FDA Foundation Releases Reports on Substance Use Disorder, Harm Reduction

Reports examine strategies for the treatment and management of substance use disorders

(September 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) has released a series of reports, in support of the U.S. Food and Drug Administration’s (FDA) ongoing efforts to develop strategies for the prevention, treatment, and management of substance use disorders. 

“A Practical Research Agenda for Treatment Development for Stimulant Use Disorder” emphasizes the need for continued investment in clinical research and for consensus around clinically meaningful and patient-centric endpoints for assessing treatments for stimulant use disorder. The report includes perspectives from across the health care spectrum, including experts from the patient community, academia, clinical care, pharmaceutical companies, payors, and the federal government. There are currently no effective pharmacological treatments for any type of stimulant use disorder. However, there are many opportunities to improve the study design of clinical trials for stimulant use disorder.  This report summarizes the discussions from a workshop the FDA Foundation hosted in collaboration with the FDA and the National Institute on Drug Abuse (NIDA).  

Two other reports, “Fentanyl Drug Checking and Screening: A Roundtable on Clinical Perspectives” and “Fentanyl Drug Checking and Screening: A Roundtable on Community Perspectives” provide key insights into the real-world challenges and opportunities for fentanyl drug checking and screening. They explore different perspectives from the harm reduction community on the use of fentanyl test strips and other drug checking methods. These reports detail the discussions from roundtables hosted by the FDA Foundation in partnership with the Behavioral Health Coordinating Council. The reports explore next steps for technology development, research, and practice related to Fentanyl drug testing.   

These reports are part of the FDA Foundation’s growing substance use disorder portfolio. The Foundation has published reports on payor perspectives of substance use treatment as well as individual and provider perspectives on medication for opioid use disorder. Those reports, and recordings of the Foundation’s public meetings on substance use disorders, are all available on the Foundation website.  

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

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