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House subcommittee hears bipartisan concerns over U.S. dependence on foreign drug supply chains
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Summary
A House Energy and Commerce subcommittee hearing spotlighted risks in the U.S. pharmaceutical supply chain, with witnesses and members urging long-term federal purchasing, inspection capacity and targeted incentives to rebuild domestic production of APIs, key starting materials and finished medicines.
A House Energy and Commerce Subcommittee on Health hearing on June 25 examined vulnerabilities in the U.S. drug supply chain and possible fixes, with lawmakers and industry witnesses warning that reliance on foreign manufacturers — particularly upstream suppliers in China and India — threatens public health and national security.
The session opened with Chairman Buddy Carter saying, “The United States should never be dependent on the Chinese Communist Party for the antibiotics and essential medicines,” and continued with testimony from domestic manufacturers, trade groups and standard-setting bodies about concentrated production of active pharmaceutical ingredients (APIs) and key starting materials (KSMs), dwindling U.S. capacity, and the practical steps needed to restore resilience.
Why it matters: witnesses described a supply chain that is “longer, more fragmented, and more opaque” and identified a set of interlocking problems — low prices for many generics, concentrated upstream production of KSMs, slow permitting and long build times for new plants, and insufficient inspection capacity — that together increase the risk of shortages and unsafe products reaching patients.
Direct evidence and proposals presented included: - Patrick Cashman, president of US Antibiotics, described his Bristol, Tennessee plant as the last end‑to‑end U.S. producer of amoxicillin and urged ‘‘long‑term purchasing agreements’’ and a government antibiotic manufacturing fund to provide predictable demand and finance investment. He said U.S. Antibiotics now has about a 5% market share and that adding shifts and lines could materially increase output within roughly 18–24 months. - The United States Pharmacopeia (USP) reported mapping that shows high geographic concentration of KSMs and APIs; USP recommended creating a resiliency benchmark for purchasers, expanding supply‑chain visibility and investing in advanced manufacturing technologies. - The Association for Accessible Medicines urged a suite of incentives — guaranteed purchase contracts, tax credits, simplified regulatory pathways and funding for domestic API capacity — to make U.S. manufacturing economically viable. - The National Association of Boards of Pharmacy described early results from Pulse, a state‑facing implementation tool under the Drug Supply Chain Security Act (DSCSA) that has already helped detect illegitimate products in the field.
Members on both sides pressed witnesses on practical steps: how quickly domestic capacity can expand, whether FDA inspection capacity is sufficient to ensure quality as production reshoring accelerates, and how federal purchasing and stockpiles should be used to sustain domestic suppliers. Representative Diana DeGette and Ranking Member Frank Pallone raised concerns about proposed FDA staffing cuts and the impact on inspections and approvals, while other members emphasized tax and permitting reforms to speed construction and retrofitting of manufacturing lines.
The hearing included repeated references to existing authorities and tools — the Strategic National Stockpile (SNS), the Pandemic and All‑Hazards Preparedness Act (PAHPA), the Defense Production Act, and the Drug Supply Chain Security Act — as levers to shape demand and support domestic capacity. Witnesses and some members urged long‑term contracts, buy‑American procurement when U.S. capacity exists, and strategic stockpiles that include finished drugs and critical upstream ingredients.
Looking ahead: witnesses stressed that rebuilding domestic capacity will take time and coordinated policy: some reopening or scale‑up can be accomplished in 18–24 months with predictable contracts, while building new API facilities typically takes several years and hundreds of millions in capital. Committee members told witnesses they will press for follow‑up work and written materials; members may pursue legislative fixes on procurement, tax incentives, PBM and reimbursement reforms, and regulatory streamlining.
The hearing produced policy recommendations rather than votes; members said they would submit additional questions for the record and consider legislation to implement purchasing and incentive proposals.
