Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad and Promo Rules – Webinar Recording/Transcript
Can you avoid social media’s serious challenges?
Modern communication platforms, the use of patient influencers, healthcare provider endorsers and brand ambassadors allow pharma and medical device companies to reach consumers directly in new, transformative ways.
But the FDA and FTC are putting renewed attention on such communications, regularly citing companies for promotional violations. Meaning you could be next for an untitled letter, warning letter … or worse.
This presentation is your answer.
It will provide you with the must-know legal, regulatory and practical considerations associated with using such tools, so you can reach consumers directly while avoiding negative consequences.
In addition to dos and don’ts, the two presenters — partners in Ropes & Gray’s Life Sciences Regulatory and Compliance practice group — will lead a thorough discussion of best practices using case studies. Kellie Combs, also cochair of the firm’s crosspractice Digital Health group, and Josh Oyster will explain how to navigate the gray areas and manage risk so you can optimize consumer engagement in a compliant way.
- The regulatory framework and enforcement landscape — including relevant FDA guidance and recent Office of Prescription Drug Promotion (OPDP) warning and untitled letters — that is generally applicable to online and social media communications
- When the FDA or FTC may consider online or social media content to be attributable to a product manufacturer, including considerations related to posts by company leadership and other personnel as well as healthcare professionals and patients who are connected to the company
- Distinctions between promotional and nonpromotional communications on social media and the legal requirements and special considerations that apply to each, such as content, tone and disclaimers
- How to convey key product information and engage with consumers in a compliant way, including by using consumer-friendly language and presenting safety and risk information across a variety of online and social media platforms
- Considerations for a risk-based, practical approach to managing risk online and in your social media communications, including those related to product profile, novelty and frequency of information provided, and monitoring of user-generated content, among others
The FDA’s next untitled or warning letter could be addressed to you. Ensure your direct social media consumer communications are compliant.
Meet Your Presenters
Kellie Combs is a partner in Ropes & Gray’s Life Sciences Regulatory and Compliance practice group and is also a cochair of the firm’s crosspractice Digital Health group. She provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as hospitals and academic institutions, on a broad range of issues under the Food, Drug and Cosmetic Act and the Public Health Service Act. Ms. Combs has extensive experience handling matters related to FDA promotional rules and the First Amendment and has advised on a number of government investigations of FDA-regulated companies.
Josh Oyster is a partner in Ropes & Gray’s Life Sciences Regulatory and Compliance practice group. He steers clients through a wide range of FDA regulatory issues and is regularly called upon for help with a range of enforcement, regulatory compliance and transactional matters. Mr. Oyster routinely helps companies navigate FDA inspections, warning letters, product recalls and other compliance and enforcement matters.
Who Will Benefit
- Regulatory Affairs Personnel
- Legal Personnel
- Compliance Personnel
- Digital Marketing Teams
- Product Marketers
- Sales and Commercial Operations Personnel
- Ad Agencies and Vendors
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April 28, 2022