Maintaining America’s Leadership in Biomedical Innovation
Committee
Committee on Energy and Commerce
Hearing Title
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development
Mr. Bollyky’s remarks to the U.S. House of Representatives Committee on Energy and Commerce featured three key points:
I. How U.S. Dependence on China Expanded into Drug Development
Over the last decade, China surged up the innovation ladder using the same playbook it deployed on generic medicines: exploiting permissive U.S. regulations, offering weaker environmental standards, discounted inputs, and economies of scale. As recently as 2008, nearly all U.S.-administered amoxicillin was domestically manufactured; today 92 percent of its key ingredients come from China.
The same dynamic has now reached clinical trials. A 2008 FDA regulatory change permitted foreign clinical data to support U.S. drug applications, and China responded with sweeping reforms — joining international harmonization standards, slashing IND approval times from years to weeks, and building a dense contract research ecosystem. Early-stage trials in China are now three to five times faster than in the U.S. and cost one-third to one-half as much. China’s share of global clinical trial starts rose from one percent in 2009 to roughly 30 percent in 2024.
II. The Risks to U.S. Biosecurity, Public Health, and Patients
There are three categories of risk from ceding U.S. leadership in clinical research and biopharmaceutical innovation to China.
First, China could weaponize its control of critical drug supply chains for geopolitical leverage — as it has already demonstrated with rare earths, critical minerals, and agricultural products. Chinese firms hold 32 of 55 monoclonal antibody programs globally, a $380 billion product class deployed in cancer immunotherapy, autoimmune treatment, and antiviral therapies against biological and pandemic threats. The National Security Commission on Emerging Biotechnology projects China will represent roughly one-third of U.S. FDA approvals by 2040.
Second, the competitive erosion of U.S. pharmaceutical capacity undermines economic security and the ability to produce countermeasures in a crisis. Seventy-nine percent of pharmaceutical companies use Chinese contract manufacturers, reflecting accumulated know-how that cannot be quickly unwound.
Third, FDA cannot effectively oversee research conducted in China. Of 2,732 eligible GCP inspections conducted between 2016 and 2023, only 20 occurred in China — while 93 percent occurred in the United States. Since many first-in-human trials in China proceed without a U.S. IND, FDA only learns of them when sponsors later submit the data, at which point any harms to human subjects are already irreversible.
III. China’s Strategy and Its Advantages
China’s rise in biopharmaceutical innovation is not a market outcome — it is the product of decades of coordinated state investment under Made-in-China 2025, which designated biopharmaceuticals as a strategic sector. Beijing provided tax holidays, low-interest loans, land discounts, dedicated biotech hubs, and a scientific-ethics system with Chinese characteristics that reportedly permitted animal and gene-editing experiments off-limits in the West. The result is a system that is genuinely faster and cheaper than the U.S. IND process, creating a structural competitive advantage that small U.S. biotech firms cannot easily overcome.
IV. Steps Congress and FDA Should Take
There are five steps Washington can take to restore U.S. leadership in biomedical innovation.
- First, Congress and FDA should streamline early-stage U.S. clinical trial pathways — drawing on models from Australia’s expedited notification pathway and Norway’s NorTrials public-private infrastructure — to make the U.S. more competitive without sacrificing patient safety. The recently released Operation Trialblazer has elements of these approaches that deserve further refining and implementing.
- Second, FDA should reduce regulatory friction around switching from Chinese contract manufacturers to advanced domestic alternatives, including by providing model comparability protocols for assessing new technologies and expediting post-approval manufacturing change reviews.
- Third, FDA should proactively identify and authorize temporary importation of essential medicines from well-regulated allied markets in sectors where China holds concentrated market dominance, rather than treating it as a last resort.
- Fourth, Congress must restore and sustain staffing at FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research — both currently down 16–18 percent from the start of FY2025 — and consider a user fee to fund enhanced GCP inspections of foreign clinical trial sites.
- Fifth, Congress should continue investing in the broader enabling environment for U.S. biomedical innovation, including FDA, NIH, and ARPA-H, recognizing that every licensing deal signed with a Chinese biotech firm transfers commercial rights and development expertise that downstream manufacturing policy alone cannot recover.