⚡️ NIMITZ HEALTH NEWS FLASH ⚡️ 

“Made in America: Restoring Trust in Our Medicines”

Senate Special Committee on Aging

November 19th, 2025 (recording linked here)

WITNESS & TESTIMONY

• Tom Neely: Chairman of the Board, Oxford Pharmaceuticals

• Allan Coukell: Chief Government Affairs & Public Policy Officer, CivicaRx

• Patrick Cashman: President, USAntibiotics, LLC

• Eric Edwards, MD, PhD: CEO, PHLOW-USA

HEARING HIGHLIGHTS

MEMBER OPENING STATEMENTS

• Chair Scott (R-FL) emphasized that generic drugs had been a lifeline for millions of Americans but warned that over-reliance on foreign active pharmaceutical ingredients, including from adversarial nations like China, had created dangerous vulnerabilities in the drug supply. He argued that the lack of country-of-origin labeling and weak oversight had contributed to contaminated products, recalls, and shortages, and said it was unacceptable for the United States to be unable to guarantee a safe, steady supply of basic medicines. He called for bringing manufacturing back to the United States, reforming FDA red tape, and changing federal procurement rules so that major government purchasers prioritize safe, reliable, American-made generics instead of simply choosing the cheapest foreign bids. He framed domestic drug manufacturing as both an economic opportunity that creates good-paying jobs and a national security imperative.

• Ranking Member Gillibrand (D-NY) stressed that older Americans, including tens of millions of Medicare Part D enrollees, depended heavily on generic drugs, yet faced chronic shortages and quality concerns. She highlighted a constituent’s experience of being unable to obtain a generic medication for weeks, describing how shortages forced patients to spend time chasing prescriptions, pay extra for help, and endure worsening health and stress. She noted steep declines in U.S. facilities producing finished generic drugs and active pharmaceutical ingredients, and explained that growing dependence on India and China, combined with geopolitical instability and limited oversight, had created serious vulnerabilities for public health and national security. She called for targeted investments in U.S. biotechnology and manufacturing, along with reforms to fix the “race to the bottom” in generic pricing that pushed production overseas, and said she looked forward to working with Chairman Scott and relevant committees to strengthen the generic drug supply.

WITNESS OPENING STATEMENTS

• Mr. Coukell explained that Civica Rx prioritized U.S. sourcing, operated its own state-of-the-art sterile injectable facility in Virginia with a no-China policy in its supply chain, and used rigorous quality oversight including in-person audits. He stressed that very low generic prices, particularly for injectable drugs selling for under one dollar per vial, made U.S. production often financially unsustainable despite high capital and operating costs. He argued that if the country wanted sustainable domestic manufacturing, it had to accept slightly higher prices and reward hospitals that consider quality, domestic sourcing, and buffer inventory, alongside federal investments and policies that create a viable market for finished drugs in the United States.

• Mr. Neely described Oxford Pharmaceuticals’ investment of $130 million in a world-class facility that transformed raw ingredients into finished tablets under strict, end-to-end cGMP quality processes, yet operated in a market dominated by heavily subsidized Chinese and Indian manufacturers and intermediaries focused only on price. He warned that offshore manufacturing had dangerously weakened the supply chain, that many foreign plants went years without FDA inspection, and that Oxford currently ran at only 55 percent capacity despite being the sole U.S. owned manufacturer for many of its products. He urged Congress to treat generics as a national security industry, prioritize legitimate domestic manufacturers in federal procurement, support domestic manufacturing and API production with grants and tax incentives, and require full country-of-origin labeling so patients knew where their medicines were made.

• Mr. Cashman recounted how subsidized competition from India and China had driven the Bristol plant into bankruptcy by 2020, leaving the United States entirely dependent on foreign sources until American investors revived the facility in 2021, restoring domestic capacity for this critical antibiotic. He stressed that seniors used antibiotics at much higher rates and that surgery, cancer treatment, and common infections depended on reliable access, yet most amoxicillin on U.S. shelves now reflected Chinese chemistry finished in India while his company held only about 5 percent of the market despite being able to supply all national demand. He urged Congress to create procurement pathways for domestic manufacturers regardless of parent company size, redefine “domestic” to exclude simple repackaging, prioritize genuine U.S. producers in strategic stockpiles, and offer long-term purchasing agreements.

• Dr. Edwards argued that fragile foreign supply chains and dependence on adversarial nations represented not only a public health problem but also a national security threat, comparable in urgency to rare earths, since APIs underpinned the entire pharmaceutical system. He concluded that onshoring remained fragile without predictable multi-year demand, stronger procurement and pricing incentives for domestic production, a level playing field against subsidized foreign competitors, and closure of loopholes that mislabel foreign APIs as “Made in America,” warning that failing to act would make future crises inevitable while success would restore a critical pillar of national resilience.

QUESTION AND ANSWER SUMMARY

• Sen. Johnson (R-WI) used the 2007–2008 contaminated heparin incident to underscore that economically motivated adulteration from China had been a known but unresolved risk, and Mr. Coukell agreed that structural dependence on cheaper Chinese heparin had persisted despite new FDA authorities.

  Sen. Johnson asked about “precursor chemicals” and the scale of these inputs. Dr. Edwards said there were thousands, mostly made in China, with a smaller subset tied to the most critical medicines.

  Sen. Johnson pressed for a simple description of the chain from oil, minerals, plants, and biotech through key starting materials to APIs and final drugs. Dr. Edwards emphasized the need to map and prioritize the most critical materials.

  Sen. Johnson asked about raw materials and labeling, and Mr. Neely warned that even European APIs could still rely on Chinese precursors, defeating efforts to localize the supply chain.

• Ranking Member Gillibrand (D-NY) asked which economic incentives would most influence domestic investment and how current procurement practices created a race to the bottom on price. Mr. Neely stressed that volume and plant utilization were more important than price, and he suggested a sugar-style carve-out that guaranteed demand for domestic production; Mr. Coukell said Civica needed stable demand signals for very low-priced injectables that were otherwise not viable at U.S. costs. Mr. Cashman argued that small-business set-aside rules had unintentionally locked USA Antibiotics out of federal amoxicillin contracts despite its rescue by a larger U.S. investor, allowing subsidized foreign competitors to dominate.

  Sen. Gillibrand then raised cyber threats to drug manufacturers. Mr. Coukell and Dr. Edwards warned that plants cutting corners on quality likely also underinvest in cyber resilience.

  Sen. Gillibrand asked about ASPR and BARDA support. Dr. Edwards and Mr. Coukell praised their capital investments but urged more coordinated, well-funded, cross-agency authority and long-term funding, while Mr. Neely and called for targeted grants, loans, and tax incentives to fully utilize existing plants and build antibiotic capacity.

• Sen. Tuberville (R-AL) asked whether Oxford sold to VA and DOD and how the bid process worked. Mr. Neely said Oxford did sell through the Federal Supply Schedule but had repeatedly lost bids, including to a Chinese-American and India-linked firm that technically complied with current policy, and he argued that clearer rules were needed to level the playing field for fully domestic manufacturers.

  Sen. Tuberville asked what Oxford needed to quadruple production. Mr. Neely said the plant already existed and could scale from 180 million to over 600 million doses per month with about $18 million in additional equipment, but current volume was capped because distributors focused solely on lowest cost.

  Sen. Tuberville asked what market changes were needed to make U.S. injectable production viable. Mr. Coukell replied that drugs priced at 30–40 cents per vial could not be profitably made in the United States without purchasers explicitly paying more for quality and domestic sourcing.

• Chair Scott (R-FL) focused on double standards in regulation and the risks of foreign dependence. He asked how FDA inspections worked and what would happen if U.S. plants had the same birds, lizards, and other contamination recently found in an Indian facility. Mr. Neely and Mr. Cashman replied that their plants would be shut down regardless of shortages, whereas foreign firms often shifted production or warned of shortages to avoid consequences.

  Chair Scott pressed on the consequences of losing domestic capacity. Mr. Cashman and Dr. Edwards warned the U.S. would be fully dependent on China and India for amoxicillin and APIs, threatening seniors and warfighters.

  Chair Scott closed by emphasizing that broader Medicare and commercial changes, Section 232 national security tools, stronger testing of imports, and transparency on country of origin were needed to shift purchasing toward higher-quality, reliably supplied domestic generics.