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Importance of social media in Pharmaceutical industry
 

Importance of social media in Pharmaceutical industry

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Guidelines for the pharmaceutical industry are lacking, Novartis had used Facebook and two popular social networking sites, to influence consumers in spreading the word about Tasigna, a cancer drug. ...

Guidelines for the pharmaceutical industry are lacking, Novartis had used Facebook and two popular social networking sites, to influence consumers in spreading the word about Tasigna, a cancer drug. The FDA concluded that Novartis’ act failed to meet regulatory and compliance standards. Specifically, the FDA called out Novartis’ marketing as incomplete and misleading since it failed to communicate any risk information associated with the use of Tasigna.

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    Importance of social media in Pharmaceutical industry Importance of social media in Pharmaceutical industry Document Transcript

    • WHITE PAPER Social Media and the Pharmaceuticals Industry
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 2Table of ContentsGrowth of Social Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3What’s Going On In the Pharmaceuticals Industry?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Guidelines for the pharmaceutical industry are lacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Maintenance of the status quo…for now . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Issues to ponder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Best Practice Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7About Actiance, Inc... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8This white paper is for informational purposes only. Actiance makes no warranties, express or implied, in this document.Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights under copyright, no part of this document may be reproduced, stored in orintroduced into a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the expresswritten permission of Actiance, Inc. © 2001 - 2011 Actiance, Inc. All rights reserved. Actiance and the Actiance logo are registered trademarks of Actiance, Inc. Actiance Vantage,Unified Security Gateway, Socialite, and Insight are trademarks of Actiance, Inc. All other trademarks are the property of their respective owners.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc. A-WP-008-SM-PHARMACEUTICALS-INDUSTRY-0111
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 3Growth of Social NetworkingThe statistics are mind-boggling. Let’s look at Facebook. Born on February 4, 2004, the site went from zero to 150million users in the span of just five years. To give you some perspective, the humble telephone took 89 years, thetelevision 38 years, and the mobile phone 14 years to reach the same level of saturation. Facebook now has over500 million users, a veritable country (and a large one at that) unto itself. Similarly, Twitter grew 400 fold to 160million users in the span of a year and a half. And LinkedIn adds a new member every second.These social networking sites have sprung up and proliferated within the corporate setting as well. What startedout as a novelty has now evolved to an effective marketing vehicle. Companies use social media to promote theirproducts, advertise promotional offers, and extend their brand reach. Similarly, companies use these sites to enhancecustomer relations, be it through conducting market research or soliciting feedback on current and future products.The openness of these social media tools, the relationships they foster, and the opportunities they present inevitablyraise questions on several fronts, many of which still await resolution.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc.
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 4What’s Going On In the Pharmaceuticals Industry?There are several drivers for the groundswell of calls for specific guidance on social media. Although thepharmaceuticals industry may be a bit behind, relative to other sectors, this doesn’t mean that the industry has beenoblivious to the social media phenomenon. Already, we have begun to see an increasing number of companies usingsocial networking sites for promotional purposes.Guidelines for the pharmaceutical industry are lackingCompared to other industries, the pharmaceuticals sector has been slow to promulgate guidelines with respectto social media. But, recent cases have begun to stoke the flames that guidelines are imminent and necessary.The recent case of the FDA cracking down on Novartis is a perfect illustration. Novartis had used Facebook andShareThis, two popular social networking sites, to influence consumers in spreading the word about Tasigna, a cancerdrug. The FDA concluded that Novartis’ act failed to meet regulatory and compliance standards.1 Specifically, theFDA called out Novartis’ marketing as incomplete and misleading since it failed to communicate any risk informationassociated with the use of Tasigna.The influence of social media as an effective promotional tool is unequivocal, especially when evaluated in thecontext of regulatory enforcement specific to social media. For instance, the financial services industry has alreadybegun to see the Financial Industry Regulatory Authority (FINRA) doling out fines and suspensions for members thatviolate its social media guidelines. Guidelines were created initially to safeguard the interests of consumers and tobetter regulate the registered representatives that constitute the heart of the financial services industry.The energy and utilities industry also has its own regulatory bodies that oversee companies doing business in thissector. The Federal Energy Regulatory Commission (FERC) and the North American Electric Reliability Corporation(NERC) are two organizations that aim to provide guidance to the electric companies, natural gas providers, and otherpower system operators with respect to the use of social media tools in marketing campaigns.Healthcare is another sector where regulation plays a major role. The Health Insurance Portability and AccountabilityAct (HIPAA) is the key legislation that requires the protection of patient identities and personal health information.Given the proliferation of personal data floating around the social networking landscape, the safeguarding of personalmedical information becomes that much more challenging with each new site that emerges.Maintenance of the status quo…for nowUntil specific guidelines are disseminated, the pharmaceuticals industry will seemingly have to make do with what it’sgot, i.e., the regulations that currently exist for print and broadcast media shall apply in the interim to social mediaactivities. The process of formalizing guidelines for social media is likely to be a long one, but affected companiesand interested parties have had and will continue to have ample opportunities to respond to draft documents, attendhearings, and help shape future regulations.This process began in November 2009 when the FDA held a public hearing to solicit feedback and other pertinentinformation that would help the agency develop social media polices regarding the promotion of prescription drugsand medical devices.2 Over seventy presenters made their case to the FDA, essentially claiming that guidelines forsocial media were necessary and that both the industry and patients themselves were suffering from the lack ofguidance.1 “Compliance crack down on social media coming?” TheFinancialBrand.com, August 26, 2010.2 U.S. Food and Drug Administration website.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc.
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 5Patients are increasingly turning to social media sites for information on diseases, diagnoses, and treatments. Atthe same time, pharmaceutical companies want to provide patients with all the necessary and accurate informationthe latter needs to make important healthcare decisions. Yet, many pharmaceutical companies have refrained fromparticipating in social media forums due to a lack of clarity on what they can do while still remaining compliant withexisting FDA guidelines.3Issues to ponderContent controlThe explosive growth of social networking sites makes monitoring and policing incredibly difficult for the FDA. Noindustry wants to be held liable for content that it did not generate or condone. Specifically, companies do not wantto be held accountable for social media activities without their permission or knowledge.The pharmaceuticals industry, however, also understands that it may be held liable for some content that it caninfluence or if it can control the medium through which the content is communicated. For instance, Google Sidewikiis a browser sidebar that allows the public to contribute and read information alongside any webpage without thewebsite owner’s consent. This complicates the industry’s or an individual company’s ability to control the contentbeing posted about it or its products. In other words, the tipping point is whether the company in question controlsthe medium in which the social media activity is taking place. Assuming a more prominent role (such as a host orsponsor of an event) may invoke a higher standard of responsibility than, say, being a mere participant in an eventcontrolled by a third party.4If a company is deemed to be in a position of control, then it is required to comply with applicable promotionalregulations. This includes, among others, the following requirements:• Communication of approved indication(s)• Appropriate balance of benefit and risk information• Information that is truthful and not misleading• Consistency with approved labeling• Access to prescribing information5Off-Label ClaimsPharmaceutical companies are constantly wary of being charged with promoting products for unapproved (“off-label”)uses. The FDA requires that companies provide either adequate labeling (e.g., a warning or precaution) or obtainFDA approval for the product to be so used. Given the proliferation of social networking sites, blogs, wikis, and thelike, there is no shortage of avenues for information, whether correct or not, to be imputed to the pharmaceuticalcompany.3 Sharp, Michele, “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools,” Eli Lilly and Company, November 12-13, 2009.4 Davies, Colleen T., et al., “Social Media in Action in FDA-Regulated Industry,” Legal Bytes (March 8, 2010), p.4.5 Social Media Working Group, “Pharmaceutical Industry Approaches for Engagement in Online Communities,” Nov. 12, 2009, p. 9.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc.
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 6Form 2253 SubmissionsThe FDA requires all prescription drug labeling and advertising to be submitted at the time of initial disseminationthrough FDA Form 2253. What exactly should fall within the scope of Form 2253? Static content only? Chat roomtranscripts? Both? This issue has many implications. Requiring every single communication, be it through a chatroom, email, flyer, etc., may prove too onerous and overwhelming for regulators. There have been suggestions toimpose some limits on the Form 2253 rule, such as the submission of only static elements of social media activitycontrolled by a company or promotional postings on social media sites controlled by third parties, should fall withinthe purview of Form 2253.6Adverse Event Reporting SystemThe FDA uses this system for investigating new safety concerns that might be related to a marketed product,evaluating a manufacturer’s compliance with reporting regulations, and responding to outside requests forinformation.7 It is a critical issue because a company could be required to monitor the whole Internet, including socialmedia sites, to review adverse event information posted on such sites.6 Davies, p. 5.7 U.S. Food and Drug Administration website.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc.
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 7Best Practice RecommendationsDeveloping a social media policy that is appropriate for your company is the most critical step in managing theuse of these sites within the enterprise. A policy should be clearly drafted, including the acceptable uses of socialnetworking sites and their associated technologies. Violations of these policies should be unequivocally spelled out aswell, so that employees are aware of the ramifications of breaches of the policy.Of course, disseminating the policy within your company is arguably as crucial as the creation of the policy itself.What good is the policy if no one knows about it? Hence, it’s imperative that your employees are sufficiently keptinformed of the latest version. Perhaps periodic all-hands emails or meetings would be an effective approach to keepeveryone current.Furthermore, enforcing the policy gives it credibility, essentially putting some “bite” behind the “bark.” If anemployee breaches the policy, knowing that termination is the punishment, then the company should follow throughand let the offending party go, lest the policy be rendered toothless. As long as the policy is fair and clearlycommunicated from the outset, then the company can confidently enforce the policy while operating within theconfines of the law.Until such time that the FDA officially announces guidelines for the use of social media tools by pharmaceuticalscompanies, the industry has to make do with existing regulations. Because there are so many potential pitfalls whenleveraging social networking, it would behoove pharmaceutical companies to take notes from other industries thathave already issued social media guidance.Companies must be careful that damaging information not be imputed to them. Third-party content could includetestimonials, articles, websites, videos, and research studies. Maintaining appropriate records is also advisablein order to back up any claims a company may have made regarding its product. At the end of the day, however,prudence and common sense should dictate any social media activities in the interim.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc.
    • WHITE PAPER – Social Media and the Pharmaceuticals Industry 8About Actiance, Inc.Actiance enables the safe and productive use of unified communications, collaboration, and Web 2.0, including blogsand social networking sites. Formerly FaceTime Communications, Actiance’s award-winning platforms are used by 9of the top 10 US banks and more than 1,600 organizations globally for the security, management, and compliance ofunified communications, Web 2.0, and social media channels. Actiance supports all leading social networks, unifiedcommunications providers, and IM platforms, including Facebook, LinkedIn, Twitter, AOL, Google, Yahoo!, Skype,Microsoft, IBM, and Cisco.SocialiteSocialite is Actiance’s security, management, and compliance solution for Social Networks, providing granularcontrol of Facebook, LinkedIn, and Twitter. Socialite not only controls access to 150 different features across socialnetworks, but can also moderate, manage, and archive any social media traffic routed through the solution, whichcan either be on-premise or hosted.Socialite includes a number of key features for securely enabling the use of social networks, including:• Data leak prevention: preventing sensitive data from leaving the company, either maliciously or inadvertently• Identity management: establishing a single corporate identity and tracking users across multiple social media platforms (e.g., @JohnJones on Twitter is the same as JohnHJones on LinkedIn)• Activity control: managing access to features, such as who can read, like, comment upon, or access specific features• Moderator control: pre-approving content for Facebook, LinkedIn, and Twitter, where content is required to be reviewed by a corporate communications officer or other third party• Granular application control: enabling access to Facebook but not to Facebook Chat or downloading/installing any of the applications in the gaming category• Conversation and content logging: capturing all posts, messages, and commentary in context, including export to an archiving platform of your choice for eDiscovery purposesAbout the AuthorNorv Leong brings over ten years of marketing experience to his role at Actiance. He has worn hats spanning productmarketing, product management, strategy consulting, and even the law – at companies both big (HP, NetApp) andsmall (Taalee, Internet Research Group). His areas of specialization include infrastructure and security software.He holds degrees from the University of California at Berkeley (B.A.), the University of San Diego (J.D.), and JohnsHopkins University (M.A.). He is a licensed member of the California Bar.Worldwide Headquarters EMEA Headquarters1301 Shoreway, Suite 275 400 Thames Valley ParkBelmont, CA 94002 USA Reading, Berkshire, RG6 1PT UK(650) 631-6300 phone +44 (0) 118 963 7469 phoneinfo@actiance.com emea@actiance.com©2001-2011 Actiance, Inc.