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FDA Issues Social Media Guidance for Drug and Medical Device Makers

Social media is increasingly being used to promote prescription drugs and medical devices. In an effort to prevent misleading advertisements, the U.S. Food and Drug Administration (FDA) recently issued new guidance.

Under federal regulations, any promotional labeling that makes claims about a company’s prescription drug or device must include certain information, such as the indicated use of the product and the associated risks. Moreover, risk information must be comparable in content and prominence to benefit claims within the advertisement.

Some forms of social media, such as Twitter, restrict messages to a certain number of characters. However, the FDA guidance makes it clear that the same rules still apply.

At a minimum, device and drug makers should convey the most serious risks associated with the product together with the benefit information within the character restraints of the social media platform, according to the FDA. With regard to a prescription human drug, the agency advises that the most serious risks would generally include “all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling.”

The FDA guidance also states that social media posts must include a direct hyperlink to a complete discussion of the risks. The landing page must be devoted exclusively to the communication of risk information about the product; accordingly, a hyperlink to a product’s home page that also includes benefit information and other claims or graphics would not be sufficient.

For products with serious risks, social media platforms like Twitter are likely not appropriate. According to the FDA, “if an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.”