U.S. Policy Drift And The Shift In Clinical Trial Supply Leadership

By Dan Leonard, executive director, We Work For Health

Any driver knows the feeling of being passed on a highway.

Sometimes, you see the other car coming from a mile away; you might even change lanes to ease the overtake. Other times, a fellow commuter with a heavy foot emerges from seemingly nowhere, buzzing past audibly at an incredible speed.

China’s biopharmaceutical industry, souped up with state funding, a history of intellectual property appropriation, and an aggressive long-term strategy, just roared by the United States in a critical metric. A recent report from the GlobalData research firm confirmed that China, a country that has historically prioritized shortcuts over first-in-class drug development, suddenly leads the world in clinical trial volume.

Addressing the clinical trial deficit between the U.S. and China must be among the most actionable near-term priorities for policymakers and regulatory leaders.

China has built structural advantages into its clinical trial system by fully integrating trials with its hospital infrastructure. Large hospitals are required to maintain clinical research divisions; patient care and trial participation are routine components of the same care encounter. This integration accelerates enrollment, reduces friction in trial initiation, and embeds research capacity into the delivery system at scale. It also stabilizes investigational product demand earlier by linking recruitment directly to care delivery pathways.

China’s system enables significantly faster clinical trial execution, shortening the timeline from early discovery to an IND application by 50% to 70%, according to McKinsey.

In the U.S., the clinical trial infrastructure is considerably more fragmented. Contracts are negotiated independently, review boards convene separately, and recruitment networks are stitched together outside normal treatment. Integration is the exception, not the rule. Each of these steps contributes to a longer timeline for the approval of a new medicine.

IND timing differences directly shape clinical supply execution. Longer regulatory approval cycles in the United States delay manufacturing authorization and compress downstream packaging, labeling, and distribution planning windows. This creates structural pressure on supply organizations to either build inventory risk ahead of approval or compress execution timelines after authorization, increasing volatility in early trial supply delivery.

Longer approval cycles also push manufacturing and packaging decisions later into the life cycle, leaving clinical supply teams with tighter execution windows and more opportunities for mishaps to compound into further delays.

Fortunately, FDA Commissioner Marty Makary acknowledged the challenge ahead in a recent editorial, recognizing that China is currently initiating more clinical trials than the U.S. and identifying the IND pathway as a priority area for reform.

The agency announced an initiative to pilot-test real-time clinical trials. Under the new model, FDA regulators can monitor safety signals and clinical endpoints as they occur, streamed directly to the agency via a secure cloud. This represents a meaningful break from the traditional approach in which data is collected manually, compiled across disconnected systems, and submitted in batches for review. The broader goal is continuous trials that eliminate the lengthy pauses between development phases, often referred to as “dead time,” which currently accounts for nearly half the span between a Phase 1 trial and final submission.

The IND framework itself is equally overdue for an overhaul. It has not been comprehensively reviewed in decades, and meaningful efficiency gains are achievable by identifying and eliminating requirements that do not materially contribute to safety or efficacy evaluation. The FDA is now collaborating with trial sponsors to utilize AI and modern data science to significantly reduce the information bottlenecks that have long added unnecessary time – and cost – to U.S. drug development.

Shorter approval timelines allow supply planning to align more closely with confirmed trial activation. This improves synchronization between manufacturing campaigns, packaging operations, and site-level demand signals, reducing reliance on excess buffer stock and improving allocation efficiency across global studies.

Australia offers an instructive decentralized model worth examining. Rather than routing all applications through a central regulatory body, drug sponsors engage local Human Research Ethics Committees. That structure allows clinical studies to begin in a matter of months, not years. The lesson for the U.S. ends there, however. Australia's aggressive price controls on prescription drugs place a major burden on its domestic biotech sector – a cautionary reminder that streamlining clinical trials means little if the policy environment discourages the investment needed to run them in the first place.

Global Biopharmaceutical Competition Is Reshaping Clinical Trial Systems

America’s position as the global leader in biopharmaceutical innovation is no longer on cruise control.

The downstream implications of this shift are already becoming evident. China’s share of global biopharmaceutical research and development quadrupled between 2014 and 2024. Further, Morgan Stanley projects that, by 2040, 35% of all drugs approved by the FDA will originate in China as opposed to the 5% today.

China passed us on the clinical trial freeway because its leadership committed to systematically investing in and streamlining its biopharmaceutical infrastructure. Beyond funding, China also restructured its regulatory system to move drugs through the pipeline faster — and made a concerted effort to bring home world-class scientific talent to fuel its domestic research base.

As that happened in plain view, U.S. policymakers have pulled various levers to slam on the industry’s brakes: cutting funding for basic science research, creating uncertainty at the FDA, sending the wrong signals about intellectual property protections, and imposing price controls that suppress investment in R&D.

Even today, some policymakers are pushing the most favored nation (MFN) drug pricing model that would further compress returns on R&D investment.

There is still time to change course; however, history is clear about what happens to nations that let competitive advantages slip away through avoidable policy mistakes.

History Lesson

Europe supplied the world’s medicine cabinet in the 1980s, led by the likes of Germany, the U.K., Switzerland, and France. Gradually, that position faded because the continent’s leaders made one bad policy choice after another.

Price controls. Slowdowns on regulatory approval. Restrictions on patient access to specific medicines. The pursuit of cost containment, however well-intentioned, short-circuited the innovation engine that allowed Europe to thrive because they used government price controls and not competition in the marketplace. Those constraints also forced more conservative clinical supply positioning earlier in development cycles.

Meanwhile, across the Atlantic, the U.S. was building itself an express lane.

The Bayh-Dole Act of 1980 empowered universities to commercialize federally supported research, fundamentally transforming the relationship between academic science and commercial drug development. The result was a complete reversal of competitive positions. In the 1970s, Europe accounted for 55% of new medicines versus a 31% U.S. share. By 2001–2010, the U.S. share of new pharmaceutical products had risen to 57%, with Europe's leading nations dropping to 33%.

European patients are still paying the price. In France and Spain, patients now wait an average of 500 to 600 days to access newly developed medicines. A study of oncology products in the European Union found that some member states never saw the launch of certain cancer drugs at all.

Time To Catch Up

There are reasons to be optimistic about our future.

In addition to the FDA's proposed reforms, Congress has taken steps to address the competitive gap at a systemic level.

The National Security Commission on Emerging Biotechnology, created by Congress to deal with this very challenge, has issued a number of important recommendations, including the designation of a senior individual in each relevant cabinet department to coordinate biotechnology policy and a mandate for federal departments and agencies to make regulatory pathways more efficient for bringing new products to market. This also improves predictability in clinical supply planning cycles across development portfolios.

From a clinical supply standpoint, clearer and more standardized regulatory pathways improve predictability in manufacturing scheduling, packaging capacity planning, and contract manufacturing organization utilization. When manufacturers can plan around predictable timelines, they can build more reliable production schedules, reduce bottlenecks, and spend less time reacting to delays — and more time getting drugs to patients.

Maintaining America’s global leadership in the life sciences is arguably among the most important national challenges of our generation and is imperative for our health, our economy, and our national security. The U.S. has the scientific talent, academic infrastructure, and institutional knowledge to guide the next generation of drug innovation.

Policymakers must meet the moment.

We’ll see what is left in their tank.

About The Author:

Dan Leonard is the executive director of We Work For Health, where he draws on more than 20 years of association leadership to advance strategic planning, advocacy, policy and public affairs across the healthcare ecosystem. He previously served as president and CEO of the Association for Accessible Medicines and, prior to that, president and CEO of the National Pharmaceutical Council (NPC).