The data: Two-thirds (65%) of pharma marketers are wary of AI use for creating regulatory filings, according to a new Klick Health and Momentum Events survey. Momentum conducted an online survey of 40 pharma marketing and review professionals from July to October 2025.

• 40% said AI hallucinations were their top concern, while 20% noted the lack of an audit trail, and 12.5% cited a lack of transparency or explainability.
• However, half of them said they do trust AI for doing reviews of regulatory materials.

Why it matters: Drug companies are starting to use generative AI (genAI) to help write the required paperwork they submit to regulators (like the FDA), with a goal to speed up drug approvals and reduce mistakes.

• 55% of participants said their organizations are exploring AI for review purposes, and another 25% said they are already testing it.
• Only 7.5% have fully or partly implemented AI for regulatory review.
• 12.5% said they’re not considering AI for those purposes.

Meanwhile, the FDA has added its own genAI tools and processes to speed up its review of drugmaker and medical device regulatory submissions, and named its first chief AI officer in May.

Implications for pharma marketers: AI-assisted review is likely to become a standard part of regulatory workflows for both industry submissions and agency evaluations. However, human oversight will remain important. Valid concerns around hallucinations, bias, and traceability mean that inadequate AI monitoring could slow reviews, trigger additional documentation requests, or even jeopardize approvals.