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Pharmaceutical Adverse Event Reporting Still Unclear

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In March 2001, the FDA issued a draft guidance entitled “Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines.” This guidance outlined the obligations pharmaceutical companies have for reporting adverse events they find on the Internet. Under this guidance, drug companies are required to report any adverse experiences described on sites that they sponsor if they have knowledge of the following four data elements:

1. An identifiable patient
2. An identifiable reporter
3. A suspect drug or biological product
4. An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product

Pharmaceutical companies’ requirement to report adverse events on the Internet to the FDA is one of the main reasons companies have shied away from engaging with consumers in social media, yet FDA’s most recent release of “social media guidelines” makes no mention of adverse events or what responsibility pharma companies have in reporting such events from user-generated content. The exclusion of this guidance keeps pharma companies struggling over what to do with social media – at a time when communication through these channels is critical. Social media has become a universal communication platform and pharma companies are missing a huge engagement opportunity by avoiding it due to unclear guidance.

Even without specific guidelines, many pharma companies have apprehensively dipped their toes in the social media pool by developing their own set of guiding principles. For example, companies that create communities on their own website often create policies advising patients not to mention specific events or identify themselves. Others may utilize automated services, such as IMS Health’s Adverse Event Tracker for Social Media, which identifies not only adverse events, but off-label comments and product misinformation.

Additional FDA guidelines for social media are scheduled to be released in July 2014, but pharma companies that wait for clearly defined compliance regulations may be waiting much, much longer and will miss out on great opportunities to build a more personalized user experience.






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