FDA Unveils Draft Guidance on Drugmakers' Social Media Use


On Monday, FDA released draft policy guidance indicating that pharmaceutical drug manufacturers and distributors would not be held responsible for information posted on social media about their products by consumers or providers, Modern Healthcare reports.


According to Modern Healthcare, the pharmaceutical industry has been reluctant to use social media platforms because it lacked FDA guidance on how such platforms could be used without violating certain prohibited promotion.

For example, pharmaceutical firms were concerned about being held accountable for social media posts by clinicians or patients promoting off-label use of their products. In addition, drugmakers are required to disclose side effect information when promoting their products, but social media posts by third parties might not include such data.

Details of Draft Policy Guidance

In the draft policy guidance, FDA notes that such companies are generally not accountable for user-generated content that is "truly independent," meaning it was not produced or solicited by the companies.

The draft guidance also states that pharmaceutical companies are not responsible for content published on websites they financially support but do not control editorially.

In addition, such companies will not be held accountable for promotional materials found on third-party websites as long as the pharmaceutical firms did not direct the promotion's placement on the website and did not have any other control or influence over the site.

Questions Remain

Experts say that there still are some unanswered questions that could deter pharmaceutical firms from embracing social media, such as:

  • When a social media post becomes advertising; and
  • How companies can include balanced information in social media formats that allow a maximum of 140 characters (Dickson, Modern Healthcare, 1/14).

to share your thoughts on this article.