Editor’s (re)View: Trump seeks supply chain resilience for certain drug APIs. What about auxiliary chemicals?
As the industry waits with bated breath for the White House’s threatened tariffs on pharmaceuticals, President Trump this week made another push to increase domestic drug manufacturing and decrease America’s reliance on overseas supply chains.
On Wednesday, Trump ordered the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) to identify approximately 26 drugs critical to U.S. health and security, secure a six-month supply of active pharmaceutical ingredients (APIs) for the drugs, and prioritize domestic sourcing where possible.
Stockpiling APIs for essential medicines seems like a prudent initiative, given that only about 10% of the APIs by volume for finished drug products used in this country are made here, according to Trump’s Aug. 13 executive order.
Wednesday’s move harkened back to the first Trump administration’s efforts to reshore pharmaceutical supply production and reduce dependency on foreign countries for critical drugs. However, that 2020 executive order specifically called out the need to “create, maintain, and maximize domestic production capabilities for critical inputs” including raw or intermediate material used in the manufacturing of APIs.
A recent analysis by United States Pharmacopeia (USP) found that only 12% of total API volume is made in the U.S. While China contributes 8% of the total volume of API, USP discovered “case-by-case evidence of significant dependence on China” for key starting materials (KSMs), the building blocks of APIs.
KSMs are needed to manufacture APIs, which in turn are necessary — along with excipients and other materials — to make a finished drug product. For small molecule drugs, API production includes a multi-step process that starts with the preparation of KSMs and performing controlled chemical synthesis through a series of reactions that use auxiliary chemicals.
In a July 28 analysis, Brookings Institution senior fellow Marta Wosińska and senior research assistant Yihan Shi discussed the critical role China plays in auxiliary chemicals, such as the production of reagents and solvents.
“These chemicals are necessary for the chemical synthesis of API and intermediates yet are omitted from virtually all analyses,” Wosińska and Shi wrote. “Auxiliary chemicals should be included in vulnerability assessments for essential medicines and considered in any stockpiling programs of precursors.”
They concluded that “onshoring active ingredient production will not address the risk unless access to raw materials is also derisked” and “policy interest should be broadened from KSMs to auxiliary chemicals that are needed in the chemical synthesis of API or as excipients.”
Enabling economically viable domestic production of prioritized APIs, KSMs, and auxiliary chemicals are elements of a comprehensive strategy needed to boost U.S. drug supply chain resiliency.
