Correcting Misinformation On Social Media Sites: Should ... · © 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. EBGLAW.COM Correcting Misinformation On Social Media Sites:

© 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. EBGLAW.COM

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


Regulatory Framework

Guidance

Topics for Discussion

2

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

© 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. EBGLAW.COM © 2014 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com

Part One: Regulatory Framework

3


It’s good to know the basics

From SignSpotting by Lanksy

4


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

5


“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

6


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

7


Truth in Advertising

Funky.co.uk

8


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

9


Just Opinion?

10


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

11


• 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.

12


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.

13


What are the issues for social media?

FDA Guidance

Topics for Discussion

14

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

15

''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

16


The Government Doesn’t Always Get it Right

17


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.

18


• “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

19


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

20


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

Permitted

Required

More Questions

21


• A firm is responsible for communications that are owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm.

• Firms are generally not responsible for third-party UGC about their products when the UGC is truly independent of the firm … regardless of whether the firm owns or operates the platform on which the communication appears.

Correcting Third-Party Misinformation

22


• If a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum.

• A firm should

1. Clearly identify the misinformation it is correcting,

2. Define the portion of the forum it is correcting, and

3. Should correct all the misinformation that appears in that clearly defined portion.

Correcting a Clearly-Defined Portion of a Forum

23


I found no major public actions that reflect

the draft guidance on correcting information

Enforcement

24


Part Three: Case Studies

25


Company: Bonafide Medical

Product: PrickRight

FDA approved use: Blood glucose meter, with limits such as:

1. May be used only for patients whose hematocrit is between 20 percent and 65 percent

2. Has not been evaluated or cleared for use in critically ill patients

Common Facts

26


• An aging, celebrity rock star – Bad Thompson – posts on the Bonafide Medical Facebook page:

• “PrickRight is incredibly easy to use even for a dummy like me who is all thumbs.”

• After years and years of drug abuse and hard living, Bad is commonly known to be near death from cancer, HIV/AIDS and hepatitis.

• The company does nothing about the post.

• Is that okay?

Company Facebook Page

27


• Dr. Archibald Clairemont Whitebread, III, a preeminent endocrinologist in Boston, conducts clinical trials with the PrickRight.

• Bonafide Medical operates a very popular chat room accessible off the company’s home page that is open to doctors and scientists who register and get a password.

• The stated purpose of the chat room is to advance the science of blood glucose monitoring.

• Dr. Whitebread posts information on a clinical trial he is conducting, to the effect that the PrickRight loses much of its accuracy if the hematocrit is above 65%.

• Under the company’s terms of use which provide the company with authority to remove any off label content, the company removes the post.

• Is that okay?

Company Managed Scientific Chatroom

28


• A doctor named Wile E. Coyote tweets

• “PrickRight is amazingly accurate, far more so than any other meter I have used.”

• The company does nothing.

• Is that okay?

Tweet from a Doctor

29


• A young, vigorous athlete decides to create a video of using the PrickRight while riding his mountain bike down Bright Angel Trail in the Grand Canyon during a winter snow storm.

• With friends filming him, he rides his bike over boulders while he simultaneously, one-handed, pricks his finger and manages to use the PrickRight.

• Posts the video to a patient website www.Peoplewithdiabetes.com

• Bonafide Medical is a sponsor of the website.

• They do nothing.

• Is that okay?

Patient YouTube Video On A Support Group Site

30

http://www.peoplewithdiabetes.com/


Part Four: Brad’s Best Practices

31


• Make corporate decision regarding on which sites the company will actively participate

• For company controlled sites and those on which the company actively participates:

Monitor and, to the extent possible,

Correct inaccurate information

Delete off label information

Make sure you do not cherry pick

Evaluate potential adverse event information for possible follow up and reporting

Brad’s Guidance on Corrective Information

32


• Ensure all company generated material is fairly balanced and complies with traditional product promotion requirements

• Use the company’s approval process where possible

• Establish terms of use for company sponsored and controlled sites that prohibit product-specific discussions or limit discussions to on-label information

"I would have made a good Pope!" - Richard M. Nixon

Brad’s Guidance on Product Information

33


• Develop policies for employee use and official use of social media

Rules for anything on topic

Rules for consultants and others

• Train on those policies

• Be aware of NLRB decision on unduly restrictive social media policies/unfair labor practice

• Be transparent with respect to company sponsorship or involvement with contributors in social media and direct employees to do the same

Brad’s Guidance Re Employees

34


Questions?

Arguing with a lawyer is like mud wrestling with a pig: after a while you realize that the pig actually enjoys it.

Documents

Correcting Misinformation On Social Media Sites: Should ... · © 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. EBGLAW.COM Correcting Misinformation On Social Media Sites: