Navigate Industry Compliance with Confidence
The regulatory landscape for healthcare marketing is constantly evolving. New rules, updated guidance, and shifting enforcement priorities can create uncertainty for even the most experienced marketers. That's why we've created this resource center to help you stay informed, remain compliant, and market with confidence.
Understanding the CCN Final Rule
The FDA's Clear, Conspicuous, and Neutral (CCN) Rule represents one of the most significant changes to DTC prescription drug advertising in decades. Our guide gives you everything you need to understand and comply with these new requirements.
The FDA’s CCN Rule applies to full product claim ads (ads that include both the drug name and its uses):
- For human Rx drug ads
- Directed to consumers (“DTC”)
- In television or radio format*
The Reality
Though the CCN rule technically only applies to “broadcast” and “telephone communication systems” ads, we expect FDA to apply the rule to commercials on streaming platforms, social media, and smart/connected TVs.
FDA Has 5 Standards For The Presentation Of A CCN Major Statement
- Easy to Understand Language: The major statement should use words familiar to consumers, not medical jargon.
- Clear Audio: The spoken presentation of the major statement must be as clear as the rest of the ad in terms of volume, speaking speed, and pronunciation.
- Dual Modality in TV Ads: Both audio and text (captions) must be used at the same time to present the major statement.
- Easy-to-Read Text: The text size, font style, color contrast with the background, and placement on the screen must allow viewers to read the major statement information easily.
- No Distractions: The ad should not have any elements that could make it difficult to understand the major statement.
Understanding the FDA CCN Final Rule
Download our CCN Rule guide to access:
- Detailed breakdown of what the FDA regulates
- Which ads are covered (and which aren't)
- Official FDA resources and guidance documents
- Visual examples of all 4 types of drug ads
The New DTC Landscape: Policy Implications of the FDA CCN Rule
Industry experts Tish Pahl (Principal, OFW Law) and Jim Potter (Executive Director, Coalition for Healthcare Communications) cut through the confusion to deliver clear, actionable guidance on today's regulatory environment.
5 Things You Need to Know About the Policy Implications Reshaping the DTC Landscape
What You'll Learn:
- Separate fact from fiction: Understand which regulatory changes are real requirements versus common misconceptions
- Expert legal perspective: Get insider insights on the current enforcement landscape and what regulators are focusing on
Build your action plan: Access a practical compliance checklist you can implement immediately - Navigate future challenges: Learn proven strategies for staying ahead of regulatory changes