Evidence-Based Engagements and Communications in Response to an Ever-Changing External Environment

In a leading article of the Pharmaceutical Advertising 2025 22^nd Edition, Ropes & Gray LLP partners, Lincoln Tsang, Kellie Combs, and Katherine Wang provide a comprehensive overview of evolving global standards in the United States, Europe, and key Asian jurisdictions. This publication underscores a marked shift towards evidence-based, patient-centric communication, driven by technological advances, increased patient empowerment, and a growing demand for transparency and accountability in healthcare communications.

In the United States, the Food and Drug Administration (FDA) has finalised guidance on scientific information on unapproved uses (SIUU) of approved or cleared medical products. This guidance clarifies the boundaries for non-promotional communication of information from off-label reprints, clinical practice guidelines, and other clinical practice resources directed at healthcare professionals (HCPs) involved in clinical decision-making. While the FDA guidance contemplates dissemination of truthful, non-misleading, and unbiased scientific information, the agency expects that the information will constitute "scientifically sound" evidence, which is not clearly elucidated in the guidance. The guidance also sets out detailed recommendations for disclosures and presentation, including the need to contextualise data and highlight conflicting evidence. However, the proliferation of new evidentiary standards—such as those for communications consistent with FDA-required labelling—creates compliance complexity for firms.

Europe continues to interpret "advertising of medicinal products" broadly, focusing on the effect of communications on prescribing or purchasing behaviour. Off-label promotion remains strictly prohibited, and the regulatory framework distinguishes between promotional and purely informative, non-promotional communications. Recent legislative developments and European Court of Justice rulings reinforce the need for objective, verifiable evidence to support claims and protect public health to ensure rational use of medicines. Europe is also moving towards a more holistic approach to clinical evidence generation, recognising the limitations of randomised controlled trials and the value of real-world data.

In Asia, regulatory regimes remain highly restrictive regarding off-label promotion. China and Singapore, for example, maintain stringent prohibitions, with severe penalties for unauthorised recommendations. Japan also enforces strict rules, particularly concerning the content and presentation of pharmaceutical advertising to the public.

This publication also highlights recent developments in the US around direct-to-consumer (DTC) advertising, with increased scrutiny of celebrity endorsements and risk disclosures. Globally, the convergence of regulatory expectations is fostering greater transparency, patient involvement, and the need for robust, scientifically substantiated communications. However, the diversity of evidentiary standards and the rapid evolution of digital and social media platforms continue to pose significant compliance challenges for the pharmaceutical industry.