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FDA Opioid Systems Modeling Effort

In response to recommendations from the National Academies of Sciences, Engineering and Medicine (NASEM) in 2017, FDA is undertaking efforts to incorporate a systems approach into considerations about the public health impacts of the opioid crisis. In collaboration with external experts, FDA has developed a national-level system dynamics model of the opioid crisis, called SOURCE (Simulation of Opioid Use, Response, Consequences, and Effects). The primary objectives of the model are threefold: help FDA and other stakeholders identify high-impact opioid-related 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 opioid, modeling, policy, and implementation experts. FDA is also working to incorporate a supporting analysis service to facilitate engagement with SOURCE by FDA decision-makers. The support service also aims to leverage complementary qualitative and quantitative modeling approaches as part of the toolkit of resources informing FDA’s policy assessments.

Introduction to the Modeling Effort

  • In March 2021, 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, and highlights preliminary areas for potential policy analyses. More updated information about the SOURCE model can be found in the publications linked below. | White paper, March 2021
  • FDA also prepared a one-page overview describing the project. | One-pager, June 2022 (PDF - 81 KB)

More about the SOURCE Model

FDA’s collaboration with external experts has resulted in publications that describe the model and exploratory analyses.

  • “Modeling the evolution of the US opioid crisis for national policy development” by Lim, et al. published in Proceedings of the National Academy of Sciences in May 2022. The paper describes the SOURCE model and its baseline projections of the opioid crisis, should no interventions occur. | Publication, May 2022
  • “Reducing Opioid Use Disorder and Overdose Deaths in the United States: A Dynamic Modeling Analysis” by Stringfellow, et al. published in Science Advances in June 2022. The paper presents the first analysis from SOURCE, which explores the future impacts of 11 broad hypothetical strategies spanning opioid misuse and opioid use disorder prevention, harm reduction, buprenorphine treatment, and recover support for people in remission. | Publication, June 2022

The SOURCE model, along with all supporting data and documentation, is available for public use on GitHub. | Link

Parallel Modeling Efforts within the Department of 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).

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

Partnerships with Other Institutions in Support of Model Development and Use

  • Harvard Medical School / Massachusetts General Hospital leads the model development and enhancement effort, via a Collaborative Agreement with FDA (2019 – present). | Harvard’s project homepage
  • Booz Allen Hamilton supported model validation, maintenance and implementation of the model as a policy analysis tool and service (2019 – 2022).
  • The University of Maryland Center for Excellence in Regulatory Science and Innovation (CERSI) is currently conducting research on the utilization of treatment for opioid use disorder and the role of this treatment in the opioid system. The research is intended to support better incorporation of treatments for opioids use disorder into systems modeling (2020 – present). | University of Maryland’s project homepage
  • The Yale University/Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) is currently conducting research on factors that influence healthcare provider decisions regarding the prescribing of opioid analgesics. This research is intended to support better incorporation of influences on prescribers into systems modeling (2021 – present). | Yale University/Mayo Clinic project homepage
 
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