FDA Teams With NASEM on New Opioid Guidelines

The U.S. Food and Drug Administration (FDA) has contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain, reports Regulatory Focus . FDA Commissioner Scott Gottlieb said NASEM will undertake a study and disclose its findings, starting with identification and prioritization of "procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices." He noted analyses "suggest that the first prescription for many common, acute indications could typically be for many fewer pills." NASEM also will examine current opioid analgesic prescribing guidelines to investigate how they were developed, detect any gaps, and outline studies needed to generate evidence. Gottlieb said the guidelines would differ from corresponding work by the Centers for Disease Control and Prevention as it would be indication-specific and based on evidence taken from assessments of clinical practice and pain treatment. NASEM also will organize meetings and public workshops to engage various stakeholders who can contribute on existing guidelines and on emerging evidence or specific policy issues related to the development and availability of opioid analgesic prescription guidelines.