Social and Behavioral Sciences Commons^™

Correlations Between Management Behaviors And Financial Indicators With Fda Compliance Leading To Medicine Shortages, Francisco Gutierrez-Perez

Walden Dissertations and Doctoral Studies

In the first 3 years of the Obama Administration, 2009-2011, the number of warning letters issued to pharmaceutical firms for manufacturing and quality issues increased by 81% to 49 letters. Only 9 letters were issued in the last 3 years of the George W. Bush Administration. Shortfalls in compliance and product quality led to medicine shortages that affected patients' treatment and health. This quantitative study sought to learn to what extent, if any, the independent variables, management behaviors and financial indicators at pharmaceutical firms in the United States, correlated with, or predicted, the dependent variable, compliance with the FDA regulations. …