HHS · no agency ID · record R0840

Drug Shortage Predictive Model

Department of Health and Human Services · HHS/FDA/CDER

Overview

Development stage: PilotSource: b) Pilot – The use case has been deployed in a limited test or pilot capacity.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2024-05 (month precision)Source: May-24
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Forecasting and prediction, Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

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.

Expected benefits

Help with prevention and mitigation of drug shortages by signaling early risks to a supply chain, potentially ensuring patients maintain access to essential medications.

System outputs

Prediction of supply events for all CDER regulated application products in the next 12 months

Technology

AI classification: Classical / predictive MLSource: Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relatio…
System name(s): Not reported
Custom-developed code: Yes
Public source code: Not reported

Sourcing

How it was built: Developed in-houseSource: b) Developed in-house
Vendor (as reported): Not reported
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: No
Privacy Impact Assessment: Not reported
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: CDER data on submissions, drug shortages, compliance, reviews. External data on sales dollars and volume and product information.
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported