Navigating the “Clear, Conspicuous, and Neutral” DTC Prescription Drug Ad Final Rule for Agencies

On May 20th, the FDA’s direct-to-consumer prescription drug advertising final rule becomes effective, establishing new standards required for conveying information in a “major statement” relating to the applicable drug’s major side effects and contraindications in a “clear, conspicuous, and neutral manner” (CCN). For marketers, the days of speed-read, technical jargon disclaimers jammed in the last few seconds of Rx ads are now a thing of the past, and consumer-friendly language that is readily understandable now rules the day.

Learn more in our deep-dive conversation with the FDA about:

• What laws and regulations are driving prescription drug advertising?
• What prescription drug ads will be impacted by the CCN final rule?
• What are the specific CCN requirements of the final rule?
• When will enforcement begin, including actions for non-compliance?
• What FDA resources are available to assist agencies and manufacturers?

Speakers

Suzanna Boyle – Regulatory Council, Office of Medical Policy, Office of Prescription Drug Promotion @ U.S. Food and Drug Administration

Suzanna Boyle has been a Regulatory Counsel at the Food and Drug Administration for 10 years. For the last five years, she has been with the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research.  As a Regulatory Counsel in OPDP, Suzanna provides regulatory and legal guidance on compliance actions, advisory documents, and stakeholder inquiries regarding the promotion of prescription drugs. Suzanna is also the technical lead for the “Clear, Conspicuous, and Neutral” Final Rule and its related Small Entity Compliance Guide. Prior to joining OPDP, she spent five years with the Center for Tobacco Products, progressing to an Embedded Regulatory Counsel in the Office of Compliance and Enforcement. Suzanna provided legal and regulatory guidance to the Division of Business Operations, supporting the Civil Money Penalty, Hearings, and Settlement Teams with enforcing the Tobacco Control Act through retailer compliance actions. Before joining FDA, Suzanna worked as a Legislative Aide in the Maryland General Assembly. Suzanna received her law degree from UDC David A. Clarke School of Law.

Jim Potter – Executive Director @ Coalition of Healthcare Communication – Moderator

Jim Potter serves as the CHC’s Executive Director, a subsidiary of the 4A’s, representing medical publishers, communications and advertising companies to promote the free exchange of accurate, credible, and scientifically sound healthcare information. Jim previously served in executive and advocacy positions with national and state medical organizations. He has been awarded the FDA Commissioner’s Special Citation for coordinating a consensus approach on breast cancer quality standards. And his advocacy work was recognized by the American Society of Association Executives (ASAE) with its highest honor for advancing early detection and intervention for children with hearing loss. Jim received his graduate and undergraduate degrees from the University of Michigan.