life sciences companies and their social media usage

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Life Sciences & Social

Media

Impact of FDA Guidance


Why Life Sciences

Companies Should

Engage on Social Media

HIGHLIGHTS

In today's social media boom, the Life

Sciences industry has remained cautious

in its social endeavors, owing to lack of

clarity on guidelines, especially wrt

adverse event reporting.

In the view of the latest FDA guidelines, this white

paper aims to shed light on the realities of Adverse

Event Reporting in social media.


Shying Away from Social Media

Why are Life Sciences companies shying away from Social Media?

Considering the nature of social media Life Sciences companies are concerned about consumer discussions that would indicate an adverse experience.

What do the FDA guidelines say?

According to guidelines, when a Life Sciences company has knowledge of any adverse event , it has an obligation to file a report with the FDA through the Form 3500A-Mandatory Reporting.

What is an adverse event?

An adverse event (AE) is defined as any unfavorable and unintended sign including abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or

procedure, regardless of whether it is considered related to the medical treatment or procedure.


Key Findings of Wipro's Social Listening

Wipro used its Social Media Monitoring Platform to conduct an analysis of

2100 messages related to Pharma and Medical Device products posted

online across various internet forums.

The research revealed that for all posts containing mentions of the 13 brands

considered for this study:

Only 3% of all posts have mention of an Adverse Reaction

Only 0.38% messages actually qualify for an Adverse Event Reporting

The incidence of Adverse Events is almost same for Pharma Drugs and

Medical Devices

The messages with mention of Adverse Events are considerably less for

Medical Devices as compared to Pharma Drugs


FDA Guidance on AE Reporting

Are Life Sciences companies that are monitoring social media obligated to respond to any

unsolicited requests on consumer-generated media?

The FDA guidance does provide some insight into FDA’s stance on Social Media.

A Life Sciences company that aggressively monitors social media may pick up the

occasional AE within patient or physician online discussion.

However an instance qualifying for Adverse Event Reporting would be

encountered very rarely, with a volume that would be entirely manageable

within the company‘s broader AE monitoring programs.

The company has the choice to respond to unsolicited requests or not

If the company chooses to respond, the actual response can only be provided in a private, one-on-one communication


Benefits of Engaging on Social Media

Improved understanding of patient's concerns

Aversion of risk of unapproved usage

Better understanding of patients' experiences

Competitor analysis

Engagement with caregivers


Conclusion

The FDA guidance on the responsibilities of Life

Sciences companies monitoring the social

media comes as a sigh of relief.

The benefits of social listening far outweigh the

concerns that companies share.

The future of Life Sciences marketing is in being

part of conversations in the online space.


For more details please visit the link below:

http://www.wipro.com/Documents/why_life-

sciences_companies_should_engage_on_social_media.pdf

http://www.wipro.com/Documents/why_life-sciences_companies_should_engage_on_social_media.pdf




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