HHS’ Administration for Strategic Preparedness and Response, the Commerce Department’s Bureau of Industry and Security and the Department of War’s health affairs office are assessing the U.S. industrial base for pharmaceutical key starting materials. The materials are the chemical precursors and intermediates used to make active pharmaceutical ingredients.
The assessment will examine the upstream supply chain behind U.S. drug manufacturing, including limited domestic production capacity and reliance on foreign or single sources of critical materials, according to a Nov. 3 news release. BIS is surveying U.S. manufacturers, chemical suppliers, distributors, procurers and customers under Section 705 of the Defense Production Act. The one-time survey collects information on production capabilities, sourcing practices, customers, supply chain disruptions, workforce and research and development.
The findings will be compiled into a report on U.S. production capacity, supply chain vulnerabilities and emergency response capabilities, with recommendations to improve resilience and public health emergency preparedness. The government plans to use the findings to develop funding strategies for the availability, quality and security of the materials.
The assessment supports the goals of President Trump’s Executive Order 14336, which directed the government to fill the Strategic Active Pharmaceutical Ingredients Reserve with a six-month supply of ingredients for about 26 critical drugs, subject to available funding. ASHP has said the reserve is not expected to change sourcing or pricing for pharmacies immediately but could help maintain supply during a disruption. The administration is also developing an initiative to move production of 86 essential medicines to the U.S. within 18 months.
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