FDA Chats Up Industry With Two New Draft Guidances on Social Media

In June 2014, the Food and Drug Administration issued two draft guidance documents regarding product promotion and social media: (1) “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”; and (2) “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

While the draft guidances are not legally binding, they offer insight into FDA’s expectations and issues for industry to consider as it continues to develop social media campaigns.

The documents are the latest installments in a series of guidance documents the agency has promised to provide industry, in an effort to clarify the parameters and the agency’s enforcement interpretation on promotional messaging using ever-changing social media. FDA has requested comments by September 16, 2014. It recognizes the issues are daunting and need industry input. This Bulletin summarizes some key points of the guidances and offers AGG observations. For purposes of brevity, we will not describe all of the examples presented by FDA in the guidances.

Correcting Independent Third-Party Misinformation

Defining Control

  • As we have advised clients previously, control of the message is central to FDA’s determination of whether the product owner has regulatory obligations to comply with labeling and advertising requirements.
  • The agency makes clear that any correction is voluntary and not required by the agency. FDA’s intent is to provide guidance for “if they [firms such as manufacturers, distributors, or packers] choose to respond . . . to misinformation created or disseminated by independent third parties.” (emphasis added)
  • The new draft guidance does not apply when the firm is responsible for the product-specific communication (i.e., “owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm”).

To review the entire document and formatting for this alert (e.g., footnotes), please access the original below: