Scott Gottlieb, MD, the commissioner of the U.S. Food and Drug Administration, called on agency colleagues to take "more forceful steps" to address the nation's opioid abuse crisis and announced the formation of a new opioid committee in an agency blog posted Tuesday.
In the blog, Dr. Gottlieb said he sent FDA employees an email discussing the first steps he plans to take to address the nation's opioid epidemic. The commissioner argued for forceful action and the utilization of the full scope of the FDA's regulatory tools to limit opioid exposure to appropriate clinical scenarios.
"Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don't expose them unnecessarily to prolonged use, which increases the risk of opioid addiction," wrote Dr. Gottlieb. "Moreover, as [the] FDA does in other contexts [of] our regulatory portfolio, we need to consider the broader public health implications of opioid use ... While there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take."
Dr. Gottlieb went on to announce the formation of the Opioid Policy Steering Committee, which will include senior FDA leadership and will be tasked with developing new tools and strategies for the agency to deploy against the drug epidemic. The commissioner will task the new committee with answering three initial questions:
• Should the FDA require mandatory education for healthcare professionals regarding opioid prescriptions?
• Should the agency work to limit lengthy opioid prescriptions to appropriate clinical circumstances?
• Is the FDA properly considering the risk of abuse related to new opioid drugs under evaluation for market authorization?
"These are just some of the questions I will be asking this new steering committee to consider right away, given the scope of the emergency we face," wrote Dr. Gottlieb. "In the coming days, I'll continue to work closely with the senior leadership of FDA. I want to know what other important ideas my colleagues at [the] FDA may have, so that we can lean even further into this problem, using our full authorities to work toward reducing the scope of this epidemic."
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