Premier responded to the FDA’s discussion paper on AI in drug manufacturing, which articulates FDA’s vision to support innovation, build resiliency in the drug supply chain and close regulatory gaps and procedural pitfalls at a commensurate pace with evolving AI/machine learning (ML) technology. In our comments, Premier applauds the FDA’s efforts to incorporate emerging technologies into drug development and provide clarity for manufacturers. Specifically, Premier recommends that FDA:
- Harmonize current regulations and guidance with principles of responsible AI in order to minimize confusion and disruptions that impede drug development and manufacturing;
- Identify clear data quality guidelines for the use of AI in drug manufacturing processes;
- Clarify and bolster cybersecurity standards;
- Ensure that any future AI standards adequately mitigate risks of bias and promote transparency and explainability; and
- Enable the development of standardized intended use certifications or reporting requirements for AI technologies, which would prevent new systems from producing harmful outcomes due to use outside of the technology’s design.