The White House is moving to identify new and unused domestic, US-based, and near-shore production capacity to meet a goal of localizing manufacturing of essential medicines.

By Patricia Van Arnum, Editorial Director, DCAT, [email protected]

Seeking to increase US manufacturing of essential medicines
Onshoring or reshoring of pharmaceutical manufacturing is a policy goal of the current Administration, and the White House took another step late last month (September 2026) for increasing US-based manufacturing for 86 essential medicines, primarily generic drugs.

The Office of Management and Budget (OMB), part of the Executive Office of the President, put out a request for information to identify new and unused (idle) domestic, US-based, and near-shore production capabilities for finished dose forms (FDFs), active pharmaceutical ingredients (APIs), and key starting materials (KSMs) associated with a list of 86 essential medicines identified by the Administration for Strategic Preparedness and Response (ASPR), part of the US Department of Health and Human Services. The list of essential medicines was initiated in the first Trump Administration through Executive Order in August 2020, which directed the US Food and Drug Administration (FDA) to identify a list of essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms. It was in response to potential drug shortages and supply-chain vulnerabilities that arose related to emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological, and nuclear threats to ensure sufficient and reliable, long-term domestic production of these products and to minimize potential shortages by reducing US dependence on foreign manufacturers of these products.

OMB is requesting information from qualified manufacturers within the pharmaceutical, chemical, and petrochemical industries on the availability of US or near-shore production capacity to manufacturing these 86 essential medicines, as well as on two antibiotics, amoxicillin and ciprofloxacin, due to potential supply chain vulnerabilities. Responses to this request for information will be accepted until October 26, 2026, and will be shared with federal agencies that have requirements for essential medicines or responsibilities for strengthening the domestic industrial base for essential generic pharmaceuticals.

The feedback may be used to help inform near-term federal acquisition efforts (both enterprise and government-wide), which might include limiting competition for a federal contract to a particular source or sources to achieve industrial mobilization, and related efforts to inform potential sources of financial assistance. OMB made the request for information in the September 23, 2026, issue of the Federal Register, a publication of the US federal government of proposed and final rulemaking.

Manufacturing, sourcing, and cost information being requested
The information gained from OMB’s request will be used to optimize use of existing US domestic or near-shore capacity and to better understand ongoing or planned actions to create new domestic or near shore-capacity for essential generic pharmaceuticals on ASPR’s list of 86 essential medicines. Schedule 2 controlled substances and branded drugs on the list are not priorities for this request for information. The primary objective is to identify existing and new domestic, US.-based or near-shore production capabilities for FDFs, APIs, and KSMs associated with ASPR 86’s list of essential medicines. OMB is seeking information on all aspects of the manufacturing lifecycle, from raw material sourcing to finished product. This information will be used to shape federal policies, programs and potential partnerships to re-shore production and eliminate supply chain risks.

To facilitate a comprehensive assessment of market opportunities to leverage existing or new capabilities, the US government intends to provide qualified respondents with access to historical federal spend data related to the essential medicines categorized under ASPR’s list of 86 medicines and a comprehensive list of associated APIs and KSMs.

The request for applies to entities that have idle production capacity or are planning new capacity to produce FDFs, APIs, or KSMs on the essential medicines list domestically or at a near-shore location. Respondents are being asked to identify the location of their manufacturing site (s), the available capacity, the amount of current production, amount of unused capacity, and estimated timeline to reach full operational capacity.

With respect to technical capabilities, the request for information is asking respondents to confirm FDF, API, and KSM synthesis or formulation capabilities relevant to a drug(s) on the list of 86 essential medicines. Respondents are also being asked to identify their sourcing strategies, including supply-chain mapping for upstream inputs, including specific countries of origin, as well as information on the demand side for the price per unit needed to operate at full capacity. In addition, the request for information includes a description of financing that may be sought to fill or increase production—debt, equity, offtake contract, or other form of financing, as well as the reason for financing, such as restart costs and additional labor costs to increase productions.

For potential new capacity to produce a drug(s) on the list of 86 essential medicines, the information request includes the location of existing or planned manufacturing site for new production and the status of the site, such as whether it is an existing, brownfield, or greenfield site If not existing, respondents are being asked if funding has been secured for construction and/or renovation. In addition, respondents are being asked to provide the level of planned production and the level of demand and projected cost per unit needed to produce the product and maintain long-term domestic viability of US-based production.