The Rise of Domestic Pharmaceutical Manufacturing: Seizing Opportunities Amid New FDA Initiatives

Introduction

The U.S. pharmaceutical landscape is undergoing a transformative shift with the FDA’s “FDA PreCheck” proposal, launched under Executive Order 14293 to bolster domestic manufacturing. With 53% of brand drug production currently overseas—95% of active pharmaceutical ingredients (APIs) sourced from China—this initiative aims to enhance national security and innovation by incentivizing U.S.-based facilities. As companies merge to combine biologics and diagnostics expertise, the opportunity is clear. Drawing on the Windshire Group’s experience, this post explores the potential and challenges of this reshoring movement and how bioscience firms can lead the charge.

The Push for Domestic Production

The reliance on foreign supply chains has exposed vulnerabilities, from tariff disruptions to quality control issues. The FDA’s PreCheck program offers streamlined inspections and financial incentives to bring production stateside, aligning with a broader push to reduce the 53% overseas manufacturing share. Industry momentum is building, with high-profile mergers signaling a strategic pivot. This shift promises a more resilient supply chain and faster market access for domestically produced drugs.

Opportunities for Bioscience Companies

Domestic manufacturing opens doors to significant advantages. Compliant U.S. facilities may see expedited approvals under PreCheck, cutting time-to-market for critical therapies. Localized supply chains can lower costs and enable innovation, especially with AI-driven manufacturing techniques. Moreover, the initiative supports job creation, boosting local economies and enhancing a company’s market position in an increasingly protectionist global landscape.

Hurdles to Overcome

However, the transition isn’t without obstacles. New PreCheck standards require facilities to meet rigorous regulatory benchmarks, demanding upgrades to infrastructure and processes. A shortage of skilled labor poses another challenge, while shifting supply chains risks temporary shortages of raw materials. Companies must navigate these hurdles carefully to avoid setbacks in production timelines.

Windshire’s Insights for Success

Engage Early with FDA and Shape the Program

• Participate in the Upcoming Public Meeting: Register for the FDA’s public meeting on “Onshoring Manufacturing of Drugs and Biological Products” scheduled for September 30, 2025, at the FDA White Oak Campus or virtually. Virtual options remain open until the event date). Use this forum to discuss program strengths, opportunities, and challenges directly with FDA representatives.
• Submit Public Comments and Feedback: Provide input on regulatory barriers, beneficial program elements, and ideas for incentives via the Federal eRulemaking Portal (Docket No. FDA-2025-N-2489) by October 30, 2025. Focus on specifics like willingness to share facility data in advance, confidentiality concerns, and suggestions for streamlining approvals (e.g., 90-day NDA/ANDA timelines). This can influence program refinements and demonstrate your organization’s commitment.
• Form Advocacy Coalitions: Collaborate with industry groups (e.g., via mergers combining biologics and diagnostics expertise, as noted in your query) to amplify feedback. Joint submissions can highlight shared challenges like cGMP compliance risks and push for clearer guidelines on required submissions.

2. Prepare Internally for Program Participation

• Assess and Upgrade Facilities for Domestic Readiness: Conduct an internal audit of current operations to identify gaps in U.S.-based manufacturing capabilities. Invest in facility design and construction that aligns with cGMP requirements, and prepare a “facility readiness dossier” including site layouts, quality systems, and maturity practices.
• Leverage Type V Drug Master Files (DMFs): Compile comprehensive facility-specific information (e.g., operations, Pharmaceutical Quality System elements) into a Type V DMF for early FDA review during the Facility Readiness Phase. Update this file throughout the lifecycle to incorporate by reference in applications, reducing redundancy. For biologics, navigate limitations by focusing on facility-only data to avoid BLA restrictions.
• Implement Digital Quality Management Systems (QMS): Adopt tools for regulatory compliance monitoring, quality metrics tracking, and proactive risk management. This aligns with the program’s emphasis on quality maturity and can streamline data sharing with FDA, enhancing predictability for capital investments.

3. Streamline Application and Operational Processes

• Map Chemistry, Manufacturing, and Controls (CMC) Narratives Early: During the Application Submission Phase, schedule pre-submission meetings with FDA to resolve questions proactively. Develop detailed CMC strategies, anticipate data needs, and plan inspections to accelerate reviews for new U.S. facilities.
• Identify and Mitigate Tech-Transfer Risks: For reshoring efforts, analyze potential issues in transferring production from overseas (e.g., quality control disruptions). Train staff for virtual FDA engagements and develop protocols for handling requests efficiently to minimize delays.
• Pursue Strategic Mergers and Investments: Consider merging or partnering with firms offering complementary expertise (e.g., biologics and diagnostics) to build resilient domestic supply chains. Use program incentives to justify investments, focusing on faster market access and reduced foreign dependency.

4. Monitor and Adapt to Program Evolution

• Track Updates and Pilot Opportunities: Stay informed via FDA announcements and industry analyses, as the program is still in draft form and may evolve based on feedback. Position your organization for potential pilot participation by demonstrating readiness in high-priority areas like critical medicines.
• Address Challenges Proactively: Mitigate risks like inspection complexities or confidentiality issues by building robust change controls and quality integrations early. For small and mid-sized firms, emphasize how PreCheck levels the playing field against larger players.

By implementing these strategies, organizations can not only comply with but lead in the reshoring movement, enhancing national security, innovation, and supply chain resilience. Success will depend on early action, especially with the public meeting approaching.

Furthermore, his recommendation to engage external experts can address technical gaps, leveraging Windshire’s cross-modal experience to streamline the transition.

Actionable Steps Forward

Biotech firms should start with feasibility studies to assess relocating or expanding U.S. production. Investing in AI and digital tools can position companies to meet PreCheck standards ahead of competitors. Collaborating with the FDA and industry peers can shape supportive policies, turning challenges into opportunities. Acting now is critical to capitalize on this strategic shift.

Conclusion

The rise of domestic pharmaceutical manufacturing in 2025 presents a pivotal moment for the bioscience industry. With FDA support and Windshire’s proven strategies, companies can seize opportunities while overcoming hurdles. Explore partnerships with quality system specialists and stay engaged with regulatory developments to lead this transformative era. The future of U.S. healthcare innovation hangs in the balance.

Do you need help with CMC challenges or FDA PreCheck strategy and implementation? Please contact Windshire at info@windshire.com or +1 844-686-5750 to determine how we can support your needs.