This year I began a two-year appointment as Chair of the FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC). Our committee is asked to convene several times a year to discuss and advise the FDA on new drug applications (NDAs) related to the practice of anesthesiology and pain management.
Most AADPAC meetings are held to discuss novel opioid formulations, such as abuse deterrent opioid formulations (ADFs). On some occasions, the meetings do not concern NDAs, but are held to provide our opinions to the FDA about opioid-related topics such as naloxone availability, or the effectiveness of the TIRF (transmucosal immediate release fentanyl) REMS (risk evaluation and mitigation strategy) program.
This June we will discuss the utility and safety high dose opioids in the outpatient setting. Advisory committees are convened at the discretion of the FDA, but in 2016, as part of the Opioids Action Plan, FDA expanded the use of the AADPAC to include all NDAs that are either non-ADF opioids, or ADF opioids that “raise novel issues”. Read More