Social CRM in Healthcare: New millennial challenges in a ponderous regulatory environment

May 03, 2011
Barry Peters

Vice President of Corporate Quality and Compliance

This is an excerpt from an article printed in SOCAP CRM Magazine found here. The article was co-authored by Steve DeLabio, Strategic & Analytic Consulting, Epsilon.

As marketers in the pharmaceutical industry continue to evaluate Social CRM, solutions must be modified to address existing issues that are exacerbated by rapidly changing technology. It is noteworthy to point out companies and initiatives with the most success to date have used existing processes or offline equivalents and adapted them to Social CRM.  For example, using longstanding direct-to-consumer (DTC) guidelines to engage with patients/consumers, or existing sales representative communication rules with healthcare professionals establishes on offline reference point to then develop online processes.

Looking back at the large amount of attention Social CRM has received from pharmaceutical marketers and the energy that has gone into trying to engage in this space, the desire to play a role is clearly evident. Pharma companies have incredible amounts of information to add to the conversation; and they want to participate.

The majority of successes, depending on the platform, have either been unbranded disease information tactics to engage the patient, or branded initiatives complying with all the same rules as a static website; with both having limited to no interactions between member and or the sponsoring company. There are exceptions to the rule and a complete listing of pharmaceutical social media can be seen here: Jonathan Richman’s wiki on doseofdigital.com

Regulatory Update

In pharmaceutical promotion, regulatory control and guidance casts a massive umbrella over all promotion and plays an even larger role in emerging technologies. While it would help adoption if the FDA issued basic guidelines on issues such as linking versus scrolling for fair balance requirements, the better long term solution would be for the industry and each company to determine their own role to participate. The following issues all present opportunities for companies to decide how and where to participate, and all have regulatory implications.

  • Lack of FDA Guidance

Given the FDA Social Media Hearing in November 2009, and the recent passing of a soft deadline (end of 2010) for the FDA to offer comments back to the industry, the issue of “what does the FDA think” has garnered the most attention. The FDA not only has the ability to issue guidelines, but it is the regulatory body that administers warning letters and fines.

  • Big 3 Communication Requirements

The issues of adverse events (AE) reporting, off-label discussion and fair balance (the Big 3) are not new to Social CRM; but how they are handled warrants discussion.

For AEs, the issue is not how to track the adverse event as most companies already have the ability for phone and Web, but of due diligence in tracking all four of the FDA requirements (identifiable patient, identifiable reporter, suspect drug, adverse event), and the resources behind the scenes to ensure proper compliance. While it may seem like the identification and tracking down of all four criteria would be simple online, the issue of anonymity and how it can breed misinformation without repercussions can cause this to be a significant undertaking.

While no pharmaceutical company would knowingly make off-label comments, handling online comments by users is difficult. Just as all promotion must be consistent with the package insert, having the mechanisms in place to properly respond to comments and questions in the online environment have proved to be no small task.

This leads us to the last of the three issues— how to express fair balance in the Web 2.0 environment. The common misconception is that there is unlimited space on the Internet to include appropriate fair balance when engaging in the conversation. User experience testing has shown that content has a much better chance of being seen if it is accessed via a well-designed click and pop-up as opposed to scrolling many screens down. The dilemma here is the FDA ruled against the one-click rule in the 14 Notice of Violation letters in 2009. This was addressed at the FDA hearing and many companies responded to the topic, but again, the FDA did not offer any additional guidance as of yet.

  • Culture and Commitment

While not tied to a Medical/Legal board review session, a company’s culture and desire to interact online in Social CRM has just as big an impact. After all, the pharmaceutical industry has been involved in a primarily one-way communication style for a very long time. Marketers need to seek new avenues of feedback, to view this as a partnership in the healthcare customer relationship.

  • Promotional Matrix

It is important to differentiate the promotional matrix as it applies to pharmaceutical marketing and the types of customers:

Promotional Matrix

Based on the campaign and its matrix (message + segment + category), not only will different rules apply, but there are vast existing guidelines to use as a launching pad for Social CRM interactions. Start with DTC guidelines for branded Facebook groups or use sales force rules of engagements for online physician communities. While this will not provide complete answers for the challenges in the space, it will offer a baseline with known FDA positions to base your engagement. Decisions will still need to be made for resources and funding, but the basic assessment of issues to address is not as daunting as first glance

Where Do We Go From Here?

As technology (and social media platforms) evolve, the industry, as well as individual companies need to decide how they want to participate, because after all, most of the hurdles are already known. Most pharmaceutical companies now have cross-functional teams in place to review all aspects of engaging online and to ensure the company has a consistent and thorough plan. Social CRM, and the larger issues of knowledge sharing user-based content, has implications across all areas (marketing, research, internal collaboration, global). No longer can marketing work in a vacuum as consumers, patients, and healthcare professionals are consuming information from places not controlled or influenced by traditional marketing1. As with all marketing, the challenge is getting the content to those who need and want it: the right location or channel, the right format, and in a timely manner. At a minimum, everyone should be listening.  Listening can provide critical insights, views, and vocabularies that may not be uncovered by traditional market research.

Is there a ceiling of possible marketing/engagement participation in the life sciences industry for engagement in Social CR? Yes, but there is still room to grow, experiment, and find the appropriate place for your company and how it can play a role the evolving healthcare delivery system.


1 Epsilon – Social Media Impact in Driving a Proactive and Engaged Patient, May, 2010

Tags: