On Tuesday, September 9, 2025, the FDA announced plans to ramp up enforcement with respect to prescription drug advertising, issuing both cease-and-desist and warning letters to pharmaceutical companies whose advertisements the agency deemed misleading or insufficiently transparent. In addition, the agency announced the beginning of a process to update requirements around the “adequate provision” rule that allows marketers to direct patients elsewhere for additional disclosures. While these changes represent a significant shift, firms can take steps to align with current policy and prepare for future enforcement.

Considerations for Pharmaceutical Marketers

Audit all advertising channels

Review TV, print, digital, and social media campaigns for compliance with FDA standards. Risk information should be presented with the same visibility and clarity as efficacy claims. With the agency signaling more scrutiny on digital platforms, influencer content, and online channels deserve particular attention. The FDA cited a 2024 review in the Journal of Pharmaceutical Health Services Research in its press release, stating, “while 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms” and that “88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.”

Enhance risk disclosure in ads

For any prescription drug ads or campaigns, firms will need to focus on enhancing risk and limitations disclosures. Currently, the FDA states that “…advertisements present a fair balance between a product’s risks and benefits; avoid exaggerating benefits; not create a misleading overall impression; properly disclose financial relationships; and include information regarding major side effects and contraindications.”

The FDA has been lax in recent years with enforcing these requirements, so firms will need to be prepared for the upcoming shift. One way to be proactive will be to partner with agencies to bring more comprehensive risk information directly into the advertising itself, rather than relying on fine print or external links. This may mean exploring longer video spots or interactive ad formats that balance creativity with compliance. These changes may drive up placement costs but will reduce regulatory exposure and strengthen credibility with patients.

Leverage OPDP’s voluntary review process

While most teams are not required to submit ads for FDA review in advance (outside of accelerated approval contexts), many can benefit from the Office of Prescription Drug Promotion’s advisory review. OPDP targets a 45-day review window following a 5-day administrative screening. In practice, launch teams should build in six to seven weeks for feedback. This extra time allows room for agency input and reduces the likelihood of disruptive enforcement after launch.

What does this mean moving forward?

Looking ahead, the FDA’s message is clear: expect faster, broader enforcement of promotional practices while formal rulemaking moves forward. The “adequate provision” standard is under review, and new requirements could take a year or more to finalize.

By acting now – whether it’s tightening disclosures, planning for longer review cycles, or strategically rethinking ad formats, pharmaceutical marketers can not only reduce immediate risk but also stay ahead of what’s likely to be a more demanding regulatory environment in the years ahead.

Reach out to our team to chat more.