Drug Shortages: Causes, Current State and Path Forward

Track:
Pharmaceutical Quality

Day & Time:
June 26, 10:15AM - 11:45AM

Session Number:
339

Room Number:
153AB

Level:
Basic

Type:
Forum

Title:
Drug Shortages: Causes, Current State and Path Forward

Chair(s):
Marta E. Wosinska, PhD
Director for Economics Staff, Office of Planning and Analysis, CDER
FDA, United States

Description:
This forum will discuss the history and current state of drug shortages. It will primarily focus on the drivers and consequences of manufacturing quality problems for sterile injectable products.

Learning Objective(s):
Describe the history and current state of drug shortages; Explain the role played by manufacturing quality problems, the causes behind those problems, and the effectiveness and feasibility of various solutions.

Presentation(s) & Speaker(s):
Economic and Technological Drivers of Sterile Injectable Drug Shortages
Marta E. Wosinska, PhD
Director for Economics Staff, Office of Planning and Analysis, CDER
FDA, United States

Availability of Medicinal Products in the EU
Christa Wirthumer-Hoche, PhD
Deputy Head
Austrian Medicinal and Medical Device Agency (AGES), Austria

Current Trends in Drug Shortages
Erin Fox, PharmD
Director, Drug Information Service
University of Utah Hospitals and Clinics, United States