, enhancing supply chain resilience.
The Biden Administration has built upon these foundations, issuing further executive orders to promote domestic production of critical medicines and filling strategic reserves. In August 2025, a new order was issued, directing the Office of the Assistant Secretary for Preparedness and Response (ASPR) to maintain a 6-month supply of APIs for drugs on the updated essential medicines list. The ASPR was also instructed to provide an update to the list of 86 essential medicines and a plan to obtain and store these medicines from domestic manufacturers, where possible, within 90 days.
The Food and Drug Administration published a list of Essential Medicines, Medical Countermeasures, and Critical Inputs in October 2020. The location of the second proposed SAPIR repository, where the stockpiled APIs will be housed, is not specified in the order.
The costs for publication of the order are to be borne by the Department of Health and Human Services. It's important to note that the order does not create any right or benefit enforceable at law or in equity by any party, and only affects the authority granted by law to an executive department or agency, or the head thereof. The functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals are not affected by the order.
This evolution in policy illustrates a bipartisan and escalating focus on securing pharmaceutical supply chains by increasing domestic production and stockpiling critical materials, addressing vulnerabilities exposed during the COVID-19 pandemic and related public health emergencies. The new order aims to further improve supply chain resilience and ensure a more robust response to future crises.
- To ensure a healthier nation and mitigate potential future crises, the Biden Administration has directed the Office of the Assistant Secretary for Preparedness and Response (ASPR) to focus on health-and-wellness by securing a 6-month supply of Active Pharmaceutical Ingredients (APIs) for drugs on the updated essential medicines list, prioritizing domestic production where possible.
- In a bid to foster domestic production and bolster financial stability, the Biden Administration has issued a new executive order, aiming to finance the domestic production of critical medicines and strategically filling reserves, thereby fostering resilience in both the pharmaceutical supply chain and the financial sector.
