The U.S. House of Representative’s Energy and Commerce Committee’s Subcommittee on Health recently held a hearing to discuss how we can manufacture more medicines and their ingredients in the U.S. to build a more resilient and reliable supply chain. The hearing, titled “Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain,” brought together bipartisan voices and expert witnesses to address this challenge. I testified before the subcommittee along with four other witnesses, including representatives from USP Convention Member Organizations, who contributed valuable and complementary perspectives.
Medicines supply chains are geographically concentrated and fragile
Globalization has enabled the manufacture of generic medicines at lower cost. However, it has also made our supply chains longer, more fragmented, and opaque.
In my testimony, I shared insights from USP’s Medicine Supply Map, a data intelligence platform that tracks 94% of U.S. drug products and ingredients. Some striking findings have emerged from this extensive mapping. For example, more than 70% of active pharmaceutical ingredients (APIs) used in U.S. medicines are manufactured abroad, often concentrated in just a few locations. This geographic clustering creates significant supply chain vulnerabilities, especially for essential generic medicines.
Making the U.S. medicines supply chain more reliable and secure
Informed by these insights, we offered four recommendations to guide policymakers’ efforts to support domestic manufacturing:
- Continuously identify the nation’s most vulnerable medicines
- Identify alternative routes of synthesis for vulnerable medicines to identify ways to produce them using key starting materials (KSMs) that are available in the U.S. or multiple geographies. Leverage advanced pharmaceutical manufacturing technologies for more efficient production of these medicines.
- Establish a resiliency benchmark for the purchase of vulnerable medicines, enabling private and public sector purchasers to value resiliency
- Continue to expand supply chain visibility
Our second recommendation, to identify novel routes of synthesis for APIs using alternative KSMs and manufacture them more efficiently with advanced manufacturing technologies (AMTs), resonated with the committee and my fellow witnesses. This recommendation is not just about innovation. It’s about national security, patient safety, and economic resilience. Here’s how it works:
- Current synthesis pathways often rely on KSMs sourced from a single country, creating bottlenecks and geopolitical risks.
- USP’s own chemists have already identified alternative synthesis pathways for critical ingredients such as thymidine, a KSM used in antiviral medicines such as zidovudine, which is used in HIV treatments.
- We are actively optimizing these processes using AMTs. AMTs, such as continuous manufacturing and flow chemistry, offer more efficient, scalable, and distributed production methods. AMTs present an opportunity for manufacturers to potentially produce APIs for vulnerable medicines more cost-effectively within the U.S. when compared to traditional batch manufacturing.
The fragile supply chain is a problem we should solve with confidence
We have a chance to forge a more resilient, adaptable, and secure future for America’s medicine supply. The well-being of millions of people and our nation’s security depends on it.
USP stands ready to work with Congress, industry, and our scientific community to make this vision a reality.
Read our full testimony or watch a recording of the hearing.
