The Center for U.S. Policy submitted a comment in response to the Food and Drug Administration’s (FDA) draft guidance, “Development of Non-Opioid Analgesics for Chronic Pain; Guidance for Industry,” expressing support for the agency’s efforts to advance the development of safer, non-opioid pain treatments while identifying several areas of concern that warrant further clarification. Specifically, the comment notes that the guidance may insufficiently distinguish between different classes of opioids, despite meaningful variations in their risk profiles and clinical utility. It further highlights the lack of clear parameters surrounding the requirement for “strong scientific justification” to generalize efficacy across pain conditions, which may introduce uncertainty and limit innovation. Moreover, while recognizing the importance of reducing opioid-related harms, the comment cautions against an overemphasis on opioid reduction that could inadvertently limit access to necessary therapies for certain patients. Overall, it recommends that the FDA improve the guidance to balance the promotion of non-opioid innovation with the preservation of appropriate opioid access and the establishment of clear, practical development standards.
Read the comment.