Roughly three months after signing an executive order to streamline the construction of drug manufacturing plants in the U.S., President Donald Trump has issued another directive aimed at shoring up the country’s pharmaceutical supply chain.
Trump on Wednesday inked a new order calling on the Department of Health and Human Services’ (HHS') Administration for Strategic Preparedness and Response (ASPR) to identify and stockpile active pharmaceutical ingredients for roughly 26 medicines the agency deems essential.
The ASPR will have 30 days to develop the roster of drugs that are “especially critical to the health and security interests of the nation,” according to an Aug. 13 White House release.
In the longer term, the agency will also be tasked with figuring out how to leverage existing funds to obtain and maintain a six-month supply of the chosen APIs for the country’s Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), which was formed under Trump during his first term.
The agency is being instructed to prioritize sourcing of the APIs from U.S. manufacturers, where possible.
“Stockpiling APIs is advantageous as APIs are generally lower-cost and have longer shelf lives than the finished drug products they make,” the executive order states. “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.”
Further, the order contemplates that government purchases of APIs to fill up the national stockpile could encourage more companies to produce drug ingredients on U.S. soil. Only about 10% of APIs by volume for drugs used in the U.S. are produced in-country, the White House said in a fact sheet accompanying the executive order.
Focused on restoring the U.S.’ manufacturing base in both his first and second terms, Trump previously established the SAPIR in 2020. In 2022, the ASPR refined a list of essential medicines from the FDA down to 86 drugs to prioritize in an “enhanced onshoring effort.”
But Trump now argues that enough work was not done by the previous administration to ensure domestic sourcing for those critical drugs.
Aside from the new list of 26 essential medicines the ASPR will have to build, the agency is also on the hook to update its 2022 list of 86 critical drugs and provide a plan to source and stockpile a continuous six-month supply API for them, too, the order states.
The directive is the latest in a series of manufacturing-focused moves by the second Trump administration.
Back in May, Trump signed a separate order commanding the FDA to reduce the amount of time it takes to approve domestic drug manufacturing plants while simultaneously increasing fees and inspections for foreign facilities.
Subsequently, the FDA last week unveiled its new PreCheck program, which aims to streamline U.S. drug plant build-outs by boosting early communication and feedback with the regulator around areas like facility design, construction and chemistry, manufacturing and controls (CMC).
Elsewhere, the HHS, the ASPR and the U.S.’ Defense Advanced Research Projects Agency linked up with multiple companies and universities in mid-May to improve domestic drug manufacturing through the deployment of newer technologies like artificial intelligence, machine learning and informatics.
All of this has come against the backdrop of Trump’s incessant threats of sector-specific import tariffs on pharmaceuticals, which the president most recently said could start at a small rate before increasing to 150% and then 250% if drugmakers don’t play ball by shifting production to the U.S.
Although the industry has largely been in a holding pattern around tariff threats, the prospect of pharmaceutical trade duties has encouraged many large pharma companies to make investments in their U.S. operations. The focus of those projects has occasionally extended to API manufacturing.
When Eli Lilly said it would invest $27 billion in its U.S. manufacturing earlier this year, the company drafted plans to build four new factories, three of which will focus on drug ingredients.
Meanwhile, after telegraphing a $10 billion U.S. investment in April, AbbVie earlier this week said it would use $195 million from that tranche to construct a new API production plant in North Chicago. AbbVie aims to start construction in the fall, with the goal of getting the facility up and running by 2027.