Responding to Unsolicited Requests for Off-Label Information - New FDA Draft Guidance


The Food and Drug Administration (FDA) issued a draft guidance on December 30, 2011 in response to stakeholder requests for clarification on how manufacturers and distributors of prescription drugs and medical devices, as well as animal drugs, can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information). The issuance of the draft guidance follows a public hearing held in November 2009 and a citizen petition, filed on behalf of seven prescription drug manufacturers in July 2011, seeking clarification on FDA’s current policies.

Among multiple recommendations, the draft guidance addresses how firms should respond to requests for off-label information that occur in public forums, including the internet and electronic social media. The agency’s positions also have potential implications for enforcement related to offlabel promotion and advertising. The draft guidance states that if a firm responds to unsolicited requests in the manner described, the agency does not intend to use such responses “as evidence of the firm’s intent that its product be used for an unapproved or uncleared use. In addition, such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising.” Notably, however, in the draft guidance, FDA very narrowly construes what would constitute an “unsolicited” request. The agency seeks comments on the draft guidance by March 29, 2012.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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