Social media has grown from its simple beginnings of sharing personal information, pictures, opinions and current activities. Companies now utilize its power to reach customers regarding products and specials and news agencies send out headlines and teasers. The reach and purpose has grown beyond updating an individual’s status to a tool to communicate with potential customers. You can even like the FDA on Facebook. (For some Life Sciences manufacturers, there is a tinge of an oxymoron there.)
Patients and consumers utilize the internet and mobile devices to search for healthcare related information to help them make well informed decisions. Some healthcare companies are using social media to provide and promote product information. After years of development, the FDA has issued two draft guidance documents to assist manufacturers with creating appropriate content to communicate information on medical products when using social media.
The traditional modes of communicating information have been regulated by the FDA for years to ensure that it is truthful and accurate. The same oversight is levied on digital healthcare - be it web based or via apps - and violations can lead to regulatory action.
Short and Sweet
The first guidance document provides direction for the appropriate means to communicate risk and benefit information when character space is limited. The important message here is a balance between the two. Any claim information must include the associated risks. This is a challenge with the character limitations. Posting benefits and then a link to risk information is apparently not acceptable. The same is true for retweets. If a company retweets a third party message that only includes indications the company would be at risk. It is also encouraged to provide a means for the end user to get more information.
To Correct or Let a Sleeping Dog Lie
The second document provides direction to companies who need to correct information from a third party keeping in mind that the correction needs to maintain an appropriate balance. It should be consistent with the labeling/intended use and the source of the update should be noted. So if the misinformation was about a particular indication, then the correction should be specific to that issue and not introduce any additional information in the form of promotion. Another key point is that the company is not obligated to correct the information. They may consider it too risky to fix the misinformation if they make an error themselves during the correction. So if the correction is in some way not in line with acceptable language, the company can be cited.
It has been a long wait for these documents. Some companies may have been reluctant to jump into the social media pool for fear of regulatory reprisals especially in the absence of agency guidance. These social interactions might be viewed as inaccurate product promotion. The risk to the company outweighed any potential benefit realized from using social media. Perhaps that pool is a little less murky now.