Drug Shortage Predictive Model
Description
Drug shortages have increased significantly since 2017 and worsened during COVID-19, creating critical gaps in patient access to essential medications. FDA seeks to develop predictive capabilities to anticipate shortages before they occur.
Detailed example
Prediction of supply events for all CDER regulated application products in the next 12 months
AI / analytics pattern
Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.
Automation level / stage
b) Pilot – The use case has been deployed in a limited test or pilot capacity.
Expected benefit
Help with prevention and mitigation of drug shortages by signaling early risks to a supply chain, potentially ensuring patients maintain access to essential medications.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
CDER data on submissions, drug shortages, compliance, reviews. External data on sales dollars and volume and product information.