FDA releases draft social media guidance for drugmakers

In draft guidance issued Tuesday, the FDA said drugmakers must be sure to disclose the "most serious" risks of their treatments when discussing their benefits on social media, as well as specify the precise indication for each product. Under the proposed guidelines, pharmaceutical companies will also be permitted to correct misinformation posted about their products on social media without having to strictly adhere to the agency's labelling or advertising standards, as long as the corrections are clearly defined, accurate and non-promotional.

The FDA acknowledged in the draft document that "for some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk." In such cases, the agency said companies should provide mechanisms, such as hyperlinks, "to allow direct access to a more complete discussion of risk information about the product."

With regard to comments made by independent third parties about a drugmaker's products, the regulator proposed that the companies be allowed to correct misinformation directly on the forum or submit the correct information to an individual blogger or website owner, adding that it would not hold companies responsible if third parties fail to correct the information. However, the FDA noted that leeway on not having to follow its labelling or advertising standards when addressing misinformation would not apply to comments made by company employees. Further, drugmakers will not be permitted to remove or edit postings on their websites that describe products in a negative light while adding those that portray them positively.

The guidance follows a public meeting held in 2009 to gather input on social media promotion, as well as previous draft proposals, including guidance on companies' responses to unsolicited online requests regarding off-label drug use. Commenting on the news, Lori Leskin of the Kaye Scholer law firm said "I think this is clear enough guidance you'll start seeing more tweets" from drugmakers about their products, noting however that "it's the more significant drugs that do have black box warnings, that do have more significant risk, that are used in limited populations that this won't be appropriate for."

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