Alexander Gaffney of raps.org posted an interesting article regarding the use of Internet and social media platforms in FDA regulated industry. Many companies have been using such resources to promote products and answer customer questions; however, FDA has been known to issue warning letters and sanctions for “unapproved” or “misbranded” commentary, leading industry to demand guidance. In response, FDA has released two draft documents outlining the requirements and limitations for the use of Internet and social media platforms among drug and device companies.
Released in June, the most recent draft guidance specifically applies to networks with character limitations such as Twitter and sponsored links via Google or Yahoo. As the guidance suggests, FDA is requiring each individual post to contain “material facts about the use of the product, such as limitations to an indication or the relevant patient population…and at a minimum, the most serious risks associated with the product.” For most companies, the task of generating a promotional message to fit these criteria within a limited number of characters is near impossible. FDA urges these firms to reconsider the use of certain social media platforms in this regard .
To read the full article, click here.