US Food and Drug Administration Social Media Guidance is a Start… Now what?

Just when you thought it might never come, on 30th December, the US Food and Drug Administration (FDA) published its first bit of social media guidance for pharmaceutical and medical device companies. Titled ‘Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices’, the document addresses precisely that topic.

Before diving into an analysis of the Draft Guidance, it is worth noting three critical things:

1)      Draft means draft. You can comment on the document for 90 days, until 29th March 2012. We encourage you to do so if the FDA’s proposal will have any direct impact on your business. (See ‘Useful Resources’ at the end of this article for details about how to submit comments.)

2)      When finalised, this guidance only represents the FDA’s ‘current thinking’ on the topic. It does not create any rights, nor does it or confer any rights on anyone. The guidance will not be binding to the FDA or the public; in fact, the agency states, ‘You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations’.

3)      The Draft Guidance addresses just one small issue associated with social media and the digital space in general – requests for off-label information.

On this final point, while the document is limited in scope, the FDA does, for the first time in its history, address emerging channels directly. That is worth celebrating!

What Does It Say?

The Draft Guidance uses more than 6500 words to get across two simple concepts:

1)      If asked about an off-label use of one its drugs or devices by an individual, companies can provide factual, previously published information about the product and the use in question.

2)      If asked about an off-label use of one of its products in a public forum (i.e., where more than one person can see or hear it), companies can respond, but only with information regarding how individuals can contact the company directly about getting an answer, as an individual.

Companies that do respond to individual requests must only supply ‘truthful, balanced, non-misleading, and non-promotional scientific or medical information’ that responds to the specific request.

The Draft Guidance includes more detailed and specific information about the FDA’s current thinking, but the above captures the paper’s core principles. The document also includes numerous helpful case studies to illustrate the finer points of the agency’s thoughts and recommendations.

What Can We Do?

We have a feel for what Draft Guidance can and cannot do. We understand the heart of the FDA’s thinking about responding to questions about off-label use of drugs and devices. Now what?

An article we published in November addressed the topic of what we as pharmaceutical and medical device marketers can do, in the absence of social media guidelines from regulatory authorities. The FDA’s Draft Guidance does not change our approach, and it is worth providing a summary of those recommendations here.

  • To reduce risk and increase return on investment, social media must be integrated throughout your organisation.
  • Do the right thing.
  • Apply the rules you use for offline promotion to what you do online.
  • ‘Own’ social media, don’t let it be an afterthought or ‘someone else’s job’. Drive your digital policies and strategies throughout your organisation, 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.
  • Participate in all regulatory meetings and provide key agencies with information when requested and, when possible, in advance of decision-making and policy-setting.
  • Pay attention. Regulatory guidelines and rules are likely to emerge quickly. If you’re on top of the debate, you may be able to shape guidance that will be critical to your future success.

In summary, we now have the first ‘stake in the ground’ from a regulatory body regarding the use of social media by pharmaceutical and medical device companies. While narrow in scope, this Draft Guidance gives us an indication of where future guidance might lead. The good news is that companies will have quite a bit of flexibility, as long as they are thoughtful in their approach to using social media.

Useful resources:

  • To download a complete copy of the Draft Guidance, click here.
  • To comment on the Draft Guidance:
    • Written comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.
    • The agency also accepts comments online.
    • All comments about the Draft Guidance must be identified by its docket number:
    • To ask questions or seek clarification about this Draft Guidance document, contact:
      • Center for Drug Evaluation and Research – Jean-Ah Kang, +1.301.796.1200
      • Center for Biologics Evaluation and Research – Stephen Ripley, +1.301.827.6210
      • Center for Veterinary Medicine – Dorothy McAdams, +
      • Center for Devices and Radiological Health – Deborah Wolf, +1.301.796.5732



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