FDA Releases Draft Guidance on Responding to Unsolicited Off-label Requests

Posted 28 December 2011 | By Alexander Gaffney

The US Food and Drug Administration (FDA) released a new guidance for industry document on Tuesday titled, Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. The guidance addresses communications and activities related to off-label uses of legally marketed products and products still in development.

The guidance comes as a response to a citizen petition filed in July of 2011 of law firms Ropes Gray and Sidley Austin LLP on behalf of several major manufacturers, including Allergan, Eli Lilly, J&J, Pfizer, Novartis, and Sanofi. The petition requested clarification in four main areas: manufacturer response to unsolicited requests, the boundaries of scientific exchange, interactions with formularies and payors, and dissemination of third-party clinical practice guidelines.

The guidance notes the difference between promotional and scientific information, and affirms that the exchange of non-promotional scientific information has always been permitted.  Promotional claims regarding safety and/or effectiveness profiles for off-label claims, however, are prohibited.

The guidance also stresses the distinction between solicited/unsolicited requests and public/private solicitations for advice and makes recommendations regarding how to address these distinctions.

Of note to marketing professionals is Section VI of the guidance, which details how to respond to unsolicited requests received via social media.  While not constituting full social media guidance, this represents one of the first forays in to the regulation of social media by the FDA.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe