Reasons to Pay Attention to Makary's Comments Around Losing Drug Development Ground to China

The United States risks ceding leadership in early-stage drug development to China because of avoidable regulatory and operational delays in initiating clinical trials, according to recent comments by FDA Commissioner Marty Makary.¹ In a televised interview, Makary identified hospital contracting, institutional review board (IRB) processes, and Investigational New Drug (IND) application review timelines as key bottlenecks that may be slowing first-in-human and early-phase studies in the US.

How Do US and China Early Development Pipelines Compare?

Currently, China is ahead of the US in clinical trials, accounting for around one-third of emerging, global drug approvals.¹ Makary is citing structural constraints that could influence sponsors to conduct phase I and early phase II trials in China over the US. Early development geography can shape subsequent regulatory strategy, patient access, and the global evidence base.

In the interview, Makary called for reforms to streamline trial initiation.¹ He cited three specific areas of concern: protracted hospital contracting negotiations, duplicative or slow-moving ethical review processes, and the time required for IND submission and clearance.

Under current US law, sponsors must submit an IND application to the FDA before initiating clinical trials in humans.² The agency has 30 days to review the application and may impose a clinical hold if safety or protocol concerns arise. While the statutory timeline is fixed, pre-IND preparation, sponsor–FDA interactions, and post-submission queries can extend development timelines. Additionally, multicenter trials often require negotiation of site-specific clinical trial agreements and budget terms, as well as IRB approval, processes that may vary widely across institutions.

China, by contrast, has implemented regulatory reforms in recent years aimed at accelerating drug development.³ In 2017, China’s National Medical Products Administration joined the International Council for Harmonization, committing to align technical requirements with global standards. Subsequent reforms have included implied approval mechanisms for INDs if no objection is raised within a specified period and prioritization pathways for innovative therapies.

Although direct, head-to-head comparisons of median IND review times between the US and China are limited in the peer-reviewed literature, several analyses have documented a substantial increase in China-originated first-in-human trials and oncology innovation programs over the past decade.⁴

These comparisons along with Makary’s comments suggest that future reforms for US drug development will induce additional pressure on producers to shorten tech‑transfer timelines as well as implement more modular or single-use capacity.⁵ US partners will be expected to match the increased speed of China developers while still maintaining the high standards of compliance and quality, as standards are unlikely to be adjusted.

What Do Makary’s Comments Imply About the Future of Clinical Development?

FDA has previously emphasized its commitment to expediting innovative therapies through mechanisms such as Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations.² However, these programs primarily affect later-stage development and review. Makary’s comments focus on the pre–proof-of-concept period, where operational inefficiencies rather than formal regulatory timelines may predominate.¹

Adjustments will need to be made to portfolio and trial-location strategy in order for assets to reach first‑in‑human and proof‑of‑concept in competition with China.¹ US and EU developers are under pressure to innovate news ways to streamline early‑phase IND processes and adopt more adaptive or decentralized trial designs to match China’s speed of output.

The US continues to lead globally in total biopharmaceutical R&D spending and in the number of new molecular entities approved annually.⁶ Additionally, the FDA’s 30-day IND review window is relatively short compared with some international counterparts.²

The more salient issue may be system-level fragmentation rather than statutory review times.⁴ A 2020 analysis of global clinical trial trends demonstrated significant expansion of early-phase oncology trials in China, accompanied by regulatory reforms and domestic investment. Still, the quality, reproducibility, and global generalizability of early-phase data require careful evaluation regardless of geography.

What Are the Next Steps for US and EU Manufacturers?

Makary’s statements should be interpreted as policy signaling rather than evidence of imminent regulatory change, as they were presented with no new trial data or FDA guidance.¹ Comparative metrics on median trial startup times, IND clearance intervals, and contract negotiation durations would be necessary to quantify the scope of the issue.

Future reforms could include expanded use of centralized IRBs, harmonized contract templates across federally funded institutions, and enhanced pre-IND consultation programs.³ Policymakers may also look to international models for implied approval or parallel review mechanisms. Any regulatory adjustments that reduce early-phase startup timelines could influence site selection strategies, patient recruitment, and competitive positioning in global drug development.

Along with likely future reforms to accelerate early‑stage approvals, US authorities be more vigilant with the sharing of data and re-investment in regional development.⁵ The sharing of sensitive biological and clinical data with Chinese developers and other countries of concern are likely to be more restrictive. Development teams will have to balance the leveraging of speed and capacity of China’s developers with US scrutiny on clinical data provenance, trial diversity, and biosecurity.

References

1. CNBC. FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals. February 18, 2026. https://www.cnbc.com/amp/2026/02/18/fda-chief-warns-us-is-losing-ground-to-china-in-early-drug-trials.html
2. US Food and Drug Administration. Investigational New Drug (IND) Application. Updated 2023. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
3. National Medical Products Administration. China joins ICH and advances regulatory reform. Published 2017. https://www.nmpa.gov.cn
4. Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Intern Med. 2016;176(12):1826-1833. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2565715
5. PharmCube. US Regulatory Tightening: Impact or Benefit on China's Pharma Industry?. LinkedIn. 2025, Sep 15. Accessed February 20, 2026.https://www.linkedin.com/pulse/us-regulatory-tightening-impact-benefit-chinas-pharma-industry-pmvac/
6. IQVIA Institute for Human Data Science. Global Trends in R&D 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2023