Pharmaceutical manufacturers and industry organizations are urging the U.S. Food and Drug Administration (FDA) to broaden the scope of its PreCheck program, an initiative designed to encourage domestic pharmaceutical manufacturing. Stakeholders argue that extending eligibility to include existing facilities—not just new ones—would accelerate the program’s impact and strengthen U.S. supply chain resilience.
Broadening the Program’s Reach
The PreCheck program, introduced by FDA Commissioner Marty Makary in August 2025, aims to streamline the approval process for companies establishing new manufacturing sites in the United States. However, more than 70 public comments submitted to the FDA suggest that limiting the program to new facilities may reduce its effectiveness.
The Biotechnology Innovation Organization (BIO) noted that expanding eligibility to include modernization or onshoring of existing facilities could “maximize the program’s impact in the short term” and ensure faster growth of domestic capacity. Similarly, the Bulk Pharmaceuticals Task Force (BPTF) and the Association for Accessible Medicines (AAM) emphasized that enabling currently dormant or underutilized plants to participate would allow production to ramp up more quickly than building entirely new sites.
According to BPTF, enhancing existing Good Manufacturing Practice (GMP) sites leverages established “quality culture” and minimizes the learning curve compared to new greenfield projects. AAM added that many U.S. facilities could restart production “far more quickly” with the right economic and regulatory incentives in place.
Strengthening Support for the Generic Sector
The generic drug industry continues to advocate for greater federal support beyond the FDA’s scope. AAM underscored a “profound economic imbalance” between branded and generic manufacturers and called for additional government initiatives to promote onshoring, incentivize modernization, and ensure long-term supply chain stability.
The group emphasized that true progress toward national resilience goals will require both regulatory and economic measures, such as tax incentives and manufacturing grants, to complement the FDA’s PreCheck framework.
Integrating with Other Modernization Efforts
Several stakeholders recommended that the FDA align PreCheck with other advanced manufacturing initiatives, including the Center for Drug Evaluation and Research’s Emerging Technology Team (ETT) and the Center for Biologics Evaluation and Research’s Advanced Technologies Team (CATT). BIO and the American Society of Gene and Cell Therapy (ASGCT) suggested that such integration would foster consistent regulatory expectations across platforms and support the adoption of innovative tools such as digital-twin modeling, predictive analytics, and continuous quality monitoring.
ASGCT also highlighted the potential benefits of connecting PreCheck with the Advanced Manufacturing Technologies and Platform Technologies designations to help derisk new approaches and encourage wider adoption across the biopharmaceutical landscape.
Addressing Data and Confidentiality Concerns
Industry groups such as PhRMA recommended reducing certain data burdens under PreCheck to accelerate participation, including fewer process performance qualification (PPQ) runs and shorter stability testing requirements. They noted that modern analytical technologies and real-time monitoring now provide greater insight into manufacturing consistency than traditional methods.
Meanwhile, ASGCT raised questions about data confidentiality under the Freedom of Information Act (FOIA), urging the FDA to establish clearer guidelines that protect proprietary manufacturing data while maintaining transparency in facility-level GMP compliance.
The Path Forward
Expanding the PreCheck program could mark a pivotal moment in the FDA’s efforts to strengthen domestic pharmaceutical manufacturing. By incorporating existing facilities, harmonizing with complementary initiatives, and addressing confidentiality and data-sharing concerns, the agency can enhance supply chain security and promote innovation across the industry.
At EMMA International
At EMMA International, we understand the importance of regulatory agility and manufacturing resilience in today’s evolving pharmaceutical landscape. Our experts partner with clients to develop and modernize facilities that meet FDA expectations, implement advanced manufacturing technologies, and maintain full compliance with cGMP requirements.
Whether you are building a new facility or repurposing an existing one, EMMA International offers end-to-end support in quality management, validation, and regulatory strategy to ensure readiness under programs like FDA’s PreCheck initiative.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
U.S. Food and Drug Administration. Public Comments on the PreCheck Program Proposal. (October 2025).
Regulatory Affairs Professionals Society (RAPS). Pharma Groups Seek Expansion of FDA’s PreCheck Program. (November 2025).
