Seven Major Pharmaceutical Companies File Citizen Petition Seeking FDA Guidelines Regarding Off-Label Information

Jul 11, 2011   
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On July 5, 2011, seven large pharmaceutical manufacturers filed a citizen petition with the U.S. Food and Drug Administration (FDA) asking the Commissioner to “clarify FDA regulations and policies with respect to manufacturer dissemination of information related to new uses of marketed drugs and medical devices.” This citizen petition is an effort by pharmaceutical companies to push the FDA to clarify unresolved issues related to requests for off-label information, use of third-party clinical guidelines, and communication about off-label uses. Allergan, Eli Lilly & Company, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk, Pfizer, and Sanofi-aventis U.S. all signed this citizen petition.

The lawyers representing these pharmaceutical companies explained that the “current state of regulatory guidance is not clear or comprehensive” and “places manufacturers at risk of criminal and civil sanctions if they cannot correctly guess where the government would draw a line [on information about off-label uses]”. The citizen petition claims that despite the industrys efforts to piece together the agencys position from Federal Register documents, guidance, letters, and similar pronouncements, the FDAs vague language continues to create significant obstacles for stakeholders. Absent clear guidance or rules from the FDA, individual manufacturers have had to resort to inferring operative law and “what they believe is the correct interpretation” from the Agencys materials. As a result, “each individual manufacturer may either over- or under-communicate clinically relevant information, with significant attendant consequences for the public health.”

The citizen petition requests the FDA accept the following proposals:

  • Manufacturer Responses to Unsolicited Requests”The FDA should promulgate binding regulations embodying the FDAs current policy on responses to unsolicited requests, assure the policy affords manufacturers a balance between prohibiting off-label promotion and allowing appropriate dissemination of information related to off-label uses, and clearly distinguish a non-promotional response to an unsolicited request from product promotion.
  • “Scientific Exchange””The FDA should clarify its position on scientific exchange. In particular, to qualify as a “scientific exchange” statements must 1) make clear that a use or product is not FDA-approved or FDA-cleared, 2) make no claims that a use or product has been proven to be safe or effective, and 3) be truthful and non-misleading when measured against available information on the use or product.
  • Interactions with Formulary Committees, Payors, and Similar Entities”The FDA should address whether, and to what extent, economic or other product-related information may be shared with payors.
  • Dissemination of Third-Party Clinical Practice Guidelines”The FDA should address whether, to what extent, and when a manufacturer can disseminate third-party clinical practice guidelines when the guidelines are 1) developed by nationally recognized scientific medical organizations or agencies, 2) reproduced in similar format as the original publication, 3) reproduced by the manufacturer to include all products with the same indication, and 4) accompanied y relevant disclaimers and disclosures.

The manufacturers argue that in addition to helping pharmaceutical companies in their day-to-day decision-making, clearer guidelines would help to better safeguard the public health. These guidelines would help manufacturers better understand how to provide physicians information about risks of medical product use, which would help guide physicians in their treatment of patients. By filing this petition, “we think [it] is an important step in making the marketing rules more transparent” and “[e]nhanced transparency will be helpful to all stakeholders,” said one of the lawyers who worked on the petition.

Fuerst Ittleman will continue to monitor the progress of the FDAs response to concerns regarding off-label use. For more information, contact us at