Leen Kawas on America’s Pharmaceutical Manufacturing Renaissance: National Security Through Reshoring

Leen Kawas, a leading biotech professional, highlights ways in which the return of US manufacturing can be beneficial to the economy, the industry, and the overall wellness of individuals.

The United States is witnessing a significant shift in its pharmaceutical manufacturing landscape as companies increasingly move production operations back home after decades of offshoring. This reshoring movement, accelerated by recent global events and policy changes, represents a critical turning point for American healthcare security and economic resilience. According to biotechnology leader Leen Kawas, this trend marks an essential step toward strengthening the nation’s healthcare infrastructure.

“The vulnerabilities within our pharmaceutical manufacturing and supply chains were starkly exposed during recent global disruptions,” explains Leen Kawas, Managing General Partner at Propel Bio Partners. “Reshoring pharmaceutical production isn’t just economically beneficial — it’s a matter of national security that ensures Americans have reliable access to essential medications.”

A Dependency Decades in the Making

America’s reliance on foreign pharmaceutical manufacturing has grown dramatically since the 1980s. According to industry data from the Elangham Group, approximately 72% of active pharmaceutical ingredient (API) manufacturers supplying the U.S. market are based overseas, with China and India accounting for a substantial portion of this production. The U.S. pharmaceutical import market reached nearly $213 billion in 2024, representing more than two and a half times the total from a decade earlier, as reported by CNBC.

Leen Kawas points out that this dependency creates significant vulnerabilities: “When critical medications come predominantly from overseas, we’re exposed to supply chain disruptions from geopolitical tensions, transportation delays, and quality control issues. The COVID-19 pandemic clearly demonstrated how quickly these vulnerabilities can escalate into healthcare crises.”

This growing recognition has spurred action from both government and industry leaders. Recent legislation, including the CHIPS Act, the Inflation Reduction Act, and various executive orders, has created financial incentives for pharmaceutical companies to establish or expand domestic manufacturing capabilities, as detailed by Argonaut Manufacturing Services.

Current Reshoring Momentum

Several major pharmaceutical companies have already announced significant investments in domestic manufacturing facilities. Eli Lilly recently unveiled plans to construct four manufacturing sites in the United States at a cost of at least $27 billion, with three focused on producing active pharmaceutical ingredients, effectively bringing their small-molecule API production back to American soil, according to Pharmaceutical Technology. Similarly, Johnson & Johnson announced a $55 billion investment in U.S. manufacturing, research and development, and technology over the next four years, as reported by CNBC.

Leen Kawas notes that these investments reflect a fundamental shift in industry thinking: “Leading pharmaceutical companies now recognize that the benefits of domestic production — including supply chain security, quality assurance, and protection of intellectual property — outweigh the short-term cost advantages of overseas manufacturing.”

However, this transition isn’t without challenges. The pharmaceutical reshoring process is complex and multifaceted, often requiring five to ten years for full implementation, as noted by Medicine to Market. Companies must navigate regulatory requirements, secure adequate funding, develop specialized workforce capabilities, and establish local supply chains for raw materials and intermediate components.

Tariffs as Catalyst

President Trump’s recent trade policies have added new urgency to reshoring efforts. The administration has implemented broad tariffs affecting imports from multiple countries and has specifically targeted the pharmaceutical industry. While pharmaceuticals were initially exempted from the initial “Liberation Day” tariffs, the President has continued to signal that pharmaceutical-specific tariffs of “25% or higher” could be implemented in the near future, according to Fierce Pharma.

“The current administration’s tariff policies are accelerating decisions that many pharmaceutical companies were already considering,” says Leen Kawas. “While tariffs create immediate challenges for companies with global supply chains, they also create powerful incentives to invest in domestic manufacturing infrastructure.”

Industry experts note that these tariffs will likely drive increased investment in U.S. manufacturing facilities, but the transition will take time. According to Reuters, the Pharmaceutical Research and Manufacturers of America (PhRMA) has indicated it can take 5–10 years and $2 billion to bring on a new production facility in the U.S., partly due to stringent regulatory requirements.

Advanced Manufacturing: Enabling Reshoring Success

One of the key factors making pharmaceutical reshoring economically viable is the evolution of advanced manufacturing technologies. Traditional pharmaceutical manufacturing facilities require massive investments and large workforces, making them difficult to justify domestically when competing with lower-cost international locations.

However, innovations in continuous manufacturing (CM), 3D printing of pharmaceuticals, and other advanced manufacturing techniques are changing this equation, as highlighted by the Center for Strategic and International Studies. Leen Kawas emphasizes the importance of these technologies: “Advanced manufacturing enables greater production efficiency, reduces labor requirements, increases quality consistency, and ultimately makes domestic production economically competitive with international alternatives.”

These technologies provide substantial benefits beyond cost considerations. Continuous manufacturing, for instance, allows pharmaceutical companies to produce drugs in a constant stream rather than traditional large-scale batching. This approach enhances quality control, reduces waste, and facilitates faster responses to market demands — all critical factors for maintaining a resilient pharmaceutical supply chain, according to the Elangham Group.

Benefits Beyond Security

While national security and supply chain resilience are primary drivers for reshoring pharmaceutical manufacturing, Leen Kawas highlights additional benefits that extend throughout the American economy:

“Domestic pharmaceutical manufacturing creates high-quality jobs across the skill spectrum, from production line workers to specialized engineers and scientists,” notes Leen Kawas. “These jobs support local economies and help rebuild America’s manufacturing base, which has seen significant erosion over recent decades.”

Beyond employment benefits, reshoring also promotes innovation by bringing production closer to research and development centers. This proximity facilitates faster iteration, more efficient knowledge transfer, and ultimately accelerates the development of new therapies, as noted by RBC Capital Markets. The environmental impact is another consideration, as reduced transcontinental shipping minimizes the carbon footprint associated with pharmaceutical production and distribution.

Quality control represents another significant advantage. Domestic facilities face more frequent FDA inspections and must adhere to stringent U.S. regulations, potentially reducing contamination risks and ensuring higher product quality, according to knowledge@Wharton. This enhanced oversight helps protect patient safety and builds public trust in pharmaceutical products.

Challenges and Considerations

Despite the compelling case for reshoring, significant hurdles remain. The higher costs of domestic labor, stricter environmental regulations, and substantial capital investments required for new facilities present formidable challenges for companies considering reshoring initiatives, as detailed by Pharma Manufacturing.

“We must recognize that reshoring isn’t simply about relocating final production steps to the United States,” says Leen Kawas. “A true reshoring strategy requires developing local sources for raw materials and intermediate components. Otherwise, we’re merely shifting our vulnerabilities upstream in the supply chain.”

Workforce development represents another critical challenge. After decades of offshoring, the specialized skills required for pharmaceutical manufacturing aren’t readily available in many American communities, as highlighted byPharmaphorum. Addressing this skills gap requires investments in education, training programs, and partnerships between industry and academic institutions.

A Strategic Imperative

Despite these challenges, Leen Kawas maintains that reshoring pharmaceutical manufacturing represents a strategic imperative for both individual companies and the nation as a whole. The combination of national security concerns, technological advancements, and government incentives has created a unique opportunity to rebuild America’s pharmaceutical manufacturing capabilities.

“Companies that proactively invest in domestic manufacturing capabilities will be better positioned to navigate an increasingly unpredictable global environment,” concludes Leen Kawas. “By building resilient, flexible supply chains with strong domestic components, pharmaceutical manufacturers can ensure product availability while potentially gaining competitive advantages through enhanced quality, reliability, and innovation.”

As reshoring efforts continue to accelerate, America’s pharmaceutical supply chain is poised for a significant transformation — one that promises greater security, resilience, and self-sufficiency. While the journey may be lengthy and complex, the potential benefits for national security, public health, and economic prosperity make it a compelling path forward for the pharmaceutical industry.

This story originally appeared on https://www.laweekly.com/leen-kawas-on-americas-pharmaceutical-manufacturing-renaissance-national-security-through-reshoring/