FDA Says Its on Target to Issue Guidelines on Social Media by Year End But Will Not Address Adverse Event Issues

Medical Marketing & Media Magazine reports that FDA is on track to issue much sought after draft guidance by the end of 2010 on the promotion of regulated products via the internet and social media. Those following the issue will recall that FDA held hearings in November 2009 and solicited comments on suggested guidelines regarding the use of social media by FDA regulated entities. The primary issues that concerned both FDA and the industry were (1) the kinds of online communications manufacturers, packers and distributors could be held accountable for; (2) how those entities could fulfill regulatory requirements when using social media tools with strict space limitations, such as Twitter and other micro-blogging services; (3) what parameters should apply to the posting of corrective information on web sites controlled by third parties, (4) when the use of links from branded web sites to other informational sources is appropriate; and (5) a number of questions specific to how FDA regulated entities should respond to or report alleged adverse event reports gleaned through the internet. Jean-Ah Kang, Special Assistant with the DDMAC, indicated that FDA intends to address all of the issues discussed, with the exception of adverse event reporting.

FDA's failure to provide guidance regarding how the industry should handle adverse event reports causes some level of concern. As stated in the Federal Register notice, FDA expects that entities responsible for reporting will promptly review all adverse event information obtained through the internet and social marketing sources and report such adverse events to FDA when appropriate. FDA noted that this responsibility raises a number of important questions, including how entities with postmarketing responsibilities are using the internet to monitor adverse events, and how adverse event information is being received, reviewed and processed. In addition, FDA sought information regarding the kinds of challenges presented in handling adverse event information, and the kinds of uncertainties the industry faces regarding what should and should not be reported from these sources to meet FDA reporting obligations.

From both a business and a legal standpoint, FDA's failure to provide guidance regarding reporting obligations is particularly problematic. The internet and social media tools contain an incalculable amount of information that increases constantly and exponentially. The industry needs guidance to determine what its responsibilities are to track alleged adverse event reports across a relatively infinite number of websites, blogs, microblogs, message boards and chatrooms. Is it responsible for policing only its own sites or must it also police third party sites? If it is responsible for reviewing and processing information from third party sites, must the sites have some level of legitimacy to fall within the industry's purview?

Also, in many, if not most, instances, the source of information is anonymous and unverifiable. How can a responsible entity determine which adverse event reports are legitimate and which are falsified? How can the entity determine the identity of the individual making the statement? How can the entity determine exactly which product or device was involved with the alleged incident? How far does the entity have to reach to learn this information? If the individual making the statement is completely anonymous and posting on a third party site, does the entity have to engage in subpoena practice to obtain the individual's identity or IP address? If so, does the entity have to then engage in further subpoena practice to obtain the individual's identity from their internet service provider?

Conceptually, the industry's reviewing and reporting responsibilities, and the costs associated with those responsibilities, are limitless. While its no surprise that FDA will not issue guidance regarding the above issues, we can only hope that it revisit the issue in the near future.

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