Joint Citizen Petition Asks FDA for Clarity on Off-Label Use Manufacturer-CommunicationsJuly 11, 2011
By Dara Katcher Levy –
On July 5, 2011, seven pharmaceutical companies submitted a joint Citizen Petition requesting that FDA clarify its policies for industry about four distinct types of manufacturer-communications that often deal with off-label information – Manufacturer Responses to Unsolicited Requests; "Scientific Exchange"; Interactions with Formulary Committees, Payors, and Similar Entities; and Dissemination of Third-Party Clinical Practice Guidelines.
The first three types of communications have been addressed by FDA over the years, with FDA acknowledging, conceptually, that these communications are permissible and recognizing certain mechanisms for dissemination as appropriate. The Citizen Petition is requesting that FDA further clarify and formalize its policies in these areas through rule-making. The fourth area, Dissemination of Third-Party Clinical Practice Guidelines, has been a subject of much debate within industry. Although several DDMAC Warning and Untitled Letters have confirmed that promotional claims based on such Guidelines may be inappropriate, it is unclear whether these Guidelines can currently be disseminated in their original published state pursuant to FDA's Guidance on Good Reprint Practices.
As part of the request, the Citizen Petition makes clear that notice and comment rule-making is strongly preferred over FDA issuance of guidance documents. And as the Pink Sheet notes, although rule-making, and not guidance, is requested, there is hope that FDA will respond as the issues raised in the Citizen Petition are likely issues for which FDA, at least internally, already has policy and can better iterate its position. Some in the industry speculate that this Citizen Petition may help even if (or especially if) FDA takes no action on it – to the extent the government attempts to take enforcement action against a company on the basis of a communication subject to the Citizen Petition, it is possible that FDA's failure to clarify its position can be used as part of its defense.