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Focus on Regulation

Industry Waits for Some Signal That FDA Will Rethink Its Proposed Approach to Unsolicited Requests

With the comment period closed, industry stakeholders wait for some indication that FDA will rethink its approach to responding to unsolicited requests, as set forth in FDA’s draft guidance, Guidance For Industry – Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.  Since release of the draft in December 2011, stakeholder comments have been calling for FDA to consider the practical implications of its guidance, as the approach is too restrictive and fails to consider the venue in which an off-label request is made. (SeeFDA Should Loosen Leash On Responding to Off-Label Info Requests, Industry Says” – The Gray Sheet, April 9, 2012)

As previously reported, while a key focus of the draft is clearly on public requests arising out of Web 2.0 social media forums, the manner in which the draft guidance limits a firm’s ability to substantively respond to public requests raises serious concerns in a both electronic and non-electronic media forums, including first amendment free speech concerns (SeeFDA on Free Speech and How to Respond to Tweets” – MDDI: Medical Device & Diagnostic Industry, February 6, 2012). In light of the widespread concerns, it may be some time before stakeholders have an indication from FDA as to how the agency will proceed.