FDA issues social media guidance

On Tuesday, the Food and Drug Administration issued “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” This draft guidance updates and clarifies FDA’s policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.

Guidance from the FDA is an important step, as it shows the FDA’s attention to these changing mediums. These channels help us listen to and participate in important conversations about health care in the United States. Therefore, we applaud the FDA for providing guidance and look forward to the evolution of health care conversation in digital media.

In advance of this guidance, AstraZeneca released a white paper back in February that examined the pharmaceutical industry’s use of social media to discuss medicines and diseases, while taking a look at the roles – current and future – the industry and the FDA should play in these ever growing communication channels.

Two primary themes are captured in the paper:

  1. Social media is a fundamental part of advancing public health.
  2. Pharmaceutical companies have a responsibility to engage more fully in social media.

Moving forward, we plan to work within the regulatory framework to ensure we are viewed as a trusted source of information about our medicines in the social media space, which includes this blog, @AstraZenecaUS on Twitter, and AstraZeneca’s Facebook page.