The AI Action Plan was initiated by Executive Order (EO) 14179, signed in January 2025, which directed the federal government to remove barriers to AI innovation and develop a national strategy.  Following a public consultation that generated over 10,000 comments, the plan was released in July 2025 with input from industry, academia, and government stakeholders.  The Action Plan introduces over ninety new federal policy initiatives with direct implications for biopharma, referencing the U.S. Food and Drug Administration (FDA) as a potential partner in supporting AI-driven innovation.

Structural Pillars and Policy Changes

  • The plan proposes regulatory sandboxes and AI Centers of Excellence, which agencies such as the FDA may support. These initiatives are intended to enable biopharma companies to test and validate AI tools under regulatory oversight, helping to foster a more innovation-friendly environment.
  • The National Institute of Standards and Technology (NIST) will develop domain-specific standards for AI systems, while the National Science and Technology Council (NSTC) will recommend minimum data quality standards for scientific datasets. NIST will also publish evaluation guidelines and support measurement science, which federal agencies—including the FDA—may use to create sector-specific evaluation frameworks.  This may lead to new expectations for transparency, traceability, and reproducibility of AI systems in Good Practice (GxP) environments in biopharma.
  • The plan supports investments in automated, cloud-enabled laboratories and advanced manufacturing technologies. This has the potential to enable transformation of advanced biopharma production and supply-chain practices.
  • The plan calls for a multi-tiered biosecurity framework and promotes global standardization, both of which could shape future FDA policies related to synthetic biology and data governance.

Implications for Biopharma

  • Regulatory Engagement: Participation in FDA-supported regulatory sandboxes allows biopharma companies to test and refine AI applications within a regulatory context, giving early insight and adaptability to evolving compliance frameworks.
  • Transparent and Traceable AI: Emerging evaluation frameworks, influenced by NIST and the FDA, are likely to raise standards for documentation, reproducibility, and explainable AI in GxP settings.

The AI Action Plan highlights several mechanisms that could impact biopharma R&D, compliance, and operational standards as policy details develop.  Recommended actions as the policy landscape evolves include:

  • Engaging with regulatory sandboxes where FDA oversight or guidance may be available;
  • Staying informed on the development of FDA-related guidelines and sector evaluation frameworks for AI in biopharma; and
  • Enhancing documentation and traceability to align with anticipated regulatory requirements for AI transparency and reproducibility.

Contact Lachman Consultants today at LCS@LachmanConsultants.com to learn more about how we can help your organization with the successful implementation of AI in this rapidly changing environment.