The United States is facing an overdose crisis. Over 107,000 Americans died of drug overdoses in 2021, according to the Centers for Disease Control and Prevention’s provisional estimates. According to the Department of Health and Human Services (HHS), the overdose crisis has evolved over time and is now largely characterized by deaths involving illicitly manufactured synthetic opioids, including fentanyl, and, increasingly, stimulants. Since 1999, the rate of overdose deaths has increased by more than 250%. In response to these changes, HHS launched its Overdose Prevention Strategy to focus on primary prevention, harm reduction, evidence-based treatment, and recovery support.
The Reagan-Udall Foundation for the FDA (FDA Foundation) supports the U.S. Food and Drug Administration’s work to develop strategies for the prevention, treatment, and management of substance use disorders by engaging with stakeholders in the health, regulatory, industry, caregiver and advocacy communities to identify and address critical gaps across the SUD treatment system.
The FDA Foundation, in collaboration with FDA and the National Institute on Drug Abuse (NIDA), hosted a virtual public workshop to discuss a practical research agenda toward treatment development for stimulant use disorder.
Meeting participants responded to a proposed practical research agenda that focuses on innovation in clinical trial design and candidate endpoints for the evaluation of potential treatments for stimulant use disorder.
Individuals inherently deserve services that promote health, regardless of whether they use drugs. Harm reduction is a set of proactive and evidence-based approaches that reduce the negative personal and public health impact associated with the use of alcohol and other drugs.
The FDA Foundation, working with FDA and several operating divisions within HHS, held two roundtables exploring community and clinical perspectives on fentanyl drug checking and screening. Community participants discussed their experiences using fentanyl test strips (FTS) and other drug checking methods, and clinician and researcher participants shared their perspectives on both clinical fentanyl testing and distribution of FTS to patients.
The FDA Foundation partnered with FDA’s Center for Drug Evaluation and Research to gain a deeper understanding of individuals’ experiences with substance use disorders (SUDs) – and specifically with SUD treatment. Our approach was to track individual treatment journeys to identify the specific challenges they faced and the supports they found helpful. Our goal is to use this ethnographic research to identify potential system improvements and engagement opportunities that can help inform FDA’s work in the prevention and treatment of SUDs. For this project, we looked at two specific issues: experiences exploring or using medication for opioid use disorder (MOUD), and trajectories of treatment for individuals who have pursued SUD treatment more than once.
Individuals exploring the use of medication to treat SUDs do not travel their paths alone. They are connected to networks of providers, peers, and family members who may have their own experiences, opinions, training, and expertise. Mapping individuals’ experiences led us to also map the experiences – and potential influences – of prescribing clinicians, non-prescribing clinicians such as counselors and therapists, and pharmacists. Individuals and these provider groups demonstrated generally positive views of MOUD and SUD treatment in general.
The Foundation teamed with FDA to host this virtual public meeting addressing some of the most frequently asked questions about access to naloxone, an antidote to opioid overdose.
Harm reduction specialists, physicians, pharmacists, and regulators explored the current landscape of naloxone availability, examined perceived barriers to naloxone access, and addressed questions posed by various groups on this subject. We then opened mics for nearly an hour of public comment to hear first hand from communities.
The FDA Foundation convened, in conjunction with FDA’s Center for Drug Evaluation and Research, a roundtable on “Payor Perspectives on Substance Use Disorder Treatment.” The purpose of the roundtable was to hear key stakeholders’ perspectives on health insurance coverage of pharmacological treatments for SUDs, including how FDA approvals and labeling affect payors and insurance coverage.
Patient advocates, clinicians, payors, health economists, and federal leaders all participated. Attendees discussed the data framework insurance companies utilize in making coverage decisions for patients receiving substance use disorder treatments. The convening additionally generated real-world insight into how regulatory decisions are applied in ways that impact people’s daily lives.