As I see itEven a cursory review of FDA's April 28, 2011 Federal Register Notice, soliciting comments on several proposed consumer studies testing different ways of presenting benefit and risk information in online DTC prescription drug websites, reveals how far away FDA is from issuing guidance on key issues of concern to industry. A conspicuous example is the use of hyperlinks to provide risk information.
In its 14 Notices of Violation on the use of hyperlinks in sponsored search results, FDA categorically rejected the possibility that providing information via such links could possibly constitute “fair balance.” This was a key topic of discussion at the November 2009 FDA public hearings on social media. It was anticipated that FDA's draft internet guidance (delayed twice with no specific target date yet set), would address the key question about the possible use of hyperlinks to provide risk information in a variety of online and social media formats.
FDA's categorical rejection of the use of hyperlinks to provide risk information is not required by law, and is in fact inconsistent with the approach FDA has taken in other analogous contexts. It is quite clear, however, that any FDA guidance on this subject is quite a long way off. For example, the Notice says that “the series of studies…will provide data that, along with other input and considerations, will inform the development of future guidance.” This leaves industry with at least two choices. Refrain from engaging in any behavior that is the subject of any of the proposed studies. Or, more reasonably, make rational decisions about what is and is not justified, from a legal, policy and communications standpoint and be prepared to defend those decisions.
Arnie Friede is principal of Arnold I. Friede & Associates