2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

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.

FDA Tightens the Reins on DTC Drug Advertising

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.

What This Means for DTC Drug Ads in 2026

MLR and Promotional Review Committees (PRCs) should expect continued, and potentially intensified, oversight. Key areas of focus include:

• Clear, Conspicuous, and Neutral (CCN) presentation of risk information, including proper dual-modality delivery (audio and on-screen text).
• Visual and audio balance, ensuring imagery, animations, or characters do not distract from or undermine the major statement.
• Substantiation of claims, particularly those related to magnitude of benefit, time to onset, or quality-of-life improvements.

Bottom line: FDA is signaling that promotional missteps will not be overlooked. Promotional materials must be rigorously substantiated, balanced, and executionally sound.

Navigating FDA Leadership Changes and Layoffs

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.

What to Watch for in 2026

• Permanent OPDP leadership appointments may offer insight into future policy direction and enforcement priorities.
• Resource constraints and hiring delays could affect advisory review timelines and lead to variability in feedback.

CDER Guidance Shake-Up: Preparing for Policy Uncertainty

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.

Draft Guidances to Monitor Closely

Regulatory and compliance teams should keep a close eye on the status of several influential OPDP draft guidances, including:

• Presenting Risk Information in Promotion
• Responding to Unsolicited Off-Label Requests
• Postmarketing Submissions for Interactive Media
• Distributing Scientific Publications on Risk Info
• Social Media Platforms with Space Limits
• Brief Summary & Adequate Directions for Use

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.

Inside FDA Guidance Documents: Key Developments to Know

Scientific Information on Unapproved Uses (SIUU)

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:

• SIUU communications must remain non-promotional, factual, and neutral.
• Content should be supported by published, peer-reviewed literature or authoritative clinical references.
• Firms should proceed cautiously until implementation requirements are finalized.

If the guidance is withdrawn, companies should be prepared to halt SIUU communications immediately.

Biosimilar Promotion Guidance Finalized

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:

• Confirmation that recommendations apply across all media types.
• Expanded guidance on biosimilar-to-reference product comparisons.
• Clarifications around labeling presentation and information consistent with labeling (CFL).

Bottom line: While changes were modest, the guidance reinforces FDA’s expectations for accurate, balanced, and non-misleading biosimilar promotion.

Partnering for Promotional Confidence in 2026

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.