The Food and Drug Administration (FDA) released a draft guidance on June 17th titled “Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”.
The purpose of this document is to provide a general set of guidelines, or “recommendations” as mentioned in the guidance, to Pharmaceutical and Medical Device companies who choose to promote their products on Internet/Social Media sites that have character limitations. Examples of these types of platforms that are stated in the draft guidance are online mircroblog messaging (Twitter) and online paid searches (“sponsored links” on search engines like Yahoo and Google). These guidelines, however, do not include actual product pages on websites; a product page on Twitter would not need to follow these recommendations, just the “tweets” that are posted.
The guidance proceeds to explain that if a company chooses to promote the benefits of the product then the risks associated with the use of the product will also need to be listed within the same communication. FDA suggests that the firm should, at the least, incorporate the most severe risk associated with the use of the product. In listing the benefits and risks of the product, the company needs to make the information easily understandable to the average reader as well as accurate and non-misleading. To assist with informing the reader of all of the risks associated with a product, FDA advises companies to add a hyperlink in the character-space-limited communication that links directly to a webpage that reveals further risk details about the promoted product. The title of the hyperlink created should suggest that the link directs to an informational page and should in no way be promotional or misleading.
Specifically towards medical devices, the document states, “labeling for an approved premarket approval (PMA) for class III medical devices or use information consistent with a cleared intended use for 510(k) medical devices provides the basis for the benefit information related to devices.” This type of information should be listed within the character-space-limited communication to avoid being misleading. Also, if a specific risk is related to a certain identifiable use or population, then each of those should be incorporated.
Another large point made in the draft guidance is that if a firm concludes that the necessary benefits and risk information, as well as other essential information, exceeds the character-space-limited communication, then the firm should reassess the use of that particular internet/social media platform. To save space in the communication, abbreviations for chemical names as well as punctuation marks and symbols may be used. Other essential information that should be included in the communication is the established name following the brand or trade name and the generic name of the product. For the landing pages of the hyperlinks included in the communication, the same information listed prior should also be represented.
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- For further information on this topic, view the full FDA Draft Guidance Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
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