FDA advances Additional Activities to Prevent Drug Overdoses

On February 16, 2023, Dr. Robert M. Califf, Commissioner of Food and Drugs – Food and Drug Administration (FDA) released the following statement.  “Addressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority for the U.S. Food and Drug Administration. Upon returning to the FDA as Commissioner, I expressed my commitment to respond to all aspects of this ongoing crisis. As an agency focused on protecting public health, combatting this evolving emergency is an issue of particular urgency for us. Of note, a public health emergency, as a consequence of the opioid crisis, was declared by the U.S. Department of Health and Human Services in October 2017 and renewed on December 22, 2022.  In August 2022, I announced the FDA’s Overdose Prevention Framework – our expanded vision to undertake creative actions with an impact not only on preventing drug overdoses and reducing deaths from opioids and other substances, but also ameliorating the tremendous toll of addiction on American individuals and families. As part of that announcement, I shared that the agency would commission an independent external opioid-related activities review. That review was conducted by a team of subject matter experts affiliated with The Ohio State University who are familiar with the 2017 National Academies for Sciences, Engineering, and Medicine’s (NASEM) recommendations, a project initiated on my watch, and also related opioid prescribing issues. The review analyzed the FDA’s implementation of the NASEM recommendations along with key regulatory policies and decisions, including labeling.  Today, we are sharing that report, which provides lessons learned, recognizes the work already being done by the FDA, and makes the following three overarching recommendations outlined for the agency to take action.  Continue efforts to comprehensively implement the recommendations in the 2017 NASEM Report, including evaluating scientifically-sound, inclusive study designs to inform a systems approach for regulatory decision-making that incorporates public health considerations.  Consider seeking from Congress certain additional authorities regarding opioid analgesic approvals and review of the advertising and promotion for such products, as well as additional resources to implement such authorities to strengthen oversight of prescription opioid analgesics.  Be as transparent as possible regarding decision-making for opioid analgesics, as increased transparency can encourage appropriate uses of prescription opioid analgesics, promote innovation in pain management and prevention of opioid use disorder, and enhance public trust.  We have reviewed these recommendations and while we are thoughtfully considering our actions to implement them, I am encouraged that the agency is already moving forward on multiple workstreams, while also adapting to the changing epidemiology of the ongoing public health emergency. New challenges confronting us include much more multidrug use and troubling distribution of powerful chemically-synthesized drugs.  While our response is centered on opioid regulation by the Center for Drug Evaluation and Research (CDER), all elements of the agency are involved as we work with digital applications of substance use disorder treatment, the inappropriate intermixing of prescription drugs—like certain veterinary medicines—in the illicit market, enforcement activities in the domain of the Office of Regulatory Affairs and the intersection of nicotine addiction with use of other addictive substances as the Center for Tobacco Products oversees tobacco products.”