FDA Issues a guidance on their position on the use of social media

Drug and device makers have asked for regulators to issue rules on the use of social media. Earlier this year, the FDA issued a draft guidance to address how companies should respond to certain requests for information on off-label use of products. Although the draft guidance will not give the device and drug manufacturers a roadmap to navigate social media sites such as Twitter and Facebook, it does provide some direction on how companies should process without getting in trouble with regulators.

The rapid growth of the Internet, and especially social media sites, has made it easy for consumers and health care professionals to seek and share information about medical devices, procedures, and treatments. As a result, companies may see request for off-label use of their product through the use of websites, chat rooms, and discussion boards. The questions regarding off-label use are usually directed to users of the site, and this information can also be available to a wider audience than originally intended.  

The guidance outlines what the FDA considers to be an unsolicited request for information on an off-label use of an approved product. This includes requests made directly to the companies, as well as requests made in public forums and on the Internet.  The guidance provides some clarity on how device and drug companies should respond to these requests.

To access a PDF copy of the draft guidance, click here.