
- Applied Clinical Trials-09-01-2011
- Volume 20
- Issue 9
Pharma Companies Lose Facebook Privileges
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
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
Articles in this issue
about 14 years ago
Applied Clinical Trials Digital Edition - September 2011about 14 years ago
Most Protocols Require Multiple Amendmentsabout 14 years ago
Recruitment Rolesabout 14 years ago
Uniformity Sought for Research Standardsabout 14 years ago
EMA Commits to London for a Quarter Centuryabout 14 years ago
Cell Phone Key to REMOTE Data Collectionabout 14 years ago
Clusters' Last Stand?about 14 years ago
Lost to Follow-Up Survey Resultsabout 14 years ago
Business and News Update September 2011about 14 years ago
Sneak Peak at FDA GuidanceNewsletter
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