From Risk to Readiness in 2026
How AI Compliance Checks Will Keep Companies Ahead of FDA Scrutiny, GenAI Growth, and Retail Drug Dispensing
2026 is shaping up to be a defining year for how AI intersects with regulatory compliance in life sciences. As industry innovation accelerates, three forces are converging to dramatically expand where, when, and why AI-powered content checking will become essential.
1. Regulatory Scrutiny Will Intensify — and New Eyes Are Surveilling
In September 2025, the U.S. FDA launched a major enforcement campaign targeting direct-to-consumer (DTC) pharmaceutical advertising that misleads patients or downplays risks. Following a September 2025 presidential directive, the agency announced hundreds of enforcement actions—including over 100 cease-and-desist letters—signaling a zero-tolerance stance toward unbalanced or deceptive ads. While most of the letters focused on DTC content, FDA also sent letters for health care professional (HCP) promotion. The message: Government scrutiny and enforcement will significantly increase for biopharma as well as medical device promotion. This new standard will be strictly enforced by the younger corps of regulatory professionals at the FDA who have been recruited to keep pace with rapidly evolving science, technology, and promotional practices, filling vacancies caused by the pandemic.
2. Generative AI Will Create More Content — With More Scrutiny to Get it Right
Generative AI is rapidly transforming how life-sciences companies create content, enabling pharmaceutical, biotech, and medical-device organizations and their promotional agencies to produce marketing materials, medical education resources, and patient-facing content in seconds rather than weeks. But as GenAI scales, it also creates exponentially more language that must be governed. A single shift in phrasing can change meaning, imply superiority, broaden an indication, or weaken fair balance. GenAI is built to generate, not to enforce accuracy, consistency, or compliance, which means every accelerated output increases the responsibility to ensure alignment with labeling, evidence, and regulatory expectations. This makes AI-powered checking indispensable as a trusted “second opinion”—able to validate scientific accuracy, verify references, assess consistency, and provide auditable reasoning at scale. GenAI will not eliminate review; it will elevate the need for governed, intelligent review systems that preserve speed while protecting regulatory defensibility, scientific credibility, and patient trust.
3. Foundational AI Literacy Will Become a Requisite for Business Success
Regulators, MLR reviewers, brand teams and their marketing agencies need a shared language about AI itself, so all industry stakeholders understand that AI isn’t one thing. Rather, AI is a coordinated set of analytical, rules-based, generative, and retrieval-driven methods that—when integrated and have humans in the loop—create a controlled, dependable, and transparent way to automate manual tasks at speed without sacrificing accuracy. MLR teams already see how AI can improve efficiency, but without understanding the building blocks of AI, the accuracy part of the value equation is missing. Teams want to know why AI output can be trusted, not just that it was generated quickly.
2026 is shaping up to be a defining year for how AI intersects with regulatory compliance in life sciences. As industry innovation accelerates, three forces are converging to dramatically expand where, when, and why AI-powered content checking will become essential.
About SecureCHEK AI
SecureCHEK AI is a Software-as-a-Service (SaaS) system that seamlessly integrates with enterprise platforms to enhance MLR efficiency. Purpose-built for pharmaceutical and medical device companies, the software helps MLR reviewers efficiently assess and mitigate compliance risks and reduce comments and re-reviews.
As the first Analytical AI software solution for pre-MLR use in life sciences, SecureCHEK AI leads the way in integrating Analytical AI with GenAI to mitigate hallucinations for the greatest confidence and trust in the findings. Rapid deployment and the user-friendly interface minimize the learning curve, making it easy to get started.
Contact us for a demo to learn how SecureCHEK AI builds libraries and executes prechecking.