FDA Releases Social Media Draft Guidances
By Clinical Informatics News Staff
June 17, 2016 | The FDA has finally released two draft guidances on how companies should deal with social media including comments posted on Twitter and third party blogs and sponsored links on search engines such as Google and Yahoo.
Among the recommendations for Twitter usage in the 18-page guidance, the FDA encourages companies to, "first carefully consider the complexity of the indication and risk profiles for each of their products to determine whether a character-space-limitation platform is a viable promotional tool for a particular product." Benefit information should be accurate and non-misleading, and should include risk information "within each individual [tweet]" FDA said. If that is too much of a challenge for 140 characters, the Guidance suggests, "then the firm should reconsider using that platform for the intended promotional message."
In the 12-page guidance for correcting third-party information, FDA emphasizes that companies are "generally not responsible for" misinformation produced by third-parties that are truly independent of the company, even of that information appears on a platform the firm owns or operates. However, in a variety of examples, the company may choose to correct online misinformation. The guidance defines what "appropriate corrective information" would entail including that it be relevant and responsive to the misinformation, limited and tailored to the misinformation, non-promotional, accurate, and disclose that the corrective information comes from the company.
The FDA does not expect firms to submit corrections to the Agency, but does recommend that firms keep full records of their actions to "assist in responding to questions that may come from the Agency."
Both guidances are in draft form and are nonbinding. They are not published yet, but will be open for comment or suggestion for 90 days from the date they are published in the Federal Register. Comments are submitted on www.regulations.gov.
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