The FDA has taken important steps through Operation TrialBlazer and stronger scrutiny of foreign clinical data, but more must be done to make the United States more competitive in attracting clinical trials as China’s capabilities rise.
As clinical research increasingly shifts to China, not only does the U.S. stand to lose its lead in biotech, but patients will have fewer options for experimental treatments. To reverse this shift and keep clinical research for innovative medicines in America, the FDA needs to step it up.
This summer, the regulator acknowledged the problem and launched efforts to accelerate first-in-human trials as part of the Department of Health and Human Services’ broader Operation TrialBlazer Initiative. But there is much more the FDA can do to incentivize drug development on U.S. soil.
As a physician-scientist who has led clinical trials and moved programs through development, I have seen how added procedural layers can stretch timelines for patients who measure progress in months. Rare disease and cancer programs already face small patient pools, limited natural history data and difficult ethical questions around trial design. Extra delays do more than just slow a filing. They push the first patients into studies overseas, where U.S. clinicians cannot easily enroll and where the protocol is often not under FDA oversight.
Patients in these situations care first about getting into a trial while the product is still experimental. When Phase 1 and early proof-of-concept work leave the U.S. for China or Australia, American patients lose the slot and the U.S. loses the first approval if the therapies prove successful. Streamlining the U.S. process for first-in-human studies would serve both access and participation.
U.S. biopharma is already dependent on China and that dependence cannot be unwound on a crisis timetable.
The current period of leadership transition at the FDA creates an opening for these adjustments. Congress has already shown interest in the larger question of competitiveness, not only in walling off Chinese suppliers. The National Security Commission on Emerging Biotechnology told lawmakers in April 2025 that the United States has a short window to “make America innovate faster, and slow China down.”
By mid-2026, more than 30 of its recommendations had drawn bipartisan action, including the National Biotechnology Initiative Act, which would create a White House coordination office and simpler pathways to market, and the Senate-passed FDA Modernization Act 3.0, which would lock non-clinical testing reforms into regulation.
House appropriators, in the same FY2027 FDA report that floated a ban on China-generated data to support an investigational new drug (IND) application, also directed the agency to slim IND requirements and study an Australia-style notification pilot so early trials would not keep leaving the country. Separately, FDA’s proposed PDUFA VIII package would cut the new-drug application fee by half—on the order of $2.3 million at current rates—for products that include a U.S.-anchored Phase 1 trial started after October 1, 2027.
TrialBlazer made the same case from inside the executive branch: cut six to 12 months off the timeline to launching first-in-human studies so American patients and firms, not just Chinese sites, capture early development.
The agency can answer that call with focused reforms that tackle documented problems such as inspection gaps, opaque foreign trial data and single-source manufacturing. But we must steer clear of broader restrictions that carry their own costs. U.S. biopharma is already dependent on China—and not just for clinical trials—and that dependence cannot be unwound on a crisis timetable.
Congress recognized this reality by building a multiyear wind-down into the BIOSECURE Act. Nearly 80% of U.S. biopharma companies now contract with China-based or China-owned manufacturers, and WuXi Biologics is involved in nearly half of U.S. clients’ development programs. A sudden cutoff of Chinese supply could therefore leave patients exposed for years.
That is the patient cost of a sweeping bar. The molecule is not kept out of American pharmacies; it is rerouted, and U.S. patients wait. The business cost sits on top of that delay.
Moreover, because innovative drugs will inevitably reach the U.S. market, the world’s largest, there’s a massive economic loss that comes along with sweeping bans on Chinese collaboration. Among innovative-drug programs, GlobalData puts China’s share at about 30% in 2025, up from 4% in 2015. Cross-border licensing involving Chinese assets ran to roughly $136 billion in potential value in 2025. AstraZeneca has pledged up to $15 billion in China through 2030.
If the U.S. government makes those assets off limits, we’re giving Europe a leg up. The product still reaches U.S. patients; the value simply lands in Cambridge, U.K., instead of Cambridge, Massachusetts. That is a competitiveness loss masquerading as a security win.
The right way to bring clinical trials home
China now runs more clinical trials than the United States by several standard counts, and the shift happened quickly. China had under 8% of global registered trials in 2010 but had overtaken the U.S. in annual registrations by 2020.
The reason for this is clear—conducting clinical trials in China is quicker and more cost effective. Early-stage work is where the speed gap is widest. PhRMA and GlobalData put Phase 1 studies in China at roughly 50% faster and 30 to 40% cheaper than in the United States—on the order of seven months saved on a typical first-in-human study.
U.S. sponsors are increasingly treating China’s speed as a tradeoff, using its capacity while limiting what crosses the border. The DOJ’s April 2025 bulk-data rule restricts transfers of Americans’ genomic and other sensitive data to China, while the FDA in June 2025 stopped clearing trials that send U.S. patients’ living cells to China for genetic engineering. Companies are also rewriting contracts to ensure Chinese CROs and CDMOs do not control the only copies of cell banks, processes, or trial databases. The goal is straightforward: capture China’s speed without surrendering U.S. genomes, trade secrets, or manufacturing know-how.
Among changes I’d like to see at the FDA is a continued reduction of the burden of toxicology and manufacturing testing to enter human trials. Sponsors currently face heavy documentation before the first U.S. patient is dosed. These steps add time and cost that often push initial studies overseas.
A notification-based model for selected first-in-human studies, along the lines Australia already uses, would let programs begin sooner while leaving full safety review in place for later phases. That change would align with what the agency has recently said: that it will scrutinize foreign Phase 1 and early-feasibility data it cannot inspect. If those foreign starts get harder to use in a U.S. filing, sponsors need a lawful, faster door at home. Otherwise, the same work simply moves to Europe.
Later-stage work should carry similar incentives. Sponsors that conduct their main Phase 2 and Phase 3 studies in the U.S. and plan domestic manufacturing for trials and commercial supply deserve priority in the review queue. That work creates American jobs in clinical operations, data, regulatory affairs, and manufacturing. It also produces evidence in U.S. patients and builds operational experience with cell and gene therapies. Steering review resources toward these programs rewards the domestic investment the country needs.
Intellectual property protection requires a matching tool at the approval desk. Federal prosecutors have already shown what “misappropriated U.S. intellectual property” looks like in this industry. In one case, GSK scientists took internal anticancer research—including work on a HER3 antibody—to a Nanjing company that tried to sell the package as its own. In another, the International Trade Commission (ITC) found that trade secrets underlying a metabolic candidate from Viking Therapeutics and China-based Ascletis Pharma had been taken and that the respondents planned a U.S. filing.
Courts and the ITC can punish that conduct, but the FDA still lacks a clean way to refuse or withdraw an application when the product itself rests on that theft. Giving the agency straightforward authority to block or pull approval in those documented cases would target misuse without policing ordinary cross-border licensing or legitimate collaboration.
America retains strong advantages in basic research, risk capital and the ability to complete the full path from discovery to approval. It can keep that position by reducing the delays that send clinical work offshore and by creating clearer advantages for companies that choose to test and manufacture domestically.
Patients gain when new treatments reach them on shorter timelines and when more trials are available to give them access to experimental medicines. The broader economy gains when high-value development work stays inside the country. The innovation system gains when sponsors see sustained reasons to build and test in the United States rather than defaulting to faster options abroad.
Patients are waiting. The science continues to advance. Practical changes to how the FDA manages development can help both keep moving forward.
