FDA Social Media Rules Impractical, say Pharma Groups


Should pharma companies be held legally responsible for social media content on their products posted by third parties or on third-party websites? To what extent would it discourage them from interacting with consumers via social media? Would this then deny consumers correct information about their products?


Pharmaceutical groups have raised unanimous concerns on FDA’s draft social media guidance released in June 2014. (see http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf ). They fear it holds them accountable for misinformation about their products posted online by third parties over whom they have little or no control.


The Pharmaceutical Research and Manufacturers of America urged the FDA to limit the manufacturers’ accountability for online content to the extent it was developed or posted by or on behalf of the manufacturer. The also called for clear guidelines to correct misleading third-party information regarding their products’ off-label uses (including permission to link to any FDA-compliant site while doing so).


The Biotechnology Industry Organization pointed out the lack of clarity in FDA’s interpretation of the influence or control pharma companies were expected to have. It called for FDA to provide greater flexibility to manufacturers to correct misinformation on social media, including “broad protection under the First Amendment”.


The Medical Information Working Group asserted that pinning such responsibility on manufacturers would be “impermissibly broad” and beyond FDA’s statutory authority. They termed this impracticable in today’s social media context, where interactive communication and user-generated content are unpredictable.


Source: The Hill

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