by: Jeff S. Gibson, Attorney
The FDA is responsible for regulating the manufacture, sale, and distribution of drugs and medical devices in the United States including the oversight of the labeling of drugs and medical devices and the advertising of prescription drugs and restricted medical devices.
Digital communication related to advertising, more specifically—blogs, Twitter, Facebook, and company websites– is one area that the FDA has not specifically addressed until recently.
More patients are turning to the internet to gather information about medical conditions and treatment options. Drug and medical device manufacturers recognize the opportunity to market products via social media and have been waiting several years for the FDA to offer guidance more specific to that medium.
The FDA recently provided two social media guidance drafts to the public and is accepting comments until September 2014.
Twitter & Paid Search Ads
The first guidance deals with the topic of microblog messaging (Twitter) and online paid search (sponsored links on search engines), both of which have character space constraints. The concern with these media is the issue of having enough space to provide the required information for the promotion of these products.
The FDA specifically addresses how manufacturers can meet the requirements for promoting drug and medical device products using these space-limiting media:
- Benefit information should be accurate and non-misleading and reveal material facts within each message or tweet
- Benefit information should be accompanied by risk information within each message or tweet
- A hyperlink to a landing page or website that provides specific information related to product use, risks, and benefits should be included within each message or tweet
- The trade name and common name should be included within each message or tweet and the dosage should be prominently displayed on the accompanying product landing page
The FDA then states that if a manufacturer concludes that if there is not enough space in the messaging platform to adequately address the bullet pointed items above, then it should reconsider using those media for promotional purposes.
The guidance also states that a landing page or website dedicated to the risks and benefits of the drug or medical device providing a means to allow direct access to a more complete discussion of the risks associated with its product can satisfy issues related to space constraints on microblogging and online paid search profiles. A hyperlink to the landing page should be included in communications on social media for easy access.
The FDA is currently accepting comments from the public related to these social media guidelines for the next 90 days. Comments can be submitted electronically at http://www.regulations.gov