Drugmakers call for clarity as FDA reviews AI use in drug development

The US Food and Drug Administration is facing calls from major pharmaceutical groups and patient advocates to refine and expand its draft guidance on the use of artificial intelligence in drug and biologic development, with concerns ranging from labeling standards to third-party vendor responsibilities.

In comments submitted to the agency, trade groups including PhRMA and BIO supported the FDA’s risk-based approach but emphasized the need for greater clarity in how the guidance will be applied to different types of AI tools. There was broad agreement on the importance of a structured framework, but stakeholders warned that key elements of the guidance remain too vague to be workable in practice.

PhRMA urged the FDA to explicitly exclude AI models that do not influence patient safety, product quality, or study integrity from its regulatory remit. It also pressed for clearer definitions and a more predictable process, proposing a seven-step framework to assess the credibility of AI tools.