The order is part of a push to reduce U.S. dependency on adversary nations for key raw materials needed to make medicines, according to the White House.
WASHINGTON—President Donald Trump signed an executive order on Aug. 13 to enhance American drug supply chain resilience by filling and maintaining the strategic reserve for essential pharmaceutical ingredients, with a preference for American-made ingredients—a move designed to push production away from dependency on China-made ingredients.
“Nearly two-in-five prescription finished drug products are made in the United States, including many of the essential medicines,” the president’s executive order stated. “However, when it comes to Active Pharmaceutical Ingredients (APIs), the biologically active components of finished drug products, only about 10 percent of the APIs by volume for the finished drug products used in the United States are made here.”
Trump ordered the rapid restocking of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a program he created in his first term to stockpile APIs. He criticized the Biden administration for leaving the reserve nearly empty.
Under the new order, the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services has 30 days to identify what is estimated to be roughly 26 drugs considered critical to the nation’s health and security.
Within 120 days, the agency must prepare the existing Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to begin receiving and storing these APIs.
The ASPR is directed to secure a six-month supply of the ingredients needed to produce critical drugs, prioritizing domestically manufactured sources, if possible.
The plan also includes a proposal and cost estimate for opening a second strategic reserve site within one year.
“Stockpiling APIs is advantageous as APIs are generally lower-cost and have longer shelf lives than the finished drug products they make,” according to the executive order. “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.”
The president’s order aims to encourage more domestic production of APIs.
By Emel Akan
