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Opioid Analytics Dashboard

Developing a dashboard for leadership to inform decision making.

Executive Summary

Prescription opioid analgesics, brand and generic, are important drugs used to manage pain. However, such drugs, although intended as analgesics, have a proven and growing propensity for abuse and misuse across the United States. In support of FDA’s mission to provide safe and effective drugs, along with its public health focus, it is critical that FDA look at its drug, manufacturing, and facility level data to support its emerging and revised opioids policies, as well as the cadre of stakeholder groups working on today’s opioid crisis throughout the agency. Currently, pockets of opioid data are collected, analyzed, and disseminated; however, CDER’s Office of Business Informatics is in a unique position to provide a comprehensive view of relevant opioid data. Such data can be used to support FDA’s regulatory review responsibilities from drug manufacturing (pre-market) to post-marketing activities allowing FDA to proactively track drug shortages of targeted opioid antidote drugs.

Team Members

Cheryl Ford (team lead), FDA
Hilmar Hamann, FDA
Gordon (Scott) Gideon, FDA

Milestones

October 2018: Project selected into the HHS Ignite Accelerator
March 2019: Time in Accelerator Began
June 2019: Time in Accelerator Ended