Correcting Misinformation On Social Media Sites: Should ... · © 2015 EPSTEIN BECKER & GREEN,...

Correcting Misinformation On Social Media Sites: Should You Do It and How? Bradley Merrill Thompson

Regulatory Framework

Guidance

Topics for Discussion

Case Studies

Brad’s Guidelines

I feel like Zsa Zsa Gabor’s fifth husband. I know what I'm supposed to do

but I don't know if I can make it interesting. Al Gore

Part One: Regulatory Framework

It’s good to know the basics

From SignSpotting by Lanksy

1. “Labeling” may not be “false or misleading in any particular”

2. A manufacturer must limit it's intended uses to those that are lawful

• Intended use is not limited to what is revealed in “labeling”

Fundamental legal requirements

“Labeling” is:

all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

“Accompanying": Is interpreted liberally to mean more than physical association with the product

Extends to posters, pamphlets, etc., depending on how they are used

Includes labeling that is brought together with the device after shipment.

Can also include website content and other information a manufacturer posts online

But what of a tweet or a post on a discussion board?

Definitions

The term misbranded means:

“False or misleading in any particular.”

False generally is understood to mean a statement that in any material respect is untrue

Misleading is less clear

Fundamental Prohibition

Truth in Advertising

Funky.co.uk

Examples of false labeling include:

Unsubstantiated claims of therapeutic value

Examples of misleading labeling include:

Ambiguity, half-truths, and trade puffery

Expressions of opinion or subjective statements

Failure to reveal material facts, consequences that may result from use, or the existence of difference of opinion

Fundamental Prohibition

Just Opinion?

May 2009 proposed guidance explains claims must be truthful, not misleading, fairly balanced and substantiated

Manner of presentation of risk and benefit determines net impression

FDA considers quantity, materiality and comprehensiveness of risk and benefit information

The format of risk and benefit information is important in determining net impression

Risk information and intended uses

• Endorsements must reflect the honest opinions, findings, beliefs, or experience of the endorser

• An endorsement may not convey any express or implied representation that would be deceptive (e.g. unsubstantiated claims) if made directly by the advertiser

• Testimonials must reflect typical experiences

• Material connections between the endorser and the seller must be fully disclosed

Some Basic FTC Rules

In Ohio, it is illegal to get a fish drunk.

Part Two: Guidance and Enforcement

The Ten Commandments contain 297 words. The Bill of Rights 463 words.

The Gettysburg Address 266 words. A federal directive to regulate the price of cabbage contains 26,911 words.

What are the issues for social media?

FDA Guidance

Topics for Discussion

FDA enforcement

Ihatepeas.com

The Law is not always clear

1. For what online communications are manufacturers accountable?

2. What parameters should apply to the posting of corrective information on sites controlled by third parties?

Permitted

Required

Questions that Arise with Social Media

''I have left orders to be awakened at any time in case of national emergency -- even if I'm in a Cabinet meeting.''

—President Ronald Reagan

You are responsible for:

1. Sites your firm owns or controls

2. Sites that someone else owns or controls, but you control or influence the content.

Does not include where the firm only provides financial support, e.g. through an unrestricted educational grant

“Influence” is quite controversial

FDA Draft Guidance: Responsibility for Content

The Government Doesn’t Always Get it Right

Two Different Concepts that FDA Sometimes Confuses

Intended Use Evidence

Labeling & Advertising

Scope Whatever shows the seller’s goal for the use of the product, e.g. oral statements of sales reps.

That which functionally accompanies the product to instruct and inform the user re the product, e.g. reprints

Require-ments

Must not suggest use beyond what is lawful

Many, including: • Truthful and not misleading • Fair balance • Adequate instructions for use • Name of manufacturer • Etc.

• “Influence” used in late 90s for CME guidance

Unrestricted educational grants

• Now used in social media to define scope of manufacturer labeling obligations

2014 Guidance on Postmarket Submissions of Interactive Promotional Media

• But guidance goes too far to include material that is not labeling, but may be evidence of intended use

“Influence” vs. Ownership/Control

Solicited Requests = requests for off-label information prompted in any way by a manufacturer or its representatives, for example:

Requests for users to post videos about their own uses of a product on third-party video-sharing sites

Tweets regarding an unapproved use (e.g., study results)

Providing off-label information to bloggers and consumer reviewers

Making standard responses to off-label requests available on-line

Solicited v. Unsolicited

2. What parameters should apply to the posting of corrective information on sites controlled by third parties?

Permitted

Required

Correcting Misinformation On Social Media Sites: Should ... · © 2015 EPSTEIN BECKER & GREEN,...

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