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Advertising and Promotion Regulatory Affairs Conference
Session 5: Engaging with Patients to Diversify Advertising and Promotional Activities
Joanne Hawana, JD, MS
- Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
Medical product developers are interacting with patients and caregivers more than ever before in unique and diverse ways, from recruiting clinical trial subjects through social media outlets to providing educational information about complex therapies or diseases. This area of focus has accelerated in recent years as FDA and other regulators encourage “patient-focused” drug and medical device product development. Patients are also more likely to be involved in their healthcare plans today than ever before, and they seek out medical knowledge from a variety of sources, including pharmaceutical and medical device companies developing products for their specific disease or condition but also patient organizations, government sources, and elsewhere. Although there are numerous opportunities for companies to engage directly with patients and caregivers, there also are legal and regulatory risks and barriers to certain activities and limitations on what companies can communicate to consumers as part of these activities. This session will explore the opportunities and challenges associated with companies’ outreach to patients and caregivers. We will also discuss ways to ensure such activities do not run afoul of regulatory requirements and provide tips to ensure promotional efforts that incorporate patient-derived information remain in compliance with applicable laws.
Learning Objective :
- Articulate opportunities and compliance risks associated with different forms of patient engagement
- Discuss mechanisms for ensuring patient-facing materials that are not clearly promotional in nature (e.g., clinical trial recruitment notices, educational content) do not violate applicable laws and regulations
- Identify potential regulatory violations when presented with case studies of promotional materials involving patient-derived information
Pamela Goldberg, MBA
- President and CEO
- Medical Device Innovation Consortium, United States
Minerva Hughes, JD, PhD
- Regulatory Counsel, Office of Clinical Evidence and Analysis
- CDRH, FDA, United States
Lisa J Pieretti, MBA
- Executive Director; Co-Founder
- International Hyperhidrosis Society, United States