In response to recommendations from the National Academies of Sciences, Engineering and Medicine (NASEM), FDA is developing a national-level system dynamics model of the opioid crisis, with the goal of informing potential regulatory actions that may make meaningful gains in addressing the crisis. The primary objectives of the model are threefold: help FDA and other stakeholders identify high-impact interventions, assess potential unanticipated consequences of potential policies, and identify needs for further research. Model development began in 2018 and has involved a strong collaboration of opioids, modeling, policy, and implementation experts. To date, this effort has resulted in development of an initial model and a framework for its use in policy analysis. Continued efforts will further enhance the model, implement a policy analysis service and disseminate findings.

Introduction to the Modeling Effort

• FDA prepared a white paper that introduces FDA’s opioid systems modeling effort, discusses potential uses of the model, provides an overview of the model’s scope and structure, highlights preliminary areas for potential policy analysis and outlines on-going work. | White paper, March 2021
• FDA also prepared a one-page overview describing the project. | One-pager

Parallel Efforts within Health and Human Services

FDA’s systems modeling initiative coincides with complementary research and modeling efforts undertaken by HHS partners at the National Institute on Drug Abuse (NIDA) and the Centers for Disease Control and Prevention (CDC). The models under development by FDA, NIDA, and CDC apply different modeling scopes and strategies (e.g., agent-based modeling and compartmental models) to provide unique insights that complement one another.

FDA hosted two meetings to bring together the HHS modeling teams and other modeling, data, and opioids experts.

• Data Needs in Opioid Systems Modeling: An HHS Interagency Collaboration (April 29, 2019) | Meeting summary article
• Assessing and Incorporating Intervention Effectiveness in Systems Models of the Opioid Crisis (October 20-22, 2020) | Duke Margolis meeting homepage

Collaboration with Other Partners

• As of 2019, a team at Harvard Medical School / Massachusetts General Hospital leads model development, via a Collaborative Agreement with FDA. | Harvard’s project homepage
• As of 2019, a team from Booz Allen Hamilton is supporting implementation of the opioid systems model as a policy and research tool for FDA.
• As of 2020, FDA and a team at University of Maryland are exploring available data to increase understanding of treatment trajectories for people with opioid use disorder.