How is Pharma Moving Forward?
The return of the Trump administration has the potential to significantly impact the U.S. pharmaceutical industry. Pharma leaders should brace for change.
- Regulatory shifts: The Supreme Court's move away from Chevron deference may lead to inconsistent FDA regulation interpretations across states, complicating areas like off-label marketing and drug approvals.
- Rare diseases and advanced therapies: Continued focus may incentivize R&D but increase scrutiny on orphan drug designations and pricing.
- Domestic manufacturing: "America First" policies could reshape supply chains and production costs.
- International operations: Temporary pause on Foreign Corrupt Practices Act enforcement may affect compliance strategies.
- Research priorities: Increased focus on biosecurity and preventive healthcare could influence product development and marketing strategies.
These challenges are likely to impact core industry aspects—from R&D to the supply chain—and may even significantly reshape the landscape of the U.S. pharmaceutical industry. This blog series covers the five key areas of impact, addressing ways that policy shifts are creating unprecedented challenges while simultaneously opening doors to strategic opportunities for companies willing to adapt.
Part One of the “Pharma Forward” series examined the shifting pharmaceutical landscape—unpacking the potential impact of regulatory changes like pausing FCPA enforcement and overturning Chevron deference. This second installment dives into where the rubber meets the road: how "America First" policies are already transforming pharmaceutical operations.
Manufacturing decisions that once seemed straightforward now carry strategic weight. Compliance approaches previously on autopilot require immediate recalibration. Emerging healthcare priorities are creating entirely new market opportunities for companies nimble enough to seize them. The stakes couldn't be higher.
Companies clinging to pre-2025 operating models face existential threats, while those embracing strategic adaptation are positioning themselves for market leadership. This article cuts through the uncertainty to deliver practical strategies that forward-thinking pharmaceutical executives can implement today to transform potential disruption into sustainable competitive advantage.
Domestic manufacturing and supply chain reshoring
Trump's "America First" policy stance could bring renewed focus on domestic pharmaceutical and medical device manufacturing. With the push to manufacture in country, any transitioning manufacturing operations, will result in increased costs and operational challenges. The Trump Administration has already threatened the biggest pharmaceutical companies that they face tariffs if they do not re-shore and companies are already responding.
For pharma organizations that are headquartered outside of America, there has been a renewed focus to look to Asia to expand their footprint in response to this. However, recent tariff announcements create future uncertainty for importing products from these locations…
Market-Leading Moves
Reshoring requirements create immediate cost pressures—revitalizing manufacturing approaches is the best way to keep costs low in a time when resources are already limited.
- Supply Chain Resilience: Implement strategies to make supply chains more resilient, such as diversifying suppliers, adopting modular manufacturing, and improving network visibility. Companies that create transparent, flexible supply networks will not only comply with reshoring mandates but also gain substantial advantages in speed-to-market and quality control across their operations.
- Investment in Technology: Invest in advanced manufacturing technologies to enhance efficiency and reduce costs. Organizations that leverage automation, AI, and modular production systems can offset reshoring cost increases while creating manufacturing capabilities that deliver sustainable competitive advantages through improved quality and operational flexibility.
The Pharma Opportunity
Reshoring presents both challenges and opportunities for pharmaceutical manufacturers. While initial transition costs may be significant, companies that approach this shift strategically can achieve better quality control, reduced transportation costs, and improved protection of intellectual property. Domestic production enables faster response times to market demands while spurring technological innovation. It is critical to have manufacturing operations that streamline validation processes, support production capabilities, and maximize these potential benefits of localized production.
Biosecurity and healthcare delivery
The administration's focus on biosecurity measures and a holistic approach to healthcare delivery could also shape the pharmaceutical market. Emphasizing nutrition, prevention, and longevity, the previous administration aimed to reduce the burden of chronic diseases. However, the new administration has already implemented policy changes that may alter the trajectory of these initiatives, impacting both biosecurity and healthcare delivery. For example, revoking U.S. participation in the World Health Organization (WHO) in January 2025. This move disrupts international disease surveillance networks and pandemic response capabilities, potentially affecting the global biosecurity landscape.
Market-Leading Moves
The shift toward prevention and holistic health creates new commercial imperatives for pharmaceutical companies that have traditionally focused on treatment rather than prevention:
- Innovative Product Development: Invest in the development of preventive treatments and wellness products that align with the administration's healthcare goals. Expanding your portfolio to include preventive therapies, nutraceuticals, and wellness solutions will capture emerging market segments in the evolution toward value-based healthcare.
- Collaborative Research: Collaborate with healthcare providers and research institutions to develop integrated healthcare solutions that address biosecurity and chronic disease prevention. Establishing these ecosystem partnerships early will gain you privileged insights into evolving care models and secure preferential access to emerging prevention-focused care pathways.
The Pharma Opportunity
The shift toward prevention and biosecurity opens real market opportunities for pharmaceutical companies. While some are already building food-as-medicine initiatives to gain early market position, others can leverage the administration's China policies to create more secure supply chains.
Success in this space demands concrete action. Companies need to revise R&D priorities, adapt commercial models, and build partnerships that extend beyond traditional pharmaceutical boundaries. Those who effectively bridge prevention and treatment won't just survive the changing healthcare landscape—they'll lead it and capture significant market advantage.
Final Thoughts
The pharmaceutical industry stands at a crossroads. Manufacturing reshoring, shifting compliance requirements, and new healthcare priorities demand immediate attention from industry leaders. Companies must make decisive moves rather than adopting a "wait and see" approach. Those who leverage these disruptions as catalysts for innovation will emerge stronger. By developing agile supply chains, maintaining robust compliance frameworks despite temporary enforcement pauses, and embracing prevention-focused product development, pharmaceutical companies can transform policy challenges into market opportunities.
