65% of Pharma Marketers Distrust AI for Regulatory Compliance Submissions
A recent survey by Klick Health and Momentum Events reveals that 65% of pharmaceutical marketing and promotional review professionals in the U.S. do not trust AI for creating regulatory compliance submissions. The top concerns are hallucinations (40%), lack of traceability or audit trails (20%), and insufficient transparency or explainability (12.5%). These findings highlight growing skepticism about generative AI in high-stakes healthcare environments where accuracy and accountability are critical. Alfred Whitehead, EVP of Applied Sciences at Klick, emphasized the need for AI tools that offer visibility and accountability. He noted that black-box AI systems—those that deliver answers without revealing their reasoning—make it difficult to validate outputs, especially in regulated industries. Julie Turnbull, SVP of Science + Regulatory, pointed to glass-box AI as a viable alternative. These tools incorporate human expertise in medical and regulatory decision-making, providing clear logic, audit trails, and explainable workflows. Klick Guardrail™, a glass-box AI tool developed specifically for the healthcare marketing sector, exemplifies this approach. Unlike traditional AI that offers suggestions without context, Guardrail uses a proven decision engine to apply complex reasoning and document its logic. It supports compliance by enabling traceability across the medical, legal, and regulatory (MLR) review process. The tool is currently in pilot programs with multiple pharmaceutical and biotech companies and is already used internally at Klick to improve asset authoring, review, and compliance workflows. BJ Jones, Chief Commercial Officer at NewAmsterdam Pharma, praised Guardrail for making responsible AI both feasible and practical. Having served on the jury for the Klick Prize, he highlighted the tool’s thoughtful design, which embeds safety, transparency, and trust into its core functionality—respecting both reviewers and content creators. Survey results show that while half of respondents trust AI for reviewing materials, there is strong hesitation about using it for high-risk tasks like generating regulatory submissions. Over a third of companies review more than 100 promotional assets per quarter, underscoring the need for efficient, reliable tools. Despite this, only 7.5% of organizations have partially or fully deployed AI in their review processes, with 12.5% not considering AI at all. However, 55% are exploring AI, and 25% are in pilot phases, indicating growing interest. The findings align with broader concerns about AI reliability. A 2025 KPMG and University of Melbourne survey found that 62% of people are now worried about AI, up from 49% in 2022. More than half (56%) reported that AI use led to errors, often due to hallucinations or misinterpretation of AI outputs. Many employees are using AI in non-compliant ways, leading to dependency and policy violations. The survey, conducted from July to October 2025, included 40 U.S.-based professionals in the pharmaceutical marketing and review space. Respondents’ roles were primarily in MLR Operations/Management (35%), Regulatory (30%), Marketing (15%), Medical Affairs (12.5%), Legal (5%), and Technology (2.5%). These results underscore the urgent need for transparent, auditable AI systems in regulated industries. Glass-box tools like Klick Guardrail represent a promising shift toward responsible AI—one that balances innovation with compliance, accountability, and trust. As AI adoption grows in healthcare marketing, tools that prioritize explainability and traceability will be essential for maintaining regulatory integrity and public confidence.
