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# Hearing Highlights Concerns Over Biomedical Innovation Growing in China
- URL: https://www.fdaweb.com/hearing-highlights-concerns-over-biomedical-innovation-growing-in-china/
- Published: 2026-07-15T12:00:00.000Z
- Updated: 2026-09-14T13:42:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161458

Witnesses appearing before a House Energy and Commerce Health Subcommittee hearing are urging lawmakers to modernize the nation's clinical trial system, strengthen FDA’s scientific capacity, and increase federal investment in biomedical research, warning that China is rapidly eroding the leadership the U.S. has held in early-stage drug development.

The [7/15 hearing](https://energycommerce.house.gov/events/maintaining-america-s-leadership-in-biomedical-innovation-fda-s-role-in-advancing-u-s-drug-development?ref=fdaweb.com), titled “Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Competitiveness,” brought together executives from industry, academia, patient advocacy groups, and global health experts, broadly agreeing that FDA reforms underway — including the agency's recently announced Operation Trialblazer initiative — are a positive step but will require congressional support to achieve meaningful change. The initiative aims to modernize clinical trial regulations, improve transparency, and streamline early-stage research ([see earlier story](https://www.fdaweb.com/hhs-unveils-initiative-to-accelerate-u-s-clinical-trials/)).

IQVIA R&D president **Cindy Burst** said data collected by the company show China surpassed the U.S. in Phase 1 clinical trial activity several years ago. She said China accounted for 35% of global Phase 1 innovative industry trial starts at the end of 2025, compared with 27% for the U.S.

Burst cautioned, however, that the figures require context. The United States remains the most sought-after market for new medicines," she told lawmakers, noting that most Chinese Phase 1 studies are conducted by Chinese companies for products intended for China's domestic market.

She argued that FDA review timelines are not the primary reason sponsors launch first-in-human studies overseas. Instead, smaller biotechnology companies frequently choose countries such as Australia because preparing extensive IND applications required by FDA takes significant time and resources.

Burst recommended that Congress support a "fit-for-first-in-human" regulatory framework that tailors initial data requirements according to a product's risk profile while allowing FDA reviewers to provide more iterative scientific advice throughout development.

Reagan-Udall Foundation CEO and former FDA senior official **Susan Winkler** said stakeholder meetings organized by the foundation produced recommendations that closely mirror FDA's Operation Trialblazer initiative. Among the most frequently cited reforms, she said, were clearer, phase-appropriate IND requirements and greater opportunities for sponsors to interact with FDA scientists early in development.

Winkler also urged lawmakers to examine the nation's capacity to conduct first-in-human trials, suggesting Congress consider establishing a network of specialized Phase I clinical research centers. She also highlighted inefficiencies that occur after FDA clears a study to begin, including lengthy contract negotiations between sponsors and research sites, which she said unnecessarily delay patient enrollment.

Harvard Medical School’s **Thomas Wang** said recent research shows an increasing share of early-stage oncology studies supporting FDA approvals now includes clinical sites in China. Although international collaboration benefits patients, Wang said Congress should ensure overseas research meets the same standards for ethics, safety and data integrity expected in the U.S.

Among his recommendations was congressional support for FDA's initiative to publicly release Complete Response Letters explaining why drug applications are rejected. Wang said expanded transparency could help sponsors avoid repeating development mistakes while improving efficiency throughout the drug development process. He also recommended increasing FDA inspections of foreign clinical trial sites and exploring coordinated reviews of IND applications with trusted international regulatory agencies.

Bloomberg Chair in Global Health at the Council on Foreign Relations **Tom Bollyky** testified that China's growing dominance in early-stage clinical development is both an economic and national security concern. He said China now offers first-in-human clinical trial pathways that are three to five times faster and substantially less expensive than those available in the U.S., supported by government subsidies, integrated contract research organizations and large patient populations. Among his recommendations were the creation of expedited regulatory pathways for lower-risk products, greater investment in U.S. Phase 1 clinical research infrastructure, expanded FDA inspection resources and renewed federal investment in both FDA and the National Institutes of Health.