Thought Leadership/Life Sciences. Social Media Monitoring

Transcription

1 Social Media Monitoring

2 Thought Leadership/ Life Sciences Social Media Monitoring Overview Over the course of the last several years, the amount of user-generated content on the Internet has increased dramatically both in sheer quantity and in variety of available formats. Traditionally, material on the Internet was produced only by those entities with access to the necessary web design tools and services; thus, in general, only governments, media outlets, corporations, and a limited number of individuals with knowledge of web markup languages had the ability to publish their content to the Internet. Today, it is simple and common for individuals to post pictures or videos, product reviews, personal or political commentary, or any type of content to the Internet. This transition has been enabled by a number of new social media technologies and tools. Other social media technologies include virtual worlds (such as Second Life), product review websites (such as Yelp and Epinions), and event organization sites (such as Meetup). Collectively, these and other technologies have promoted and enabled what is popularly known as Web 2.0 that is, the phenomenon through which individual Internet users are able to publish and control their own content on the Internet. In recent years, there has been an explosion in the use of these Web 2.0 technologies; while most of these websites did not exist 10 years ago, today roughly 60 percent of Americans engage in social media platforms, including sites such as Facebook, LinkedIn, YouTube, and Twitter. 1 Social media outlets present the opportunity to express thoughts, ideas, and opinions; this opportunity is offered not just to individuals, but also to corporations. The presence of social media is visible in nearly every industry; public and private sector organizations alike commonly embrace and leverage at least one of many social media tools via blogs, twitter, podcasts, video sharing, or other means. Some examples of companies using social media sites to communicate with consumers include: A big three automaker made a public plea for support of the automotive industry bailout via a campaign on YouTube. Over 20,000 companies maintain Facebook pages, including prestigious Fortune 500 companies; through these pages, they can distribute promotional information or interact with other users. 2 Companies may also allow other users to become their fans or to post messages on their wall. Companies distribute product updates via blogs, while other companies maintain blogs which relate thoughts about larger industry trends and social responsibility issues. Major airlines distribute fare specials and other promotional information to their followers in short bursts via Twitter. 1 Cone; Cone Finds That Americans Expect Companies to Have a Presence in Social Media, Sept key Social media technology and tools Blogs and General Websites: Sites which enable corporations and/or individuals to post commentary, pictures, or videos at a static web address that may be distributed to and viewed by many different Internet users. This content is generally updated regularly and often focuses on a single industry, interest, or other theme. Photo and Video Sharing: Sites such as Flickr, Picasa, or YouTube, which enable users to post pictures and other types of media in a public setting. Media posted to these sites may be tagged with information about their theme, content, or other information. Podcasts: Podcasts are similar to blogs in that they are often a user s commentary on a particular subject, however they are distributed in audio rather than written format. End users may load these podcasts onto their phones or other MP3-playing devices, or they may be played and listened to on a computer at the time of download. Social Networking Sites: Examples include LinkedIn and Facebook; these sites enable individuals to connect to and communicate with other individuals based on shared interests, friendship, or employment. In some cases, users may create personalized profile pages and may post content to their own or other users profiles. Twitter: A site which enables users to distribute tweets to a large number of individuals at one time. These tweets can be thought of as a micro-blog in that they contain user-generated content, often centered on one theme or area of interest, but their size is limited to 140 characters. End users may receive tweets via text message, computer, or other means. Wikis: Websites such as Wikipedia which contain dynamic articles on a variety of subject areas edited by multiple individuals. Most wikis are not generally maintained or reviewed by any one dedicated source, and thus their content may ultimately become misleading or untrue if edited by individuals with differing viewpoints on a given matter. 1

3 Overall, countless corporations have engaged with consumers via social media websites, and these interactions appear to be welcomed; indeed, of the participating social media population, 85 percent believe that companies should actively communicate with their clients via social media. 32 Applications within the Biotechnology, Medical Device, and Pharmaceutical Industries To date, many different companies within the biotechnology, medical device, and pharmaceutical industries have established a formal presence on various social media websites. These sites have been used to communicate information about new products, opinions on various government initiatives, or general disease state information. For example: Twitter is used by at least a dozen high profile biotech, device, and pharmaceutical companies to disseminate clinical trial, disease state awareness, event sponsorship, and other industry or general information. Several companies maintain a blog on which company representatives discuss financial results, industry information, and promote disease state awareness. The FDA itself utilized a variety of social media including a blog, Twitter, podcasts, and even ecards to disseminate information about the recent peanut-product recall. 43 In general, Web 2.0 social media technologies offer life sciences companies new and innovative methods to promote their products and interact with consumers. For instance, a medical device company might create a YouTube page on which it could load videos about its customers before-and-after experiences (subject, of course, to all FDA promotional regulations); a pharmaceutical company might develop a twitter campaign to alert interested consumers to new developments in research, or start a campaign on Facebook to encourage a patient population to closely follow the drug regimen prescribed by their doctors; a biotechnology company might produce a Wiki page on which its research and development scientists could post information regarding the latest advances in research. Aside from simply pushing out content, companies may also choose to utilize Web 2.0 technologies to foster greater interaction with their customers. A company could choose to ask consumers to submit photos that demonstrate how one of the company s products has improved that individual s life; these photos could then be compiled in a Flickr gallery. Alternatively, companies may use the direct message feature on Twitter or messaging capability on Facebook to communicate directly with consumers who may submit questions, comments, or concerns about a company or its products. In the case of Facebook, companies 3 Cone; Cone Finds That Americans Expect Companies to Have a Presence in Social Media, Sept may even allow members to become fans of their company or one of their products in order to foster brand loyalty and awareness. While Web 2.0 offers many opportunities for life sciences companies to improve their relationships with consumers, the companies must act in accordance with all FDA, FTC, and other relevant guidelines in order to ensure that any communications or other promotional messages are in compliance with state and federal legislation. The Current Regulatory Environment In 2009, FDA warned 14 major pharmaceutical firms about brief Internet advertisements that could have misled patients because they did not include information about health risks related to the drugs. However, to date the FDA has issued no specific guidance regarding biotechnology, medical device, and pharmaceutical company usage of social media technologies. A recent public hearing on this matter was held in Washington, DC on November 12-13, At this hearing, representatives from pharmaceutical, biotechnology, and medical device companies, along with patients, concerned citizens, and representatives from industry trade groups, periodicals, and social media sites, discussed their usage of and concerns related to social media sites. Primary concerns and suggestions included: Social media sites have a wealth of information related to medical conditions and treatments, but it is difficult for consumers to determine what information is reliable and what may be untrue. Participants suggested that the FDA establish a review process for medical information on social media websites; all information which met FDA standards and was approved would be accompanied by a specially-designated logo to indicate to consumers that the content was reliable. The adverse event reporting process should be simplified, and an adverse event reporting widget which could be embedded into social media sites should be created. This widget would facilitate the accurate and complete reporting of adverse events; adverse event information currently provided via social media websites is generally not comprehensive enough to generate an adverse event report. Due to their quantity and their nature, Tweets are currently very difficult to track. A dedicated hash tag should be created for each product, and Twitter users would be required to embed that hash tag in each Tweet related to the relevant product. This would facilitate more efficient monitoring of product-specific tweets. In general, participants agreed that increased guidance from the FDA was necessary; however, concrete guidance on this matter will undoubtedly not follow for months or years after this public hearing. Until the FDA has issued formal guidance, companies would be prudent to exercise the same level of caution in all content they publish via social media sites as they would with content published via traditional means. 2

4 Establishing a Control System for Company-Initiated Social Media Content Web 2.0 presents many opportunities for corporations to actively communicate with consumers or other individuals via social networking sites. For instance, a representative on Twitter from the largest healthcare products company actively communicates back and forth with other Twitter users on questions related to corporate issues, disease state awareness, social responsibility, and other topics. Via Facebook, corporate representatives in a variety of industries routinely communicate with consumers on matters related to new products, customer service, or other issues. Life sciences companies may wish to engage in developing social media content in order to garner greater patient collaboration, promote brand awareness among an informed audience, and provide a forum to further measure consumer attitudes and behaviors. Without engaging in open dialogue with the community, companies may risk the loss of public credibility, particularly in the face of competitors who have a coordinated focus with consumers on the Web. Although social media technology may offer the possibility of many benefits, the regulatory environment in which life sciences companies operate mandates that executives address serious concerns and challenges involved with social media. In order to mitigate the risks associated with undertaking such an initiative, a company must first understand exactly what types of media are being produced (e.g., pictures, videos, tweets, etc.), what type of information is being discussed in each of these types, and who is producing the information (e.g., employees, patients, consultants, etc.). Companies should then identify, in light of FDA/FTC regulations and guidance, the specific liabilities associated with each type of content. In order to protect the image and best interests of the company when facing these risks, each company should consider proactively creating a common companywide policy surrounding the internal use of social media technology. Clear written guidelines must be developed which should consider the points provided to the right. By developing a comprehensive set of policies and procedures related to company-initiated social media content, companies will be able to better control risk that might result from promotional activities through these media. guideline Considerations for the internal use of social media 1. Institute a committee which will review all materials to be posted on social media websites; this committee would likely consist of the same or similar people who currently make up the company s Promotional Review Committee (or equivalent). 2 Establish a dedicated review and approval process for all materials which would be posted to social media sites. Similar to the consideration above, this process would likely be the same or similar to the company s existing promotional material review process. All materials would need to be routed through this process and the committee proposed in the above consideration point prior to being posted on any social media sites. 3. develop clear and consistent guidelines which would be used to evaluate proposed social media pieces prior to their distribution. These guidelines should tie closely to any guidance provided by the FDA; in the period of time prior to the provision of that guidance, these guidelines should generally adhere to the company s existing policies related to the publication of promotional materials. 4. Ensure that, where applicable, information is posted to social media sites in a manner such that it is not readily accessible to residents of those countries in which it would be illegal to transmit such information. For instance, information which might be considered direct-to-consumer advertising should not be posted to the local country versions or in the local country languages of social media sites where the local country regulations do not allow for the production of direct-to-consumer advertising. 5. Companies should consider instituting the position of Social Media Monitor ; the person in this position would be the centralized clearinghouse for all social media postings and would be responsible for maintaining all social media accounts. New accounts could not be created without permission from the Social Media Czar. This position would likely reside within the company s Compliance department. 6. Finally, companies should consider developing enterprise-wide training to educate employees on these new policies and instruct them that they must not use personal Twitter, Facebook, or other social media accounts to disseminate confidential company information 3

5 Establishing a Monitoring System for non-company-initiated Social Media Content The very nature of social media websites exposes companies to reputational risks that they cannot easily control. Consumers may post unfavorable reviews on sites such as Yelp, Epinions, or their own personal blogs; while these reviews may reach a relatively narrow audience, viral videos can rapidly reach a very large population of potential consumers. Whether or not any particular life sciences company chooses to actively engage in social media, there are a number of web users already participating in public forums linked to personal health, prescriptions, and these industries. For example, recent statistics show that nearly 300 Twitter users identified an association to the pharmaceutical industry. 54 Via blogs, Twitter, Facebook, or many other methods, individuals may publish information related to company products, for instance: A physician may recommend a particular drug for an off-label usage on his or her blog A consumer may detail an adverse event resulting from his or her usage of a drug or device via his or her Twitter account A competitor may intentionally publish misinformation on a Wikipedia entry in an attempt to discredit the company in the public s eye In a particularly dangerous scenario, a company employee may disseminate confidential information not appropriate for public knowledge via his or her blog In the life sciences industries, the potential for risk extends far beyond mere reputation damage. The publication of off-label information or information not approved for dissemination in a particular country could expose a company to significant compliance risk, if it becomes apparent that the company either explicitly or implicitly condoned the posting of this information. This risk could be particularly salient in those cases where companies openly encourage the creation of user-generated content, or if a company allows posts or comments to be made to its Facebook account, blog, or other sites. However, if manufacturers provide significant support for user-generated content, consideration must be given to the impact on the learned intermediary doctrine and the effect that support may have on potentially substituting for doctorpatient interactions. In order to control risk from non-company initiated social media content, life sciences companies should consider taking the following actions: 1. Ensure that any posts made to a company s Facebook or Flickr account, Blog, or other social media site are published to the web only after being reviewed through the same process outline as company-initiated social media content. This will help mitigate the risk that off-label information or information contrary to Federal Drug Administration (FDA) or Federal Trade Commission (FTC) guidelines is not published on sites that are sponsored, managed, or maintained by the company. Alternatively, companies may simply choose to prohibit the addition of user-generated content to social media sites which are officially sanctioned by the company. 2. determine whether or not content on sites which are not officially sanctioned by the company must also be monitored for compliance with FDA and FTC regulations related to off-label promotion, adverse event reporting, presentation of risk information, and other guidelines. 3. determine whether or not social media sites must be monitored for the dissemination of confidential or unauthorized information by company personnel including violations of patient privacy (impact can vary by state and country). If a company determines that it must monitor social media sites for the posting of information about company products, or the unauthorized posting of information by company personnel, companies could potentially be faced with the impractical task of continually reviewing a broad array of social media sites. In this instance, companies should consider developing and implementing a monitoring portal as discussed in the following section. 5 Oct

6 Development of a Monitoring Program and Action Plan If a company determines that it has an obligation or need to monitor external social media sites for off-label usage claims, potential adverse event reporting, the disclosure of unauthorized information, or other areas of risk, the company will face a nearly limitless amount of data and information, which it will then have to analyze and review. To this end, companies may wish to implement a strategy based in informatics through the use of data-mining and text analytics. The use of an informatics-based solution allows companies to sweep the majority of web content through the use of tools such as web crawlers and return relevant posts based on business rules specified by the company. These business rules may instruct the data-mining tool to return only posts that: Are from a certain date range Are in a certain language Relate to or mention a certain product or disease state Relate to or mention keywords related to an off-label usage or adverse event for a certain product A variety of other factors As illustrated in the following diagram, company resources would then be responsible for reviewing the results and determining the appropriate action. Conclusion: Risks and Opportunities Web 2.0 and the associated explosion of user-generated content on the Internet present a variety of opportunities and risks for life sciences companies. These new methods for distributing information allow companies to educate the public, connect with consumers in the most up-to-date manner, and distribute promotional and disease-state information in real-time. With these opportunities come new risks: companies must continually be vigilant for the posting of unauthorized material, material which has not been properly reviewed through the company s social media material review process, or material that could be considered off-label promotion or potentially requiring adverse event reporting. Companies must also address the potential volume of information shared on various social media sites with the ability to process that information in a continuous and timely manner for state, federal, and international regulatory compliance purposes. Ultimately, these risks must not be viewed as simply compliance risks, but also as business risks as content posted by dissatisfied customers may reach millions of additional potential customers and sway their opinion of a company or product. Indeed, a search on Twitter for popular drug brand names will reveal posts from many users, many of which contain adverse event information related to usage of that drug. The industry as a whole must consider how to respond to such information so that their reputations are not themselves adversely affected. Data Advanced Analytics Business Rules Structured/Unstructured Text Mining/Scorecard Decision Management } Keyword Analysis Reports Suspicious phrases Acronyms Abbreviation handling }Historical violations Escalation Website Content } Website Requests Disease Magagement Data Company Social Media Alerts Business Rules Service Business Rules, Trees, Models 5

7 About Huron Huron s Life Sciences Advisory Practice assists biotechnology, medical device, and pharmaceutical firms with addressing compliance and business challenges associated with the use of social media. We have developed processes and tools to help companies evaluate and mitigate the compliance and business risks in using social media, as well as informatics solutions to monitor and assess user-generated and company content, for a full picture of your firm s online presence. To discuss social media, please contact any of our Life Sciences Advisory Professionals. Mark DeWyngaert mdewyngaert@huronconsultinggroup.com Debjit Ghosh dghosh@huronconsultinggroup.com Paul Silver psilver@huronconsultinggroup.com Manny Tzavlakis mtzavlakis@huronconsultinggroup.com About the Author Dr. DeWyngaert provides operational, clinical, managerial, consulting, and litigation services to various segments of the life sciences and healthcare industries. Mark trained as a molecular biologist and has been actively involved in both research and business development roles for the past 25 years. He specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property. Mark regularly leads teams in the assessment of medical affairs and clinical development activities and assists companies in the redesign of business practices to comply with applicable regulations and standards. He is also experienced serving clients and their legal counsel in fraud investigations, compliance inquiries, litigation strategy issues, and acting as an expert witness. Dr. DeWyngaert is a frequent speaker on the management of regulatory risk associated with promotional education, research and clinical development activities, as well as in valuation practices and intellectual property matters. For more information, please contact Mark DeWyngaert at mdewyngaert@huronconsultinggroup.com 6

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