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FDA Releases Statement on 2019 Opioid Epidemic Agenda
On Tuesday, February 26, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. released a statement on how the agency plans to address the epidemic of opioid abuse in 2019. Commissioner Gottlieb highlights several key priorities of the FDA for 2019, including many supported by ASA, while building upon actions taken by the agency in 2018.
ASA is pleased the FDA is working with the National Academies of Science, Engineering, and Medicine (NAM) to create a scientific framework for developing evidence-based prescribing guidelines. This aligns with a broader NAM initiative which ASA is involved in, the Action Collaborative on Countering the U.S. Opioid Epidemic. The Action Collaborative is addressing key issues to respond to the opioid epidemic, including education and training; prescribing guidelines and evidence standards; prevention, treatment, and recovery; and research, data, and metrics. Workgroups on each of these issues will develop recommendations reflected in a future report. ASA member and Chair of the Committee on Regional Anesthesia and Acute Pain, Edward Mariano, M.D., was nominated by ASA to participate in the collaborative and is on two of the collaborative workgroups.
The FDA was granted new authority to reduce the risks of addiction and abuse associated with opioid analgesics in the passage of the SUPPORT Act; 2018 legislation to address the opioid epidemic. The 2019 FDA agenda reflects this and includes a focus on:
ASA is committed to educating the public and lawmakers about the role of physician anesthesiologists in reducing opioid misuse and abuse. Anesthesiologists are experts in pain management and uniquely positioned to address the opioid crisis. Through opioid sparing techniques, anesthesiologists can reduce patient exposure to opioids and reduce the number of opioid prescriptions taken home at discharge.
The FDA is prioritizing new efforts to further the development and use of Medication-Assisted Treatment (MAT). Also, the FDA is strategizing on ways to broaden the availability of naloxone, a life-saving medication that can rapidly reverse an opioid overdose. ASA has been a long-time supporter of increased access to naloxone, as well as co-prescribing by physicians when appropriate and even presented before the FDA in 2015. The Society also issued a Statement on Naloxone. The agency suggests naloxone should be available for over-the-counter (OTC) sale and is working to encourage manufacturers of naloxone to enter the OTC market. ASA is pleased with this effort and hopes it will lead to widespread availability of naloxone.
The SUPPORT Act also allows the FDA to require manufacturers to develop disposal technologies (such as mail-back pouches) as a way to remove unused medications from Americans’ households. This initiative will give patients additional options for proper disposal. ASA supports increased patient education on drug take-back and disposal and is partnering with the hospitals of Premier, Inc. to ensure patients are educated on safe use, storage, and disposal of opioids. This is one component of a pilot program where ASA and Premier are working together to reduce opioid use in the perioperative period. ASA physicians are providing education to participating hospitals on multimodal approaches to pain management, focusing on common high-volume surgeries (hip, knee and colectomy) to prevent opioid misuse and abuse. The project is in its second phase and will conclude at the end of March.
ASA welcomes the opportunity to work with the FDA on defining appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain. Physicians and patients need non-addictive pain treatment options.
ASA will continue to advocate to the FDA on strategies to reduce opioid abuse and misuse. The Society applauds the FDA for reinstating its efforts in the opioid epidemic and looks forward to continuing to work with the agency to address the opioid epidemic.
