The FDA has also released draft guidance describing its current thinking regarding the dissemination of benefit and risk information for drugs and medical devices on social media platforms with character space limitations, including Twitter and sponsored internet advertisements. The FDA stated that this draft guidance does not apply to the promotion of drugs and medical devices through product websites, social media networking platforms, including individual product pages on Facebook or YouTube, or online web banners. This guidance is not binding and does not establish any legally enforceable responsibilities.
The guidance stated that manufacturers that promote drugs and devices on social media platforms with character space limitations should include all of the following information within the character space limitation: the brand name of the drug; the active ingredient(s); the benefits and potentially serious side effects; and a hyperlink to complete the risk information. The FDA acknowledged in its guidance that it may be difficult for some companies to satisfy these requirements within the character space limitation for risky products.
However, the FDA also stated in the guidance that as long as the serious risks of a drug or device are mentioned along with the benefits of the product within the character space limitations, companies can then just link consumers directly to the full risk information. For a prescription drug used in humans, the most serious risks would include any risks included within a boxed warning, any risks that could be life-threatening or fatal, and all contraindications from the drug’s approved labeling. For animal drugs, the most serious risks include any potential injuries that could result to human handlers or animals and the risk of any drug residues entering the human food supply. For medical devices, the most serious risks would include any particular risk that is associated with a particular use or population. The guidance further stated that if the company uses any technique to emphasize the benefits of the drug or device, the company should use similar techniques to represent the product’s risk information.
To review the FDA’s draft guidance, click here.