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Life Sciences & Social
Media
Impact of FDA Guidance
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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.
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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.
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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
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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
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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
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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.
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For more details please visit the link below:
http://www.wipro.com/Documents/why_life-
sciences_companies_should_engage_on_social_media.pdf
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Wipro set up the Council for Industry Research, comprised of domain
and technology experts from the organization, to address the needs of
customers. It specifically surveys innovative strategies that will help
customers gain competitive advantage in the market. The Council, in
collaboration with leading academic institutions and industry bodies,
studies market trends to help equip organizations with insights to
facilitate their IT and business strategies.
For more information on the Research Council visit
www.wipro.com/insights or mail [email protected]
About Wipro Council for Industry Research
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About Wipro Technologies
Wipro Technologies, the global IT business of Wipro
Limited (NYSE:WIT) is a leading Information
Technology, Consulting and Outsourcing company,
that delivers solutions to enable its clients do
business better. Wipro Technologies delivers winning
business outcomes through its deep industry
experience and a 360 degree view of “Business
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Thank You ©Wipro Limited, 2012. All rights reserved.
For more information visit www.wipro.com
No part of this document may be reproduced in
whole or in part without the written permission of the
authors.
Wipro is not liable for any business outcome based
on the views presented in this document. For specific
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