Date of Conferral







Richard Schuttler


In the first 3 years of the Obama Administration, 2009â??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. FDA's enforcement actions on the firms were the treatment event. A shift in the relationship between the variables occurred after the FDA interventions, which highlighted a new level of compliance. Of the 1144 SurveyMonkey invitations sent to the members of the International Society of Pharmaceutical Engineers, only 21 completed the survey's 133 questions. Three research questions were addressed using correlations and linear regressions. The theory of planned behavior was applied to correlate behavioral constructs with the compliance of the firms leading to the rejection of the null hypothesis. By establishing an inverse relation between financial indicators and the firms' level of compliance, the study offers awareness and insight to senior leaders regarding their behaviors and the decision-making process. Enhancing managers' decision-making processes in light of their beliefs, along with their control over financial indicators, could reinforce the presence of effective quality systems among pharmaceutical manufacturers minimizing medicine shortages.