US President Donald Trump has signed an executive order to strengthen the American pharmaceutical supply chain resilience by filling the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR).

The Trump Administration originally created the SAPIR in 2020 during his first term to stockpile APIs and ensure domestic sources for essential medicines.

“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 the Key Starting Materials used to make APIs.  Moreover, Government purchases of APIs to fill the SAPIR can encourage more domestic production of APIs,” Trump noted in the order published on August 13 by the White House.

However, he claimed the successive administration failed to advance this goal, despite spending billions of dollars on initiatives to secure supply chains. Domestic production and procurement did not increase, and the SAPIR remains nearly empty

Under the new order, the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services is directed to develop, within 30 days, a list of approximately 26 critical drugs that are deemed vital to the nation’s “health and security.” 

The list will be developed in consultation with agencies with scientific expertise, the Assistant to the President for Economic Policy (APEP), and the Assistant to the President and Homeland Security Advisor (APHSA).

The ASPR will also assess available funds to finance the preparation and opening of the SAPIR repository, as well as obtain and maintain the 6-month supply of APIs for the critical drugs.

The Office of Management and Budget (OMB) will assist the Secretary of Health and Human Services in repurposing funds, consistent with law.

“The ASPR shall place such APIs within the SAPIR repository no later than 30 days after the repository is certified by the ASPR as ready to receive and maintain APIs,” the order said.

In addition, the ASPR is directed to provide an updated version of its 2022 list of 86 essential medicines and medical countermeasures to the APHSA, APEP, and OMB, along with a plan to obtain from domestic manufacturers, where possible.

The plan will also include a proposal and cost estimate for opening a second SAPIR repository in the United States within one year.