FDA’s Draft Guidance on Social Media: What You Need to Know

Earlier this week, the FDA provided two additional guidelines regarding pharmaceutical drugs and devices. The first guidance document focused on advertising and social media that had constraints on character counts. The second guidance document focused on incorrect information found on blogs, forums and other social sites, and what responsibilities a pharmaceutical company has to correct the information.

For social networks such as Twitter and advertising options such as paid search (PPC), the ability to communicate is limited due to character counts. A tweet is limited to 140 characters and the headline and description lines of a paid search ad on Google and Bing are limited to a total of 95 characters.

The FDA’s new guidelines provide insight into what actions a pharmaceutical company needs to take if they choose to make a ‘claim’ within the limited characters. As you can see below in an excerpt from the guidance, the FDA recommends incorporating risk information within the posting or ad.

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. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.

This is obviously extremely difficult; with limited character counts in both tweets and paid search ads, the ability to fully disclose risk is difficult. The guidance also calls out providing a mechanism to reach more information, which can be something as simple as a link directly to information regarding the risks. The guidance also highlights that if a claim or benefit is made, that risks should be listed in order of seriousness.

With CMI heavily involved in the management of paid search campaigns for both consumers and healthcare professionals, our recommendation based on this guidance is to never make a ‘product benefit claim’ within a paid search ad. This eliminates the need to include or directly link to risk information. “View more information about [brand name]” or “Dosing information for [brand name] here” are successful examples.

The second guideline focused around content on third party sites and the responsibility of the pharmaceutical company when incorrect information was found. For sites that are editable, such as Wikipedia, if a pharmaceutical company or a representative of the pharmaceutical company edits the page, they must edit it to include accurate information and also include fair balance information. In addition to this, if any edits are made, they should be noted where the content appears; in the example of Wikipedia, this would appear in the sources section on the bottom of the page.

When a site that is not editable such as a blog, forum or social network is displaying incorrect information, the pharmaceutical company can reach out to the content owner to assist and provide them with information in order to correct the content. This is not a requirement, but it is recommended. The pharmaceutical company will not be responsible if the content owner does not make the changes, but should document any communication that occurs.

Any information provided to a content owner or added to an editable site must not be promotional in nature and only provide factual information. The additions should mirror the FDA approved product labeling.

How Does This Affect You?
While the additional guidance from the FDA provides insight into how pharmaceutical drug and device manufactures can interact and operate in the digital space, additional direction is still needed regarding claims and benefits.

To be safe, pharmaceutical companies should limit the use of claims or benefits in any communication that has character limits that prevent the ISI or risk information from being shown. This could prevent any issues with the FDA, as their guidelines do not provide enough detail.

This guidance, accompanied by previous guidance from the FDA, shows that the social landscape is an acceptable venue for pharmaceutical companies to interact with patients and healthcare professionals. But when doing so, they need to completely understand what their responsibilities are and formulate the right strategy in the beginning. Additionally, we recommend that prior to tweeting or blogging, companies and brands should leverage social listening and analysis to understand the perception of their disease state brand on social media.