FDA Releases Draft Guidances on Social Media Usage

The U.S. Food and Drug Administration (FDA) has released two long awaited draft guidances for how medical device and pharmaceutical companies should and should not discuss their products online and, in particular, on social media.

“These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers,” wrote Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion on the FDA’s blog.

The first guidance Abrams explains, provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting.

“We understand that communicating on electronic Internet sites with character space limitations can be challenging,” Abrams said. “But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.”

This guidance gives detailed examples for the use of Twitter, which is limiting as it only allows 140 characters per message. The document acknowledges these limitations, but makes assertions such as if a product is mentioned with one benefit, at least the most severe risk should also be mentioned in the same marketing message, no matter what the length limitations are.

The second guidance provides recommendations to companies that choose to correct third-party information related to their own prescription drugs and medical devices. This draft guidance provides FDA’s recommendations on the correction of misinformation from independent third parties on the Internet and through social media sites.

“For example, we recommend that any corrections should address all misinformation in a clearly defined portion of a forum on the Internet or social media, whether the misinformation is positive or negative,” Abrams said.

The second guidance gives numerous examples of situations in which companies should or should not take on the responsibility of correcting misinformation. The agency stresses that it does not intend to monitor companies’ efforts to correct misinformation disseminated online, but it suggests that companies keep good records on every instance of misinformation and what steps it took to correct them.