Importance of social media in Pharmaceutical industry

WHITE PAPER

Social Media and the Pharmaceuticals Industry

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Table of Contents

Growth of Social Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

What’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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Best Practice Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

About Actiance, Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8



©2001-2011 Actiance, Inc.


Growth of Social Networking

The statistics are mind-boggling. Let’s look at Facebook. Born on February 4, 2004, the site went from zero to 150 million users in the span of just five years. To give you some perspective, the humble telephone took 89 years, the television 38 years, and the mobile phone 14 years to reach the same level of saturation. Facebook now has over 500 million users, a veritable country (and a large one at that) unto itself. Similarly, Twitter grew 400 fold to 160 million 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 started out as a novelty has now evolved to an effective marketing vehicle. Companies use social media to promote their products, advertise promotional offers, and extend their brand reach. Similarly, companies use these sites to enhance customer 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 inevitably raise questions on several fronts, many of which still await resolution.





What’s Going On In the Pharmaceuticals Industry?

There are several drivers for the groundswell of calls for specific guidance on social media. Although the pharmaceuticals industry may be a bit behind, relative to other sectors, this doesn’t mean that the industry has been oblivious to the social media phenomenon. Already, we have begun to see an increasing number of companies using social networking sites for promotional purposes.

Guidelines for the pharmaceutical industry are lacking

Compared to other industries, the pharmaceuticals sector has been slow to promulgate guidelines with respect to 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 and ShareThis, 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.1 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.

The influence of social media as an effective promotional tool is unequivocal, especially when evaluated in the context of regulatory enforcement specific to social media. For instance, the financial services industry has already begun to see the Financial Industry Regulatory Authority (FINRA) doling out fines and suspensions for members that violate its social media guidelines. Guidelines were created initially to safeguard the interests of consumers and to better 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 this sector. 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 other power 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 Accountability Act (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 personal medical information becomes that much more challenging with each new site that emerges.

Maintenance of the status quo…for now

Until specific guidelines are disseminated, the pharmaceuticals industry will seemingly have to make do with what it’s got, i.e., the regulations that currently exist for print and broadcast media shall apply in the interim to social media activities. The process of formalizing guidelines for social media is likely to be a long one, but affected companies and interested parties have had and will continue to have ample opportunities to respond to draft documents, attend hearings, and help shape future regulations.

This process began in November 2009 when the FDA held a public hearing to solicit feedback and other pertinent information that would help the agency develop social media polices regarding the promotion of prescription drugs and medical devices.2 Over seventy presenters made their case to the FDA, essentially claiming that guidelines for social media were necessary and that both the industry and patients themselves were suffering from the lack of guidance.

1 “Compliance crack down on social media coming?” TheFinancialBrand.com, August 26, 2010.2 U.S. Food and Drug Administration website.





Patients are increasingly turning to social media sites for information on diseases, diagnoses, and treatments. At the same time, pharmaceutical companies want to provide patients with all the necessary and accurate information the latter needs to make important healthcare decisions. Yet, many pharmaceutical companies have refrained from participating in social media forums due to a lack of clarity on what they can do while still remaining compliant with existing FDA guidelines.3

Issues to ponder

Content controlThe explosive growth of social networking sites makes monitoring and policing incredibly difficult for the FDA. No industry wants to be held liable for content that it did not generate or condone. Specifically, companies do not want to 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 can influence or if it can control the medium through which the content is communicated. For instance, Google Sidewiki is a browser sidebar that allows the public to contribute and read information alongside any webpage without the website owner’s consent. This complicates the industry’s or an individual company’s ability to control the content being posted about it or its products. In other words, the tipping point is whether the company in question controls the medium in which the social media activity is taking place. Assuming a more prominent role (such as a host or sponsor of an event) may invoke a higher standard of responsibility than, say, being a mere participant in an event controlled by a third party.4

If a company is deemed to be in a position of control, then it is required to comply with applicable promotional regulations. This includes, among others, the following requirements:

•Communicationofapprovedindication(s)

•Appropriatebalanceofbenefitandriskinformation

• Informationthatistruthfulandnotmisleading

•Consistencywithapprovedlabeling

•Accesstoprescribinginformation5

Off-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 obtain FDA approval for the product to be so used. Given the proliferation of social networking sites, blogs, wikis, and the like, there is no shortage of avenues for information, whether correct or not, to be imputed to the pharmaceutical company.

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.





Form 2253 SubmissionsThe FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through FDA Form 2253. What exactly should fall within the scope of Form 2253? Static content only? Chat room transcripts? Both? This issue has many implications. Requiring every single communication, be it through a chat room, email, flyer, etc., may prove too onerous and overwhelming for regulators. There have been suggestions to impose some limits on the Form 2253 rule, such as the submission of only static elements of social media activity controlled by a company or promotional postings on social media sites controlled by third parties, should fall within the purview of Form 2253.6

Adverse 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 for information.7 It is a critical issue because a company could be required to monitor the whole Internet, including social media sites, to review adverse event information posted on such sites.

6 Davies, p. 5.7 U.S. Food and Drug Administration website.





Best Practice Recommendations

Developing a social media policy that is appropriate for your company is the most critical step in managing the use of these sites within the enterprise. A policy should be clearly drafted, including the acceptable uses of social networking sites and their associated technologies. Violations of these policies should be unequivocally spelled out as well, 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 kept informed of the latest version. Perhaps periodic all-hands emails or meetings would be an effective approach to keep everyone current.

Furthermore, enforcing the policy gives it credibility, essentially putting some “bite” behind the “bark.” If an employee breaches the policy, knowing that termination is the punishment, then the company should follow through and let the offending party go, lest the policy be rendered toothless. As long as the policy is fair and clearly communicated from the outset, then the company can confidently enforce the policy while operating within the confines of the law.

Until such time that the FDA officially announces guidelines for the use of social media tools by pharmaceuticals companies, the industry has to make do with existing regulations. Because there are so many potential pitfalls when leveraging social networking, it would behoove pharmaceutical companies to take notes from other industries that have already issued social media guidance.

Companies must be careful that damaging information not be imputed to them. Third-party content could include testimonials, articles, websites, videos, and research studies. Maintaining appropriate records is also advisable in 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.





About Actiance, Inc.

Actiance enables the safe and productive use of unified communications, collaboration, and Web 2.0, including blogs and social networking sites. Formerly FaceTime Communications, Actiance’s award-winning platforms are used by 9 of the top 10 US banks and more than 1,600 organizations globally for the security, management, and compliance of unified communications, Web 2.0, and social media channels. Actiance supports all leading social networks, unified communications providers, and IM platforms, including Facebook, LinkedIn, Twitter, AOL, Google, Yahoo!, Skype, Microsoft, IBM, and Cisco.

Socialite

Socialite is Actiance’s security, management, and compliance solution for Social Networks, providing granular control of Facebook, LinkedIn, and Twitter. Socialite not only controls access to 150 different features across social networks, but can also moderate, manage, and archive any social media traffic routed through the solution, which can either be on-premise or hosted.

Socialite includes a number of key features for securely enabling the use of social networks, including:

•Dataleakprevention: preventing sensitive data from leaving the company, either maliciously or inadvertently

• Identitymanagement: 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)

•Activitycontrol: managing access to features, such as who can read, like, comment upon, or access specific features

•Moderatorcontrol: pre-approving content for Facebook, LinkedIn, and Twitter, where content is required to be reviewed by a corporate communications officer or other third party

•Granularapplicationcontrol: enabling access to Facebook but not to Facebook Chat or downloading/installing any of the applications in the gaming category

•Conversationandcontentlogging: capturing all posts, messages, and commentary in context, including export to an archiving platform of your choice for eDiscovery purposes

About the Author

Norv Leong brings over ten years of marketing experience to his role at Actiance. He has worn hats spanning product marketing, product management, strategy consulting, and even the law – at companies both big (HP, NetApp) and small (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 Johns Hopkins University (M.A.). He is a licensed member of the California Bar.

Date post:	28-Nov-2014
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Importance of social media in Pharmaceutical industry

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