In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. NASEM was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence where future research is needed. We greatly appreciate all the work done by NASEM to produce the consensus reportExternal Link Disclaimer released.
The FDA’s efforts to address the opioid crisis must focus on encouraging “right size” prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.
One of the ways we believe we can work together with medical professional societies is by developing a framework that can assist them in creating and evaluating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain caused by specific medical conditions and common surgical procedures for which these drugs are prescribed.
As part of their work, NASEM examined existing opioid analgesic prescribing guidelines, identified where there were gaps in evidence and outlined the type of research that will be needed to fill these gaps. NASEM also held a series of meetings and public workshops to engage a broad range of stakeholders who contributed expert knowledge on existing guidelines and provided emerging evidence or identified specific policy issues related to the development and availability of opioid analgesic prescribing guidelines based on their specialties.
Moving forward, the FDA will consider the recommendations included in the consensus report as the agency works to implement the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) provision that requires the development of evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist.
The FDA remains committed to addressing this national crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal importation and sale of opioid products.
