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On Tuesday, February 12, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. released a statement about the agency’s on-going efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and confront the opioid epidemic. ASA has previously advocated to the FDA on ways to reduce opioid misuse and abuse and is currently working with the American Academy of Orthopaedic Surgeons on a educational initiative to educate patients and providers about opioids.
Among the new steps the FDA is taking, the agency plans to publish new guidance that would replace their February 2014 analgesic development document. The new guidance would describe the FDA’s application of the risk/benefit framework to opioid analgesics, taking into consideration the full range of risks associated with these products, including the risks created by illicit use. To create this document, the agency will solicit input from the public later this year and also ask questions about how the FDA should be evaluating the safety and effectiveness of new opioid analgesics relative to the opioid drugs that are already on the market, and how this new information might relate to their evaluation of the risks and benefits of new products at the time of approval. In 2017, FDA took steps to expand the Risk Evaluation and Mitigation Strategy (REMS) program for opioids. The REMS program requires companies that manufacture opioids to provide certain education for prescribers of these medications. The expansion meant that REMS would apply to all classes of opioids, not just extended-release and long-acting (ER/LA). This is a policy long supported and advocated for by ASA. Around the same time, FDA updated its Blueprint for Prescriber Education, which describes the content that should be included in the REMS education, to incorporate pain management and extend training to other health care professionals. ASA submitted feedback to the FDA on the Blueprint and saw many of its recommendations reflected.
Again, the Society is pleased to see the FDA explore ways to improve the safety of opioids, including focusing on new products.
The FDA is also working to advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures, as well as advancing the requirement for certain packaging to limit the number of pills a patient receives through a single prescription.
ASA has recommended and advocated that the FDA work with medical and specialty societies to develop evidence-based guidelines on prescribing for acute pain. As mentioned, ASA and AAOS are already collaborating on a resource geared at safe opioid stewardship, which will complement this project. We are pleased to see the agency advancing this proposal and hope to work with the FDA on this effort.
