FDA Ambitious Regulation of Social Media and Corporate Responsibility

Why Should You Attend:

The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. Through this webinar, participants will learn how to navigate FDA’s interpretations and expectations about a firm’s marketing practices through social media. Applying a new guidance and related guidance documents becomes a new test of the FDA’s legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys and whether it ultimately violates the law.

This webinar will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept when it uses social media. Attendees will see how a firm’s regulatory profile requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. They will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. And above all, attendees will also begin to apply the boundaries the FDA uses now and understand how easy it is to promote yourself into a corner.

Learning Objectives:

• Learn how the FDA interprets advertising and promotion in principle and in fact
• Understand the ways a firm triggers a violation due to its social media practices
• See how sales and marketing departments play a central role, for better or worse
• Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices

Areas Covered in the Webinar:

• FDA labeling vis-à-vis promotion and advertising via social media
• Direct to consumer marketing issues
• Fair and balanced information considerations
• Context of messaging and target population
• Exemptions for social media use
• Management roles and responsibilities

Who Will Benefit:

• Sales and marketing executives and managers
• Regulatory managers
• In-house legal counsel and contract specialists
• Third party consultants
• Owners and executive managers of new or developing firms of new or developing firms
• Own label distributors
• International trade managers
• Product specification developers

Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Frequently Asked Questions:

1. Are all posts on social media assumed to be direct to consumer? Is it platform specific or based on the post?
2. Can you use pinned posts to represent some of the conveyance of drug risks?
3. What is going too far with imaging? If a product supports a healthy weight, is it ok to show someone standing on a scale? If it is an immune product, is it ok to show pictures of viral particles?
4. Is FDA continuing to apply a stricter standard against Rx with a boxed warning in social as they have historically done in traditional promotion and advertising. Or is FDA willing to work with the limitations of social platforms?
5. for an obesity product, it's common for patients to post weight-loss journeys on social media. Is the manufacturer now required to ask all these patients to post fair balance on all posts?
6. To what extent is FDA preoccupied more with medications/medical products vs. nutritional products and supplements in terms of these regulations?
7. If a doctor posts off-label use for a drug on their own platform, or speaks to off-label use in a non-sponsored event, is that something the manufacturer should address?
8. To what extent is manufacturer required to monitor or address comments added by a user when sharing a post from manufacturer's site?

Topic Background:

The FDA’s regulation of promotion and advertising practices via social media jumps into a gray area of who is responsible for what people say, imply or represent without falling under the FDA’s jurisdiction. The snare for manufacturers is trying to identify their regulatory obligations for what other people say or claim in a public forum. Is there a difference in who that relates to freedom of speech of a person versus what becomes redefined as commercial speech? That’s a vague line. It can place a manufacturer into a big brother role. How can a manufacturer undo or counter a message that has already taken on a life of its own? The horse is out of the barn.

Firms need to identify practical criteria to make marketing decisions, define roles and apply more sophisticated concepts about how people are receiving and process information that drives their decision making and motivation. Relative to longstanding labeling and off-label concerns, the use of social media provides new marketing opportunities and, likewise, new ways to run into trouble with the FDA. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach a reasonable common ground on a marketing plan using social media. Do you have internal marketing guidelines for products that are directly or indirectly marketed? How can you impose fair and balanced information on consumers who are not subject to the FDA’s regulation?

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