Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule

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June 26, 2024

About This Course

FDA’s Office of Prescription Drug Promotion’s (OPDP) primary goal is to provide general information to stakeholders about prescription drug promotion, and more specifically, about how the recently published final rule: “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN) affects promotion conducted by or on behalf of a drug’s manufacturer, packer, or distributor (“firm”).

The webinar will provide background information on prescription drug promotion, including different categories and types of promotion, as well as regulatory requirements for each. Interested parties will then learn about the CCN final rule, including the five standards associated with the rule and the rule’s compliance date. Finally, the speaker will note available FDA resources to assist firms in complying with the CCN final rule and applicable requirements for prescription drug promotion.

The information presented can be used to gain a general understanding about prescription drug promotion and applicable requirements. In addition, participants will utilize the information to understand the effect the final rule has on DTC prescription drug advertising in TV or radio format. Attendees will be able to apply the information to help ensure the presentation of the major statement in their ads complies with the CCN rule.

Intended Audience

• Drug manufacturers, packers, or distributors that promote their prescription drugs (NDAs, BLAs, and ANDAs) to consumers, patients, and caregivers
• Advertising firms that create prescription drug advertisements
• Regulatory affairs professionals working on prescription drug promotion
• Regulatory affairs professionals who submit prescription drug promotional communications to FDA
• General public wanting a better understanding of prescription drug advertising and promotion

Topics Covered

• The Clear, Conspicuous, and Neutral Final Rule
• Prescription Drug Promotion
• FDA resources regarding prescription drug promotion

Resources

• CCN Final Rule
• CCN Small Entity Compliance Guide
• CCN Final Rule Frequently Asked Questions
• Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs
• OPDP webpage
• Advertising and Promotional Labeling Branch (APLB) webpage

visit the FDA.gov webpage