Risks of Social Media Communication: A Guide to FDA and FTC Enforcement
Fail to exploit social media’s ability to communicate more directly and efficiently with patients and healthcare providers, and you miss out on sales.
But go too far and you risk an FDA untitled or warning letter. Navigate this environment easily with Risks of Social Media Communication: A Guide to FDA and FTC Enforcement.
With the FDA and FTC focusing more on your use of social media — and accelerated enforcement action for related promotional violations — you can’t afford to go without this clarification of what can be extremely complicated areas.
Drawing on a recent FDAnews webinar featuring two Ropes & Gray partners deeply engaged in health science regulatory issues and challenges, Risks of Social Media Communication will enable you to navigate the gray areas and manage risk so you can optimize direct-to-consumer engagement without triggering enforcement action.
Is it company leaders who make all your social media posts or do you rely on patient influencers, healthcare provider endorsers and brand ambassadors? Enforcement may be affected by exactly who is making the post. Risks of Social Media Communication sheds light on what you must know and do to stay compliant.
This report clarifies the FDA and FTC regulations that affect your use of social media, explains how the agencies are currently enforcing their regulations and includes key FDA guidance and details from recent warning and untitled letters.
And it will show you practical considerations that must accompany social media use, including a set of best practices and tips on specific steps you can take to ensure you’re compliant.
- Details from recent Office of Prescription Drug Promotion (OPDP) warning and untitled letters that illustrate how the existing regulations are applied in practice to drugmakers’ social media activity
- Exactly when the FDA or FTC considers online or social media content to be attributable to a product manufacturer, including noncompany personnel who may still have ties to the product manufacturer
- How to make the best use of patient and healthcare provider testimonials — and when regulators may consider such statements to be the same as if the company itself made them
- How to distinguish between promotional and nonpromotional communications on social media as well as the legal requirements and special considerations that apply to each, such as content, tone and disclaimers
- How to use consumer-friendly language to present information — including safety and risk considerations — across a variety of social media platforms
- Key considerations for applying a risk-based approach to managing online and social media communication risks, such as product novelty, the frequency of information provided and monitoring of user-generated content, among other factors
If you want to fully take advantage of direct-to-consumer social media — and stay compliant — you need Risks of Social Media Communication: A Guide to FDA and FTC Enforcement.
About the Contributors
Kellie Combs is a partner in Ropes & Gray’s Life Sciences Regulatory and Compliance practice group and is also a co-chair of the firm’s cross-practice digital health group. She provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, 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 and compliance
- Digital marketing teams
- Product marketers
- Sales and commercial operations
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Kellie Combs and Josh Oyster
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