The Hidden Risk in U.S. Medicines

Senate Aging Committee talks China/India dependencies, shortage math, and real market levers.

September 18, 2025

⚡️ NIMITZ HEALTH NEWS FLASH ⚡️ 

“Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to Aging Americans”

Senate Aging Committee

WITNESS & TESTIMONY

HEARING HIGHLIGHTS

Inspection Parity and Data Integrity

Foreign inspections that were pre-announced allowed concealment and data manipulation, while unannounced inspections surfaced the true state of quality; aligning inspection strategy globally was identified as critical to restore reliable safety signals. Stronger enforcement—up to excluding law-breaking plants from the market—was described as necessary to end the “cat-and-mouse” pattern of shifting production within corporate networks after findings.

API/KSM Dependence & Shortage Risk

Key starting materials and intermediates for critical generics were concentrated in China and India, creating a vulnerability where a geopolitical cutoff could disrupt or shut down supply of antibiotics, cardiac drugs, insulin, and more within months. Mapping showed that roughly half of finished generics came from India and that 70–80% of India’s starting materials originated in China, implying widespread U.S. exposure if those inputs were curtailed. USP’s analysis further tied fragility to four drivers—downward price pressure, manufacturing complexity, geographic concentration, and quality disruptions—that collectively discouraged reinvestment and redundancy.

Transparency & Market Incentives

A five-star, risk-based quality rating and country-of-origin disclosure were proposed to make drug quality and location visible throughout the chain, allowing purchasers and consumers to steer demand toward higher-quality manufacturers. Experimental evidence indicated that transparency about both location and quality shifted preferences in favor of demonstrably high-quality products—even when made in China or India—suggesting a path to reward quality across geographies while nudging on-/near-shoring.

MEMBER OPENING STATEMENTS

  • Chair Scott (R-FL) framed the hearing as a drug-safety and supply-chain risk problem for seniors, noting that 91% of prescriptions filled were generics and that the U.S. depended heavily on medicines and APIs from China and India. He asserted that many foreign-made drugs were lower quality and highlighted that 83% of top generics lacked a U.S. API source. He warned that single-supplier dependence had already forced emergency steps during shortages and said the committee would soon hold a solutions hearing.

  • Ranking Member Gillibrand (D-NY) emphasized the dual challenge of shortages and quality, citing New Yorkers’ difficulty accessing chemotherapy agents like cisplatin and carboplatin. She underscored the strain on FDA foreign inspectors and the risk that closing unsafe facilities could cascade into domestic shortages. She called for bipartisan work to strengthen access to high-quality generics while supporting effective inspections and enforcement.

WITNESS OPENING STATEMENTS

  • Mr. Baker stressed that generic drug safety must be unquestioned and described shortcuts and fraud uncovered in foreign facilities. He urged harsher penalties, country-of-origin labeling, independent third-party testing for products from higher-risk markets, and more unannounced foreign inspections. He concluded that better-resourced, unannounced inspections were essential to reveal true quality conditions.

  • Dr. Ball argued the generic market’s design and opacity created incentives to compete on cost at the expense of quality. He referenced research finding higher adverse-event rates for India-made generics compared with U.S.-made equivalents. He advocated drug quality and location transparency and global parity in FDA inspection practices, citing data showing pre-announced inspections hindered true assessment.

  • Mr. Daniels described supply-chain mapping work that revealed deep vulnerabilities extending back to raw materials and key starting materials. He urged modern transparency and monitoring to stress-test chains before they fail, warning that everyday prescriptions could trace to compromised sources. He pressed for improved visibility to protect patients, service members, and families.

  • Dr. Piervincenzi explained USP’s role and said over 90% of U.S. medicines were generics whose globalized supply chains had grown longer, more fragmented, and less transparent. He identified four drivers of vulnerability—downward price pressure, manufacturing complexity, geographic concentration, and quality disruptions—that together discouraged reinvestment in quality systems. He urged improved visibility (e.g., USP’s Medicine Supply Map analyzing 94% of U.S. prescriptions) and policies that reward resilience while preserving savings for patients and seniors.

QUESTION AND ANSWER SUMMARY

  • Sen. Johnson (R-WI) pressed for the single most practical first step to reduce dependence on China/India and improve drug quality. He floated country-of-origin labeling as an easy, consumer-facing start. Mr. Baker recommended enforcing existing laws despite shortage tradeoffs. Dr. Ball urged making quality and location transparent so markets could reward higher-quality manufacturers; Mr. Daniels advocated trade remedies against subsidized Chinese key starting materials and accelerating U.S. advanced manufacturing. Dr. Piervincenzi proposed a market-based “resiliency benchmark” that purchasers would pay a small premium to reward.

    Sen. Johnson also called for whistleblowers and said public awareness would be essential to move legislation. He closed by urging the panel to help identify a first drug category to “reshore and win,” reiterating that information transparency was foundational.

  • Sen. Kim (D-NJ) asked how a resiliency benchmark would operate in real purchasing and whether inspection parity and transparency could shift incentives without spiking prices. Dr. Piervincenzi described pay-for-resilience constructs that large buyers could adopt. Witnesses agreed unannounced foreign inspections were far more effective at surfacing patient-risk issues.

    Sen. Kim underscored the competitiveness angle for New Jersey’s biopharma base and the need to build domestic and allied capacity.

  • Chair Scott (R-FL) probed confidence in foreign-sourced generics and asked what adverse events were overrepresented. Mr. Baker said he lacked confidence in most products from China and India outside specific sites he had inspected. Dr. Ball cited signals such as cardiac arrest, GI hemorrhage, delirium, cellulitis, and acidosis, and he tied under-reporting to pre-announced inspections.

    Chair Scott urged more unannounced FDA presence to deter concealment.

  • Sen. McCormick (R-PA) focused on whether the U.S. could close cost gaps by siting facilities in competitive regions and leveraging advanced manufacturing. He argued that targeted domestic siting and streamlined permitting could restore capacity and reduce strategic exposure, framing the issue as both a competitiveness and national-security imperative.

  • Sen. Alsobrooks (D-MD) highlighted near-term patient impacts, asking about vaccine supply and complex hospital generics central to oncology and pediatrics. Dr. Piervincenzi noted vaccines were largely made in the U.S./EU/Canada with stronger oversight, while complex oncology generics on shortage lists were less substitutable and more disruptive.

    Sen. Alsobrooks pressed for senior-friendly transparency beyond origin labeling so purchasers and patients could interpret quality and resilience signals.