The White House has issued a new executive order aimed at strengthening the resilience of the American pharmaceutical supply chain by filling the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). The order, signed by President Donald J. Trump on August 13, 2025, seeks to address vulnerabilities in the domestic production of active pharmaceutical ingredients (APIs), which are key components in many essential medicines.
According to the order, “During my first term, my Administration acted to protect the health and security of the American people by restoring capacity for domestic production of essential pharmaceutical products. Executive Order 13944 of August 6, 2020 (Combatting Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States), directed certain executive departments and agencies (agencies) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, as defined in section 7 of that order, and to identify supply chain vulnerabilities. The Food and Drug Administration published a list of Essential Medicines, Medical Countermeasures, and Critical Inputs in October 2020. The Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services later reduced the list to 86 essential medicines.”
While nearly two out of five prescription finished drug products are produced domestically—including many essential medicines—only about ten percent of APIs used in these drugs are made in the United States. This reliance on foreign sources for APIs is seen as a risk to national health security.
The executive order notes that during President Trump’s first term his administration created SAPIR as a stockpile for APIs due to their lower cost and longer shelf life compared with finished drugs. The goal was also to reduce dependency on foreign suppliers for critical materials needed for medicine production.
“Stockpiling APIs is advantageous as APIs are generally lower-cost and have longer shelf lives than the finished drug products they make. Filling the SAPIR will also insulate the United States from the concentration of foreign, sometimes adversary, nations in the world-wide supply of Key Starting Materials used to make APIs. Moreover, Government purchases of APIs to fill the SAPIR can encourage more domestic production of APIs,” according to President Trump.
However, he criticized subsequent efforts under President Biden’s administration: “Unfortunately, the Biden Administration failed to advance the goal of ensuring domestic sources for essential medicines and their precursors despite spending billions of dollars on efforts to secure supply chains. Domestic production and procurement did not increase and the SAPIR is nearly empty.”
The new directive orders several steps:
- Within thirty days ASPR must develop a list—working with other federal agencies—of approximately twenty-six especially critical drugs.
- ASPR must account for available funds that can be repurposed towards preparing SAPIR facilities.
- Within one hundred twenty days ASPR must ready existing repositories so they can start receiving API stockpiles.
- Subject to available funding identified earlier in this process ASPR is instructed “to obtain a six-month supply” with preference given where possible “for obtaining domestically manufactured APIs.”
- Updates on an expanded list covering eighty-six essential medicines will be provided within ninety days along with plans—including cost estimates—for opening an additional repository within one year.
The order emphasizes that all actions should comply with existing law; it does not create any new rights enforceable against government entities or officers.
“Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive department or agency...; or (ii) the functions of the Director of OMB relating to budgetary,...or legislative proposals,” it states.
Publication costs related directly back into Department Health & Human Services budgets per section four.
