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FDA Guidance Reveals Openness to Pharma Social

Intouch Team

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On January 13, 2014, the U.S. Food and Drug Administration (FDA) released draft guidance on the postmarketing submission of interactive promotional media. The intent is to provide clarity for marketers who promote products using digital communication channels, such as company-owned blogs or third-party platforms like Twitter and Facebook.

The document is not comprehensive “social media guidance”; rather, it is another in a series of guidance documents following the 2009 hearing addressing the ever-changing world of digital and social communications. According to the FDA website, they are developing a variety of guidance concepts, including:

“ … how companies should respond to unsolicited requests for information about off-label use, issues with space limitations, fulfilling post-marketing submission requirements, accountability, use of links on the Internet, and how sponsors should correct misinformation about their products disseminated by third parties.” 1

Technically, this document covers what digital promotional activities constitute submitting a Form 2253 (human health) or Form 2301 (animal health). But inherently, the document also clarifies what the FDA considers its regulatory domain when it comes to user-generated content (UGC) and illuminates what the FDA is most concerned about enforcing in this area.

This draft guidance focuses on four key elements that impact digital communications in pharmaceutical and animal health marketing, especially when it pertains to UGC: the channel, the message, the communicator and the submission requirements. As companies analyze the guidance within the context of their own communication activities, they should consider each element and the potential impact to their internal and external policies and processes.

This point-of-view addresses those four areas and provides recommendations and next steps for companies affected by the guidance.

Timing is Everything: Patients First, Paperwork Second
With this draft guidance, the FDA acknowledges that the timing of digital communications presents a unique challenge. While the Federal Food, Drug, and Cosmetic Act requires companies to submit promotional materials at the time of initial publication, the FDA recognizes that same standard may not apply to real-time communications within channels such as Twitter or Facebook. With respect to sites that are wholly owned/controlled by the pharma company and include interactive components, the draft guidance requires that:

“At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product website with the addition of any interactive or real-time components.”

In situations, however, where the pharma company is engaging in communication on publicly available sites that it does not own (e.g., third-party forums, external blogs), the FDA provides expanded submission guidance, indicating that the company should submit:

“ … the home page of the third-party site, along with the interactive page within the third-party site and the firm’s first communication … at the time of initial display.”

After first submission, as long as the site is publicly accessible, the company may then submit a monthly updated listing of the UGC sites for which it is responsible or in which it remains active. Multiple sites can be submitted with a single form. This alleviates the need to submit screen captures of the communications, lightening the workload for pharmas, agencies and the FDA.

In situations where pharmas engage in conversations in private forums to which the FDA may not have access, the guidance does require that submissions contain full imagery and screen captures of the communications, but they can still be submitted monthly.

In addition to the benefit of lightening the submission burden for all involved, we see this clarification as one that provides the pharmaceutical industry with the ability to focus on the social conversation. Instead of hyper-focusing on ongoing submissions requirements, companies engaged in social media can now focus on engaging in real-time dialogue.

Control Over the Channel
The FDA defines promotional media as those including:

“ … modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that firms use to promote their drugs.”

Through this definition, the FDA is clearly recognizing that interactive media, such as discussion forums and social media channels like Facebook and Twitter, present unique challenges that aren’t present with traditional media. As such, the FDA is providing direction that pharmaceutical companies pay close attention to the channel where their promotional messaging is being delivered.

When communicating promotional content, the FDA places responsibility on any company communicating via channels that are “owned, controlled, created, influenced, or operated by, or on behalf of, the firm.” While pharmaceutical companies have long understood the requirement to submit promotional messaging to the FDA for those sites/channels created, operated or owned by them, the expansion of the definition to include “influenced” is a distinction that may warrant pharma marketers’ attention. In the guidance, the FDA indicates that if a pharma company “collaborates on or has editorial, preview, or review privilege over the content provided, then it is responsible for that content.”

In some situations, pharma companies may submit promotional content to third-party sites and indicate that they prefer for the content to be displayed specifically to a segment of visitors or displayed only within specific disease-state sections of the site. In these situations, however, it appears that the FDA is indicating that any recommendations regarding placement would trigger the need to submit not only the promotional content, but the surrounding page content to clarify the context of the messaging.

As this guidance is still in draft format, it may be worth pursuing clarification with the FDA to gain perspective about the level of influence that will be required to trigger the submission of surrounding content. It may also be worth clarifying — as some industry pundits have assumed — if this guidance applies to advertising in social media spaces in addition to user-generated content.

Messaging May Make the Difference
While the draft guidance focuses very clearly on the promotional messaging (sometimes referred to in the industry as “branded content”), there are still some questions that remain unanswered regarding non-promotional messaging within a promotional channel. While the guidance clearly indicates that promotional content must be submitted to the FDA, the guidance lacks clarity regarding non-promotional content and conversations that take place on a promotional channel.

For instance, some pharma companies have established branded Twitter handles, complete with product branding and Important Safety Information (usually placed in the background image of the page). The channel owners often engage, however, in unbranded communications with other members of the Twitter community. The question remains as to whether every communication (promotional or non-promotional in nature) would be submitted to the FDA via the postmarketing filing process or if the pharma company is only required to submit those that are branded.

One important clarification that the FDA did provide in the draft guidance is that pharma companies will not be held responsible for comments made by third parties (often referred to as “user-generated comments”). Regardless of whether the comments were made on a channel owned by the pharma company (e.g., a company blog) or on a third-party platform (e.g., Facebook), pharma companies would not be required to file these promotional communications unless the company took action and responded to them with additional promotional messaging.

Training Those Who are Communicating
As the digital space evolves, so do the training requirements for employees, agencies and spokespersons for pharmaceutical companies. Per the draft guidance:

“ … regulation of prescription drug product promotion extends both to promotional activities that are carried out by the firm itself, and to promotion conducted on the firm’s behalf. Therefore, a firm is responsible for the content generated by its employees or any agents acting on behalf of the firm who promote the firm’s product.”

Through this verbiage, the FDA is reminding pharma companies to ensure that anyone speaking on their behalf follows the guidance. Whether communications come from company sales personnel, marketing professionals, agencies, paid celebrities or even paid bloggers, the pharma company will be required to evaluate real-time communications and determine whether a postmarketing filing would be appropriate.

Next Steps
The industry has 90 days to provide comments and suggestions on the draft guidance, but it’s not clear when final guidance can be expected. Mobile draft guidance was issued July 2011, but final guidance wasn’t issued until September 2013. Time will tell if we can expect the same timeline for this guidance. According to Regulatory Focus, the issuance of guidance on social media is required by the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 1121, and calls for the FDA to, by August 2014, “issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA].”

Regardless of timing, pharma and animal health companies should begin to take action now. Intouch Solutions recommends the following next steps based on this draft guidance:

  1. Review the draft guidance and determine whether it may have an impact on your existing policies, procedures and workflow regarding promotional marketing and submissions.
  2. Review your existing communication and social media policies and help employees understand the potential impact of the proposed guidance on their external communications.
  3. Review your existing policies regarding paid spokespersons — including KOLs and bloggers — and provide further training, if needed, to individuals regarding promotional conversations.
  4. Review any existing terms and conditions for your social media properties and determine whether the draft guidance warrants any updates or revisions.
  5. Work with internal and agency partners to provide the FDA with comments and suggestions related to the guidance within the next 90 days.

While the draft guidance provided by the FDA does provide some insights as to the treatment of user-generated content and establishes a process for filing promotional communications with the FDA after an online conversation has occurred, the guidance serves as a reminder that existing regulations already provide a strong foundation for communicating in the digital space. 

Leveraging the existing regulations and guidelines can provide a framework for any company to get started with a digital strategy that includes online communication with patients, caregivers and healthcare providers. Through this draft guidance, the FDA continues to clarify the process and provide answers to questions that are unique to the digital and social media space.

Intouch Solutions will continue to monitor the evolution of this draft guidance and will publish updates to this POV document as appropriate.


1 The FDA issued draft guidance on handling requests surrounding off-label use in December 2011; this new guidance addresses the “fulfilling post-marketing submission requirements” concept. The FDA also issued final mobile app guidance last year.


For more information and ideas about social media or this guidance, contact your Intouch Solutions representative.

The information contained in this document is for general guidance on matters of interest only. Intouch Solutions makes no representations as to the accuracy or any other aspect of information contained in linked websites. The information contained in this document is not, nor is it intended to be, legal advice.

© Intouch Solutions 2014

Author: Sean Nicholson, Senior Director, Social Media


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