Everything You Always Wanted to Know about Government Regulators and Social Media Guidelines… But were Afraid to Ask

User research informs education website

Regulatory authorities have been working on social media guidelines for drug and device marketers for some time. These were due to be delivered at various times, most recently, by the end of the first quarter of 2011. Yet here we are, entering a new year, and the reality is that we may never receive explicit guidance from regulatory authorities on the use of social media.

To be fair, the rapidly shifting social media landscape makes it difficult – if not impossible – for regulatory bodies to produce meaningful guidelines that have any shelf life at all. Yet we are not flying entirely blind. While it is impossible to cover every situation and scenario in the incredibly dynamic space that IS social media, the aim of this article is to provide a sense of the types of questions pharmaceutical executives should be asking about what can and cannot be done with social media.

Social Media Defined

Step 1 is to agree on a definition for ‘social media.’ This is not easy because nearly everyone has an opinion about what the term means. The precise definition of ‘social media’ is not critical, but the key concept to bear in mind is this: ‘Social media’ does not refer to any individual site, such as Facebook or Twitter. Rather, it refers to any online media outlet, application or tool that allows people to collaborate and share information. Importantly, regulators have embraced this wider view of social media.

In general, social media sites encourage people to upload a profile containing information about themselves and allow users to share that information online with others. Social media encompasses a wide range of categories, including but not limited to, the following:

  • Social Networking – e.g., Facebook, Twitter, Badoo, QQ, LinkedIn
  • Social Bookmarking Sites – e.g., Delicious, Stumbleupon
  • Social News Sites – e.g., Digg, Reddit
  • Community Forums – e.g., CafePharma, qsrhelp.com, MDTF
  • Social Wikis – e.g., Wikipedia, Intellipedia
  • Blogging Sites – e.g., Blogspot, Blogster


Regulators care about what is being shared and where it can go once it leaves the creator’s fingertips. It’s about what you post AND where it ends up, geographically or demographically.

Why Social Media?

‘There are lies, damned lies and statistics.’

This quote is appropriate in this context for two reasons:

1)      Because of the nature of social media, the instant a statistic becomes available, it is out of date

2)      Both sides of a pro v. con debate on social media can use the same statistics to support their position.

However, it is worth highlighting a few ‘macro’ figures:

  • An estimated 650 million people participate in social media today1
  • 93% of business-to-business companies, including pharmaceutical and medical device manufacturers, are conducting social media programmes2
  • 57% of B2B executives think social media are ‘irrelevant’ to their business2
  • 75% of B2B executives don’t know how to measure return on investment for their social media spend2

The key takeaways from these figures are:

  • Lots of people are using social media… and lots more will be using them in the future
  • While people at most companies are engaged with social media, they are doing so ‘under the radar,’ without the knowledge of the proper authorities. Or… Individuals are doing things in this space just to do things, without measurable goals.
  • Finally, we need help figuring out what’s working and what’s not, and how effective our social media investments are.

Point 2 is particularly critical in the eyes of regulatory bodies around the world. Having the proper controls in place is critical to being able to respond to regulators’ questions about an organization’s use of social media.

It is estimated that the pharmaceutical industry spends approximately 4 per cent of its $5 billion direct-to-consumer (DTC) advertising budget on social media activities, and this percentage is increasing. Funds are rapidly being siphoned out of traditional media and into online and social media, where growth rates exceed 10 per cent per annum. 3

Note that the figures above do not include ‘educational’ activities related to conditions and therapy options. These approaches can be used virtually anywhere in the world and are designed to drive people to manufacturers’ online assets – Web sites, Twitter feeds or Facebook pages. It is virtually impossible to find a verifiable figure for this type of activity, but a compilation of estimates indicates that the total amount spent on online efforts add up to something like a hundred-fold multiple of what’s spent on traditional, product-focused promotional ad spending.

These statistics point to a huge potential risk, as well as a tremendous opportunity.

On the ROI side, current estimates suggest that companies view 25 per cent to 30 per cent of their online spending as ‘wasted.’ So, by simply implementing more effective campaigns, we will be that much further ahead than we are today! On the risk side, by avoiding fines, companies can focus on making every dollar, pound, euro, yen, yuan and rupee work to advance their business goals.

For example, a large global pharmaceutical company was fined $450 million for what the US Department of Justice (DOJ) called ‘lack of institutional control’ of a social media program. Note that the DOJ did not highlight actual violations such as off-label promotion; it penalized the company for not forcing proper procedures aggressively enough throughout the entire organization, including to individual sales reps.

What Do Regulators Think?

As noted previously, regulatory bodies are interested in what is posted AND where it ultimately ends up. That’s why having the proper controls in place is vital to any social media programme… And, while virtually every company thinks it has proper Digital Governance for its activities, very few truly do.

The most explicit and specific statement we have comes from the US Food and Drug Administration:

‘We believe it is a good idea for companies to have a robust policy in place for any type of promotion about their products, including social media promotion. We would advise them to carefully review their materials and processes to ensure that their promotion is compliant with the regulations. Consumers and healthcare professionals deserve an accurate and balanced picture of a product when it is promoted.’

That’s a fairly broad statement, so, to build on it, here are some additional insights, gleaned from one-on-one interviews, published guidance from regulatory bodies, interpretations from leading thinkers in the pharmaceutical and medical device industries, and case law. The following themes capture the essence of current thinking about social media amongst regulators.

  • Current advertising and promotion rules apply, even if they were designed for traditional offline media such as magazine advertisements.
  • Regulators require that information be truthful and balanced, communicating both risks and benefits associated with the products being promoted.
  • In social media, it can be difficult to determine what’s a legitimate adverse event and what’s an online rant, but this is an area where regulatory bodies will be vigilant.
  • By definition, social media are uncontrolled. Yet companies will be held accountable for any offline promotion that happens on digital assets owned or influenced by them.

What Does It All Mean?

No regulatory body will ever be able to monitor and police social media completely. This means that manufacturers can get away with inappropriate online promotion. However, regulators around the world are upping their game in enforcement and, when they catch violators, they will make examples of them via large fines and public rebukes.

In addition, regulatory authorities that normally scrutinise the activities of healthcare companies will be aided in their enforcement efforts by other agencies, such as the US Federal Trade Commission or European Commission; or, due to jurisdictional crossover, the US Federal Communications Commission, Body of European Regulators for Electronic Communications or Asia Pacific Economic Cooperation Forum.

Finally, here’s a word of warning: There has been a tendency to rely on the ‘one-click rule’ for static Web sites, meaning that fair balance information had to be available via a single click to another link. Yet recently, multiple agencies have said that they never agreed to this rule, meaning it is not a safe haven.

Interestingly, regulatory bodies are hiring social media experts at a rapid clip and have embraced online tools and social media to advance their own agendas. For example, US FDA already has taken to ‘tweeting’ news of recalls to offline media and the wider world.

What Can I Do?

While it may not seem like it, the fact that regulators continue to discuss social media is good news. Remember, early on, there was a movement to ban entirely the use of social media by pharmaceutical companies and medical device manufacturers. This seems unlikely now.

Critically, social media must be integrated throughout your organization. By embedding it in the business, the odds of reducing risk and increasing ROI increase exponentially. By embracing social media and bringing together groups like Legal, Compliance, Regulatory, Quality Assurance, Marketing, Communications, Digital Business… even HR and Training, you can find ways to use social media effectively and prudently.

Next, if we show regulators that we will do the right thing, we improve our chances of avoiding counter-productive guidelines that hurt the healthcare industry and don’t help patients or clinicians. Assume that social media activities will be scrutinised using existing regulations, the ones used to judge traditional or offline communications.

Here’s a simple rule of thumb for self-policing: Apply the rules you use for offline promotion to what you do online. For example, if you determine that a brochure must have a disclaimer, put the same type of disclaimer on your site or in your email.

A corollary to this point is that we must ‘own’ social media. It cannot be an afterthought or ‘someone else’s job.’ Some ways to do this include the development and implementation of policies governing employee use of social media, including monitoring compliance and enforcing those policies. Set up Digital Councils, with senior leaders engaged, to ensure that policies are reviewed regularly and, even more importantly, that they are involved in the development of effective, defensible online strategies and structures. Then, drive your digital policies and strategies throughout your organization, including to field personnel.

Partner with industry groups so you can be part of the conversation with regulatory bodies as they clarify their social media guidelines. Closely track warning letters and regulatory findings from around the world to avoid mistakes your peers make when they use social media.

Also, participate in all regulatory meetings and provide key agencies with information when requested and, when possible, in advance of decision-making and policy-setting.

Finally, it seems simple enough, but pay attention. The Internet policies of regulatory authorities may emerge quickly over the next two years. Assuming so, you may have a chance to respond to draft guidance documents, participate in hearings, even help draft regulations. Take advantage of these opportunities.

In closing, here is a thought that will shape how we communicate with and engage our target audiences. We may actually leap from where we are directly to mobile marketing and communication. We have invested relatively little thus far in ‘traditional’ online activities, and mobile computing is the future. So we have an opportunity to lead the way to better health for our patients, more support for our caregivers, stronger relationships with our clinicians and more efficient delivery of care, powered by mobile tools.

More on that later…


1 Juniper Research study, December 2011
2 BtoB Magazine survey, April 2011
3 Kantar Media, “Pharmaceutical Marketing – State of the Industry in 2011,” November 2011

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