FDA Offers Guidance on Social Media, Web Communications

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The Food and Drug Administration has proposed draft industry guidance to ensure that social media and Internet communications relating to medical products are clear, accurate, truthful, and do not mislead the public.

Concerned that patients and healthcare providers regularly get information about FDA-regulated medical products through social media and other Internet sources, the agency drafted two separate draft guidances with recommendations to help manufacturers accurately communicate online about prescription drugs and medical devices.

“We developed these new guidances, in part, to respond to requests for best practices from companies and other stakeholders,” states a blog posting by Thomas Abrams, director of the Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research. “We gave careful thought to our draft recommendations, and we understand technology will continue to evolve. So we worked across FDA Centers and Offices to develop best practices that can be applied to existing online Internet sites — and those that have yet to be developed.”

The FDA’s first draft guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources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.

“We understand that communicating on electronic Internet sites with character space limitations can be challenging,” acknowledges Abrams. “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.”

The agency’s second draft guidance provides recommendations to companies that choose to correct third-party information related to their own prescription drugs and medical devices.

“This draft guidance provides FDA’s recommendations on the correction of misinformation from independent third parties on the Internet and through social media sites,” states Abrams. “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.”

The FDA is seeking comments and suggestions regarding its draft guidance documents, which can be submitted electronically at http://www.regulations.gov.


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