The re-election of Donald Trump in 2024 marks the start of a dramatic transformation in healthcare, biotech, and clinical trials. The administration’s priorities—deregulation, domestic production, and national security—are set against rising global tensions and America preparing for heightened global conflict – especially with China. These shifts will profoundly impact how drugs and treatments are developed, tested, and delivered, forcing stakeholders to navigate a landscape of urgency and uncertainty.
Healthcare Restructured: Efficiency at a Cost
Trump’s approach to healthcare mirrors a corporate restructuring strategy. By appointing Elon Musk and Vivek Ramaswamy to the Department of Government Efficiency 1, the government could run more like a corporation than a government agency. Regulatory agencies like the FDA could streamline drug approvals and potentially slash red tape for efficiency; During the Trump administration, the FDA increased the use of accelerated approval pathways, particularly for oncology drugs. Between 2017 and 2020, the FDA granted accelerated approval to 40 oncology indications, some involving one drug for multiple indications 2. This uptick reflects a broader trend of utilizing expedited programs to hasten patient access to critical therapies.
While accelerated pathways could facilitate innovation, history has shown that prioritizing speed over scrutiny often comes at a cost. The approval of Biogen’s Alzheimer’s drug Aduhelm under an accelerated pathway in 2021 exemplifies this risk 3. The decision sparked controversy over the drug’s efficacy and safety, eroding trust in regulatory oversight. As political pressure mounts to deliver rapid results, the FDA could become more of a rubber stamp for approvals, raising concerns about the long-term safety and efficacy of new treatments.
Efficiency is essential, but it cannot come at the expense of oversight. The administration’s challenge will be to balance the demand for speed with the need to maintain public trust in the scientific process. Without this balance, the healthcare system risks undermining the very innovation it seeks to foster.
Big Pharma: Thriving Amid National Priorities
Rising global tensions and civil unrest in the United States are driving the government to incentivize companies to shift production and manufacturing back to American soil, reducing reliance on outsourcing. For big pharma, the Trump administration’s “America First” policies present opportunities to bolster domestic manufacturing, though these opportunities come with new constraints and challenges to navigate.
Pfizer’s $450 million expansion of its Kalamazoo, Michigan, manufacturing facility exemplifies this trend 4. The investment strengthens Pfizer’s capacity to produce sterile injectable medicines and active pharmaceutical ingredients, which are critical for hospitals worldwide. The facility currently supplies over 150 products to 120 countries, and this expansion positions it to meet rising global demand while advancing sterile manufacturing technologies.
Such investments are facilitated by favorable tax policies, including proposed reductions in corporate tax rates for companies manufacturing domestically. President Trump has advocated for lowering the corporate tax rate to 15% for companies that produce in America, aiming to incentivize domestic manufacturing and reduce outsourcing 5. These federal incentives and state-level tax benefits make large-scale onshoring projects more financially viable.
This project also highlights the administration’s emphasis on domestic manufacturing as a strategy for securing jobs and protecting America’s critical healthcare infrastructure. The Kalamazoo expansion is estimated to create 450 new jobs in Michigan and represents over $1.1 billion in investments through 2024, blending economic growth with enhanced supply chain resilience in case of a global conflict. While these efforts strengthen domestic capabilities, they also come with higher operational costs that may challenge profitability in the short term, which would reflect on big pharma’s balance sheets.
Biotech Startups: Innovation Meets Funding Challenges
For biotech startups, deregulation presents a double-edged sword. While relaxed oversight of emerging technologies like AI and digital health fosters innovation, shifting public funding priorities could create challenges. Federal agencies like the NIH, which has long been a critical source of early-stage funding, are unlikely to face overall budget cuts; A report from the Congressional Research Service highlights the NIH’s outsized role in shaping biomedical innovation, with over $43 billion in annual funding allocated to projects across the spectrum of basic, applied, and clinical research 6. However, the administration may redirect resources toward national security priorities supporting an “America First” directive, such as bioterrorism countermeasures and advanced therapeutics, potentially deprioritizing areas like basic research, rare diseases, or global health. This realignment could leave startups working outside these priorities struggling to secure essential grants.
Biotechs will need to adapt swiftly to these shifting priorities. Companies focused on niche or exploratory fields may be disadvantaged, while those aligned with government-backed objectives could benefit from increased funding opportunities and partnerships. This environment favors projects with immediate applicability to national security or public health emergencies, potentially stifling creativity in less prioritized areas. While redirecting NIH resources might spur innovation in high-urgency fields, it also risks narrowing the diversity of research supported, which could have long-term consequences for the broader biotech ecosystem.
Global Collaboration Under Threat
Geopolitical tensions and the U.S. administration’s “friendshoring” strategy are reshaping the clinical trials landscape. By prioritizing alliances with politically aligned nations, the U.S. aims to reduce reliance on countries like China, which has become a leader in oncology research 7. This shift could disrupt collaborative efforts, potentially slowing advancements in critical medical fields.
For example, the U.S. has strengthened partnerships with Vietnam and India to diversify supply chains away from China 8. Additionally, the creation of an FDA bureau in the Middle East has been proposed to accelerate the development of new healthcare and biomedical technologies, exemplifying friendshoring in the medical field 9.
Emerging markets such as Brazil and India may fill this void, offering diverse patient populations and improving trial infrastructures. Brazil’s recent regulatory reforms, including streamlined clinical trial approvals under Law No. 14.874, have created a more predictable and efficient environment for international sponsors 10. Meanwhile, India’s large, diverse patient population and cost-effective infrastructure make it a hub for clinical trials, as illustrated by Sanofi’s $400 million investment in its Hyderabad Global Capacity Centre 11. However, the fragmentation of global research poses risks.
While friendshoring fosters resilient alliances, the fragmentation of global research networks risks slowing innovation in addressing health challenges. Global conflicts and tariffs could destabilize alliances, potentially turning friendshoring countries into adversaries and undermining investments. Clinical trials, which rely on international collaboration, risk losing access to diverse expertise and resources critical for tackling complex health issues. To adapt, stakeholders must carefully evaluate geopolitical risks and opportunities, balancing national security priorities with the need for robust global scientific partnerships.
The Shadow of War: National Security Over Global Health
The alignment of healthcare and biotech with national security is profoundly reshaping the industry. As the U.S. gears up for potential conflict, resources are increasingly funneled into defense-related priorities like pandemics 12, bioterrorism countermeasures 13, battlefield therapeutics 14, and supply chain resilience for critical drugs. While these shifts accelerate breakthroughs in high-priority areas, they risk sidelining fields such as rare diseases, preventative care, and global health initiatives.
War also exacerbates supply chain vulnerabilities, potentially disrupting access to key pharmaceuticals. As mentioned earlier, efforts to reshore production may strengthen resilience but could drive up costs, limiting global affordability. Under pressure to fast-track defense-critical innovations, regulatory agencies may face challenges in maintaining rigorous safety and efficacy standards. Beyond funding and logistics, prolonged conflict shifts public and policymaker attention to crisis-driven interventions, often at the expense of long-term health infrastructure and equity.
What Stakeholders Can Do to Adapt
Adapting to this new landscape requires bold action and strategic foresight. Big pharma must double down on reshoring production and align R&D with national priorities without losing sight of global markets critical for sustained growth. Biotech startups should seek private funding and pivot toward defense-related innovations to remain viable. Sponsors and CROs must embrace decentralized trials while ensuring equity and diversity remain central to their designs. Global players should diversify trial locations, leveraging emerging markets in allied regions to maintain efficiency and inclusivity.
Conclusion
The Trump administration’s policies and rising global tensions are reshaping the clinical trials and biotech industries. Deregulation, domestic production, and national security priorities present opportunities for innovation and growth but also risks to global collaboration and equity. As America prepares for a new era of conflict, the industry must navigate a fine line between urgency and integrity. Success will depend on adapting to these shifts while maintaining the core principles of scientific and ethical rigor.
References
- https://www.cnn.com/2024/11/12/politics/elon-musk-vivek-ramaswamy-department-of-government-efficiency-trump/index.html ↩︎
- https://cancerhistoryproject.com/article/accelerated-approval-and-the-fda/ ↩︎
- https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html ↩︎
- https://www.pfizer.com/news/announcements/michigan-ready-cures ↩︎
- https://www.marketwatch.com/story/trump-calls-for-slashing-corporate-tax-rate-for-domestic-producers-only-1ff7e379? ↩︎
- https://www.gao.gov/assets/gao-23-105656.pdf? ↩︎
- https://www.ft.com/content/3d861acb-8e7d-4157-b845-81124254da8a? ↩︎
- https://www.sriramsias.com/upsc-daily-current-affairs/onshoring-friendshoring-and-nearshoringglobal-supply-chain-adjustments-simplifier/ ↩︎
- https://www.usieducation.org/medical-friendshoring ↩︎
- https://www.clinicalleader.com/doc/new-law-expected-to-boost-clinical-research-in-brazil-0001 ↩︎
- https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-invest-437-mln-india-global-centre-double-its-workforce-2024-07-17/ ↩︎
- https://www.wired.com/story/moderna-mrna-vaccine-bird-flu-h5n1/ ↩︎
- https://www.whitehouse.gov/briefing-room/statements-releases/2022/10/18/fact-sheet-biden-harris-administration-releases-strategy-to-strengthen-health-security-and-prepare-for-biothreats/ ↩︎
- https://cdmrp.health.mil/pubs/press/2024/24crrppreann ↩︎
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
