By Isnaini Azizah 
The Commissioner’s critique focuses on the critical Phase 1 clinical trial stage, where the safety of a new drug is first tested in humans. Historically, the U.S. was the undisputed leader in this "first-in-human" research, but recent data suggests a tectonic shift. Makary pointed specifically to three systemic bottlenecks that have allowed international competitors, most notably China, to outpace American efforts. These friction points—hospital contracting, ethical reviews, and the Investigational New Drug (IND) application process—represent what Makary describes as "clunky processes that take too long and are leaving us noncompetitive."
The first of these bottlenecks, hospital contracting, is often an overlooked hurdle in the drug development lifecycle. Before a clinical trial can begin at a major academic medical center or hospital system, lawyers and administrators must navigate a dense thicket of liability agreements, intellectual property rights, and financial terms. These negotiations can frequently stretch from six months to over a year, even when the underlying science has already been vetted. In contrast, China’s centralized healthcare model and state-directed research initiatives allow for much faster site activation. Makary suggested that the FDA is looking into ways to standardize these agreements or partner directly with health systems to ensure that administrative red tape does not stand in the way of scientific progress.
The second bottleneck involves the ethical review and approval process, primarily handled by Institutional Review Boards (IRBs). While these boards are essential for protecting human subjects, Makary argues that the process has become overly fragmented and redundant. Often, a multi-center trial must receive separate approvals from every individual hospital’s IRB, leading to contradictory requirements and months of delay. Makary’s vision involves a more unified, streamlined ethical review process that maintains safety standards without the repetitive administrative burden that currently plagues U.S. researchers.
The third and perhaps most significant hurdle is the process for submitting and receiving approvals for Investigational New Drug (IND) applications. The IND is the formal gatekeeper that companies must pass before they can legally test a new product in humans. Makary highlighted that the sheer volume of paperwork and the lack of early-phase communication between the FDA and developers have created a backlog. To combat this, the FDA is exploring a "pre-IND" partnership model. By consulting with industry players, academic medical centers, and health systems before an application is even filed, the FDA aims to provide a roadmap for success rather than a series of unexpected roadblocks. "We’re looking at everything," Makary stated, emphasizing a shift from a reactive regulatory stance to a proactive partnership.
The urgency of these reforms is driven by a stark reality: China is no longer just a manufacturing hub for generic medications; it is becoming a global powerhouse in biotechnology innovation. For decades, the Chinese pharmaceutical industry was characterized by the production of "copycat" drugs. However, a massive influx of state investment, coupled with aggressive talent recruitment from Western universities and a series of regulatory overhauls by the National Medical Products Administration (NMPA), has transformed the landscape. According to data from GlobalData and Morgan Stanley, China now conducts more clinical trials annually than the United States. Even more concerning for U.S. policymakers is the projection that China is on pace to account for 35% of all FDA approvals by the year 2040. Currently, China already accounts for nearly a third of new global drug approvals, signaling that the "innovation gap" is closing faster than previously anticipated.
This geopolitical competition is not just about prestige; it is about national security and economic sovereignty. The biotech sector is increasingly viewed as a critical infrastructure, similar to semiconductors or artificial intelligence. If the U.S. becomes dependent on China for the next generation of oncology treatments, gene therapies, and vaccines, it risks losing control over its own public health outcomes and supply chain stability. Makary’s comments reflect a broader Trump administration priority to "partner with industry to help them deliver more cures and meaningful treatments for the American public." He framed this as a bipartisan imperative, noting that the goal of accelerating medical breakthroughs is one that transcends political lines.
Central to Makary’s philosophy is the "Everything OTC" (Over-The-Counter) mandate mentioned in his opening remarks. This provocative stance suggests a fundamental re-evaluation of how the FDA classifies medications. By moving more drugs to OTC status—provided they are safe and do not require constant clinical monitoring—the FDA could significantly reduce the cost of healthcare for consumers and free up physician resources for more complex cases. This deregulation strategy is intended to empower patients and foster a market-driven approach to health. It also aligns with the administration’s broader goal of reducing the size and scope of the "regulatory state," which Makary and his colleagues argue has become an impediment to American ingenuity.
However, the path to reform is fraught with challenges. Critics of rapid deregulation warn that cutting corners in the IND process or ethical reviews could lead to safety lapses, potentially undermining public trust in the FDA—a trust that has already been tested in recent years. Furthermore, streamlining hospital contracting requires navigating the complex, decentralized nature of the U.S. private healthcare system, which is far less susceptible to federal mandates than China’s state-controlled apparatus.
To bridge this gap, Makary is championing a "biotech renaissance" that leverages the unique strengths of the American ecosystem: its world-class research universities and its vibrant venture capital market. By reducing the "clunky" barriers to entry, the FDA hopes to encourage more domestic startups to keep their research on U.S. soil rather than seeking faster approval timelines in overseas markets. The "pre-IND" consultation process is a key part of this strategy, intended to provide "regulatory certainty" to investors who are often wary of the long and unpredictable timelines associated with FDA approval.
The 2024 data on Phase 1 trials was a wake-up call for the agency. Makary’s admission that "we walked into a mess" suggests that the current administration views the previous years as a period of stagnation where the U.S. rested on its laurels while China built a superior infrastructure for clinical research. The shift toward a 35% Chinese share of FDA approvals by 2040 is a trajectory that Makary is determined to intercept.
In the coming months, the medical community and the pharmaceutical industry will be watching closely to see how these high-level goals translate into specific policy changes. Will the FDA implement a unified IRB system? Can it successfully incentivize hospitals to adopt standardized clinical trial contracts? And most importantly, will the "Everything OTC" philosophy lead to a significant expansion of accessible medications for the average American?
Makary remains optimistic, asserting that the administration is committed to getting these reforms done. The vision he outlines is one of a more agile, industry-friendly FDA that views itself not as a barrier to be overcome, but as a catalyst for innovation. As the global race for biotech supremacy intensifies, the stakes could not be higher. For Marty Makary and the FDA, the goal is clear: to ensure that the next generation of medical miracles is "Made in America," developed in American labs, and tested in American hospitals, ensuring that the U.S. remains the world’s primary engine for medical discovery in the 21st century.