• FDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
  • July 22, 2014 | Authors: Laurie A. Clarke; Colleen Heisey; Mark Mansour; Christopher M. Mikson
  • Law Firm: Jones Day - Washington Office
  • According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As described in a recent Washington Post article, FDA has begun the process of developing revised guidance, in light of a court decision two years ago reversing the conviction of a pharmaceutical sales representative for discussing certain unapproved uses of a drug with doctors.

    Off-label use of certain drugs is relatively common among the medical community, but the lengthy and expensive clinical trial process often deters drug manufacturers from seeking formal approval for these alternative uses. FDA generally prohibits companies from promoting their products to approved indications as reflected in the current prescribing information.

    Although current rules allow drug makers to share unabridged peer-reviewed journal articles with physicians (as long as they are distributed separately from promotional materials), FDA officials recently explained in a notice and response to a citizen petition that the Agency is working to harmonize its public health regulatory mission with the interests in the dissemination of truthful and nonmisleading information. FDA plans to revise guidance documents to better address how pharmaceutical firms should respond when they receive unsolicited information requests from physicians about off-label uses.