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Open Facebook walls could bombard companies with AERs.
Recently, pharmaceutical companies have started to embrace social media, in part due to Facebook's agreement to allow closed walls on pharma Facebook pages. This prevented people from commenting publicly on the site, thus avoiding customer complaints about drug side effects. But in an impromptu move, Facebook decided last month to take away pharma's special rights, causing many to panic and jump ship.
Companies such as AstraZeneca decided to close down their Facebook pages rather than risk possible adverse event reports (AER), while others such as Pfizer have opted to keep their page but closely monitor it for any unacceptable comments.
So what's pharma so afraid of, and are their fears warranted? Companies are concerned that comments about negative side effects will mean an onslaught of AERs that will need to be submitted to the FDA. But according to a podcast from http://www.drugsafetydirections.com/with Elizabeth Garrard, Chief Safety Officer for Drug Safety Alliance Inc., a study showed that only one in 500 messages could be reportable as an AE. This is because most messages lack one or more of the four items needed in order to be considered a reportable AE: the drug, adverse event, identifiable patient, and identifiable reporter.
Despite these statistics, Stewart Geary, Vice President and Global Head of Pharmacovigilance at Eisai Co., Ltd., notes that even though there may only be a handful of reports that would need to be submitted to the FDA, "the variety of international regulations and their various interpretations by pharmacovigilance inspectors from regulatory agencies potentially require that a company collect, save, and periodically evaluate in aggregate all such information even when it is fragmentary and does not allow meaningful assessment."
Geary goes on to comment on the lack of regulatory guidance in this space, "I think that this is an example of how complex regulation inhibits the ability to take advantage of technological innovation." —Kayda Norman