U.S. Launches Key Starting Materials Survey, Putting Upstream Drug Supply Risk In Focus

By Elizabeth Urbanek, Executive Editor

The federal government has launched a review of the chemical precursors behind U.S. drug manufacturing. The assessment targets key starting materials (KSMs), the materials used to make APIs, and will survey manufacturers, suppliers, distributors, and buyers across the pharmaceutical supply chain.

Announced Nov. 3, the Department of Health and Human Services' (HHS) Administration for Strategic Preparedness and Response (ASPR) is running the assessment with the Department of Commerce's Bureau of Industry and Security (BIS) and the Department of War's Office of the Assistant Secretary of War for Health Affairs. ASPR said the goal is to identify supply chain vulnerabilities, including limited domestic production and reliance on foreign or single sources, and to inform strategies to strengthen domestic manufacturing.

BIS is collecting the data under its survey authority in section 705 of the Defense Production Act. The one-time survey covers production capabilities, sourcing practices, customers, supply chain disruptions, workforce, and research and development. Findings will feed a report on U.S. KSM production capacity, vulnerabilities, and emergency response capabilities, with recommendations on supply chain resilience. ASPR said the results will help the government develop funding strategies.

The KSM review extends earlier work further upstream. BIS completed a survey of the API industrial base with ASPR earlier in 2026. ASPR has also funded some domestic KSM production, including shikimic acid for the influenza drug oseltamivir and thebaine, a starting material for medicines used in pain management, alcohol use disorder, and opioid overdose reversal.

The announcement does not mention clinical trials or investigational products. It does not list which KSMs or drug classes are in scope, give a survey deadline, say how companies will be selected, or set a date for the final report.

What This Means For Clinical Supply

For clinical supply teams, KSMs usually sit several tiers below the suppliers they manage. Yet the same upstream materials feed small molecule investigational medicinal products (IMPs), comparators, rescue medications, and background therapies. When a KSM source fails, the effect can reach a study as a delayed API batch, a comparator lot that can't be sourced, or a standard-of-care drug in short supply at sites.

Few sponsors can see where their KSMs originate. That information usually sits with chemistry, manufacturing, and controls (CMC) teams and with the CDMOs and API makers behind them. If the assessment leads to funding or sourcing incentives, sponsors could face a tradeoff between established low-cost sources and qualified alternatives. A supplier change mid-development also brings comparability work and regulatory filings.

The survey's scope includes procurers and customers, not only producers, so sponsors and CDMOs that buy APIs or intermediates could receive it. Teams would need to decide who owns the response, since the answers draw on procurement, CMC, quality, and supply planning data that rarely sit in one place. Organizations that receive a request should confirm their response obligations with counsel.

The announcement does not establish what the findings will show, whether funding will follow, or on what timeline. Nothing in it changes current sourcing requirements for clinical supply.

For sponsors, the operational question is whether supply plans for long-running studies still rest on single-country or single-source upstream materials they cannot see, and whether they want to learn that before a federal survey or a shortage tells them.

The Supply Question

Should clinical supply teams invest now in mapping KSM origins for their IMPs and comparators, or rely on CDMO and API suppliers to manage upstream risk until policy direction is clearer?

Related Clinical Supply Leader Editorials:

• What Your Tier 1 Supplier Map Might Be Missing
• Clinical Trial Supply Chains Need To Prepare For A Less Predictable World
• How A Comparator Is Really Bought

About The Author:

Elizabeth Urbanek is the Executive Editor for Clinical Supply Leader, where she works with clinical trial supply and logistics professionals across pharma and biotech to bring real-world perspectives, operational challenges, trends, scientific insights and regulatory strategy to the field.

Before joining life sciences media, Elizabeth spent more than 15 years in broadcast, digital and live-event storytelling, helping highly technical teams communicate complex ideas with clarity and impact. She brings that same approach to clinical supply, creating editorial space for experts to share what is happening across clinical trial operations.

Elizabeth is passionate about connecting people and ideas, identifying emerging themes and showcasing work that can move the clinical supply field forward.