2025 was a year of significant regulatory disruption. One that will have lasting implications for how pharmaceutical companies approach advertising and promotion in 2026. From an unprecedented surge in FDA enforcement activity to leadership turnover within the Office of Prescription Drug Promotion (OPDP) and growing uncertainty around long-standing draft guidances, the compliance landscape is shifting quickly.
Looking back on some of the most consequential regulatory developments of 2025 is critical to understand what medical, legal, and regulatory (MLR) teams should be prioritizing as you plan for the year ahead.
One of the most notable developments of 2025 was FDA’s renewed enforcement focus on prescription drug promotion. Beginning in September, the Agency launched a broad crackdown on advertising practices, issuing more than 70 enforcement letters across both consumer- and healthcare professional (HCP)-directed materials.
While DTC television advertising drew particular scrutiny, enforcement actions extended well beyond broadcast media. FDA cited violations across HCP websites, corporate webpages, influencer content, earned media placements, and patient testimonials, underscoring that all promotional channels remain firmly within OPDP’s scope.
MLR and Promotional Review Committees (PRCs) should expect continued, and potentially intensified, oversight. Key areas of focus include:
Bottom line: FDA is signaling that promotional missteps will not be overlooked. Promotional materials must be rigorously substantiated, balanced, and executionally sound.
Regulatory uncertainty was further compounded by leadership turnover and staffing changes within FDA in 2025. Following organizational restructuring in April, OPDP experienced the departure of several senior leaders, contributing to broader concerns about continuity and capacity within the Agency.
At the Center for Drug Evaluation and Research (CDER), the appointment of an Acting Center Director has provided some stability, but staffing challenges persist across multiple divisions.
Looking ahead, FDA guidance development may face additional headwinds. In January 2025, the White House issued the "One-in-Ten-Out" Executive Order, directing federal agencies to withdraw ten existing rules or guidances for every new one issued.
Although implementation details remain unclear, the policy has raised concerns that long-standing draft guidances, particularly those more than a decade old, could be withdrawn with little notice. At the same time, agencies have been given flexibility to classify certain documents as deregulatory actions, allowing them to bypass withdrawal requirements.
Regulatory and compliance teams should keep a close eye on the status of several influential OPDP draft guidances, including:
Compounding this uncertainty, OPDP’s Policy Division was eliminated in April 2025, limiting FDA’s capacity to issue new guidances and potentially slowing advisory review timelines.
Bottom line: Fewer guidances, slower reviews, and the risk of sudden withdrawals mean proactive monitoring and contingency planning are essential for 2026.
In January 2025, FDA issued its final guidance on communications to HCPs regarding scientific information on unapproved uses. While the guidance is technically final, it is not yet fully implemented due to the absence of a required Office of Management and Budget (OMB) control number.
Key considerations include:
If the guidance is withdrawn, companies should be prepared to halt SIUU communications immediately.
In December 2025, FDA finalized its guidance on promotional labeling and advertising considerations for reference biologics, biosimilars, and interchangeable biosimilars. The final version closely mirrors the April 2024 draft, with several important clarifications.
Highlights include:
Bottom line: While changes were modest, the guidance reinforces FDA’s expectations for accurate, balanced, and non-misleading biosimilar promotion.
As regulatory scrutiny intensifies and guidance uncertainty grows, having experienced promotional review support is more critical than ever. ProPharma delivers the industry’s most comprehensive Advertising and Promotional Review solutions, integrating regulatory, medical, legal, and operational expertise into a seamless global model.
Looking ahead to 2026, certainty matters. ProPharma is here to help you achieve it. Our end-to-end approach helps organizations navigate enforcement risk, adapt to evolving FDA expectations, and bring compliant, effective promotional materials to market with confidence.