FDA extends comment period for Draft Social Media Regulations

By: Nichole Geary

On June 18, 2014, the FDA released Draft Social Media Guidance for the marketing of medical devices and pharmaceuticals. The Draft Guidance addressed such issues as risk disclosure in light of the character limitations of social media platforms and the responsibility to address incorrect or misleading information posted by unaffiliated third parties on third party websites.

Key takeaways from the Draft Guidance:

  1. Under certain circumstances, a firm is responsible for product promotion on third-party sites
    1. Responsible if a firm has any control or influence on the third-party site;
    2. Responsible if a firm collaborates, or has editorial, preview, or review privilege; and
    3. Responsible if a firm influences the placement of its promotion within the third-party site.
  2. Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.
  3. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product in the character-space-limited communication.

The original deadline to submit comments prior to the release of the Final Rule was September 16, 2014. Due to multiple requests by the industry, the FDA has extended the comment period to October 29, 2014. Medical providers should take note as the advertisement regulations apply not just to medical device and pharmaceutical manufacturers, but to any party that advertises a prescription drug or procedures performed with a particular medical device on social media.

The Draft Guidance and Notice of Comment Period are available here.

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