Todays’ post previously appeared in Pharmaceutical Compliance Monitor and is by Joanna Belbey, Social Media and Compliance Specialist, Actiance. Follow Joanna on Twitter @Belbey.
Social media and the pharmaceutical and biotechnology industries are not known to be comfortable bed fellows.
According to a report released by the IMS Institute for Healthcare Informatics, only half of the top 50 pharmaceutical companies worldwide actively participate in social media on Facebook, Twitter or YouTube. And only 10 of these companies utilize all three of these major social networking services for healthcare topics, and then mainly as a unilateral broadcasting channel to physicians and patients, rather than fostering interactions or discussions.
This however, looks set to change. After four years of deliberation, the Food and Drug Administration (FDA) has released much anticipated draft guidelines for the pharmaceuticals and biotech industry around the use of social media for marketing and promotional purposes (Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics). The FDA is widely expected to publish the finalized guidelines by July 2014.
Of note is the broad definition of ‘interactive promotional media’ mentioned in the draft guidelines. The FDA defines this medium as that which ‘allow(s) for real-time communications and interactions (e.g. blogs, microblogs, social networking sites, online communities, and live podcasts)’ that firms might use to promote themselves or their products.
The FDA draft guidelines include the proposed reporting obligations for member firms, with firms required to submit a copy of their first post on social media to the FDA. However, realizing that the real-time nature of social media communication makes the submission (and review) of every post impractical to both the firm and the regulator, the FDA will thereafter only require a monthly update with the names and URLs of the social networks used and the date of the firm’s most recent activity.
Another indication that the FDA has researched and analyzed how companies are using the medium, is that, it will be holding member firms accountable for its’ employees’ personal social media accounts if they are being used to promote the firm or the firm’s products.
Having established that the use of social media within the pharmaceutical and biotechnology industry is still in its infancy, what can firms learn from the social media experience of other companies, who also come from heavily regulated industries?
Three of the most common missteps are:
1) One Size Fits all Social Media Policy
While having a corporate social media policy is a key foundation and building block to establishing a credible social media presence, the policy itself will not protect the firm from falling foul of regulatory requirements or sanctions.
Social media is constantly changing – within the space of just a few months last year, Actiance’s Social Media Labs detected 10 major changes that have gone ‘live’ on the main social networks. Some of these changes could have significant impacts on the social media interactions of a firm. A social media policy that does not take a long-term view of social media or have the breadth or the depth to cover the changing social media landscape is only worth the paper it’s printed on. Constant review and revisiting is required, with a view to update both the policy and employees where necessary.
Pharmaceutical and biotechnology firms have different divisions, each of which might want to use social media for very different reasons. Sales and marketing, research and development, right to the top of the organization, to the office of the Chief Executive and Board of Directors all come to mind. A single, overarching corporate social media policy may not fit all. Multiple policies may be needed, to speak specifically to the needs of the different groups within an organization, and to provide the comprehensive guidance needed for compliant use of social media within an organization.
2) Not Planning for Record Keeping
As evidenced from the draft guidelines, the FDA has indicated that they will ‘exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions’. In a footnote, the FDA has also requested that ‘It is preferable for the firm to submit the interactive or real-time communications in an archivable format that allows FDA to view and interact with the submission in the same way as the end user (e.g., working links). Alternatively, firms should submit screen shots or other visual representations.
It is therefore essential for firms to institute good record keeping procedures that make it easy to record, archive and retrieve its social media communications on a regular basis. Not only will this be necessary for the monthly postmarketing submissions to the FDA, firms may also be called upon by the regulator to provide detailed information in the event of an enforcement spot check.
Third party technology providers are already helping firms in the banking and finance industries that also have record keeping requirements from regulators and legislators. These solutions streamline and automate the process of monitoring, archiving and retrieving social media interactions making it possible for firms to comply with the rules and regulations while benefiting from social media.
3) Ignoring Key Learnings from Other Industries and Countries
The finance and banking industry is worth studying – in 2010, the industry regulator issued its first set of social media guidance, FINRA Regulatory Notice 10-06 Guidance on Blogs and Social Media Networks. Since then, more iterations have followed, but social media adoption rates within the industry are high. A 2012 study by Accenture found that 60% of the financial advisers it surveyed had daily contact with clients through social media.
Pharmaceutical and biotechnology industry regulators from UK have already issued guidance for the use of social media. And there are examples of social media campaigns run across multiple social networks.
Learning from firms both within and outside of this industry, who have already ventured into the waters of social media, can provide insights and fast track the process of engagement.
Three missteps that are less common are:
1) Not Providing the Tools to Enable Employees to Engage Authentically on Social Media
One of the key elements of successful adoption of social media is training. Firms often educate their employees on what is not allowed and ignore the opportunity of teaching employees the nuances of using social media authentically, engagingly and effectively.
Not every employee within the firm approaches social media with the same level of skill or experience. This can potentially pose more problems for a firm than not having a detailed corporate social media policy.
This is illustrated in the case of a pharmaceutical company in the UK, who in 2011, was ruled in breach of the Association of the British Pharmaceutical Industry (ABPI) Code, for promotion of a prescription-only medicine to the public via Twitter. The firm tried to argue that the tweet in question had been posted by an ‘inexperienced’ Twitter user. However, the firm was ultimately held responsible by the ABPI for the Tweet and sanctioned.
2) Not Working out a Content Strategy
Social media interactions are by their very nature two-way, real-time conversations. The people who use social media are driven by the desire to seek out information and connections that are meaningful to themselves.
The success stories from within the pharmaceutical and biotechnology industry demonstrate that compelling content, such as lifestyle and health information, drives engagement from patients and physicians on social media.
Sharing drug release information on social media platforms should not be the main thrust of any firm’s social media initiative (and indeed, with the Federal Food, Drug, and Cosmetic Act requiring firms to state the name, quantitative ingredients, and clear and neutral information on side effects, contraindications and effectiveness of the drug every time a drug is mentioned, the character limitation of social media may present a challenge).
A solid content strategy that works out not only what to share but when to share and who is doing the sharing is a cornerstone to getting it right on social media. Under the draft FDA guidelines, personal accounts, i.e., employee accounts, fall under the same scrutiny when used to promote the firm. It is therefore crucial that firms provide employees with appropriate content that can be shared quickly and easily, while having peace of mind that they are doing so within the regulatory framework.
3) Sending All Posts to the FDA In Advance
The draft FDA guidelines make it clear that the FDA understands that the real-time nature of social media communication, makes it impractical and indeed, onerous, for firms to submit all its interactions for review before posting.
Aside from the first post, the FDA requires only the ‘postmarketing’ submissions on a monthly basis using an online form provided on the FDA website.
This clears the way for firms to use social media platforms as they are meant to be used – communicating with patients, physicians, and other stakeholders in real-time.
The finalized guidelines from the FDA are due in July 2014. So, now is the perfect time for firms to craft social media employee usage policies, select third party vendors for controls and recordkeeping and to develop content strategies to take advantage of social media to build positive relationships with patients, physicians and stakeholders.