FDA plans new steps to address opioid crisis

FDA Commissioner Scott Gottlieb outlined on Tuesday the steps his agency is taking this year to fight the opioid epidemic.

FDA Commissioner Scott Gottlieb outlined on Tuesday the steps his agency is taking this year to fight the opioid epidemic. Noting that addressing the crisis is one of the agency's top public health priorities, Gottlieb reviewed actions the agency took against opioids in 2018 and said that this year, FDA will take further steps to build on those efforts. "We plan to implement the initial steps to require unit of dose packaging in the first half of 2019," Gottlieb noted. "Specifically, the FDA is considering use of this new authority to mandate that certain solid, oral dosage forms of immediate-release formulations of opioid analgesics indicated for treatment of acute pain be made available in short-duration packaging for outpatient dispensing." Additionally, he said the agency is taking "steps to consider a framework to allow us to formally evaluate each candidate opioid in the context of how a novel opioid might fit into the overall therapeutic armamentarium that's available to patients and providers, and address the question we're frequently asked as to whether new opioid drugs should offer some comparative benefit over existing drugs." FDA also plans to continue to evaluate the effectiveness of REMS programs for opioids, noting that they have recently heard concerns about the REMS program associated with transmucosal immediate-release fentanyl medicines, and whether the REMS program is working as intended. Other steps FDA plans to take include prioritizing efforts to advance the development and use of safe and effective medication-assisted treatment, with new guidance aimed at supporting the development of novel medicines and medical devices; expanding the availability of naloxone; issuing updated guidance outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain; promoting the development of abuse-deterrent formulations of opioids; and continuing to strengthen its enforcement activities that target those who unlawfully market or distribute illicit opioids and other unapproved drugs.