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Essays on the development and FDA approval of pharmaceutical drugs
Ritzert, Angela Beth  Jensen, Richard E. 
Publisher:
ISBN10: 0599509856 ISBN13: 9780599509856

Summary

The research and development of increasingly more complex pharmaceutical products and therapies has dramatically impacted the lives of United States citizens in this century. In an attempt to analyze both the development and regulatory issues surrounding the pharmaceutical industry, this dissertation contains two essays with different focuses on pharmaceutical industry matters. The first essay examines the incentives surrounding the development and approval of drug products for rare diseases. The Orphan Drug Act of 1983 provided incentives to pharmaceutical companies, physicians, and academic researchers to develop treatments for those suffering from a rare, debilitating disease. In an attempt to address the issues of orphan drug development, a survey was sent to those pharmaceutical firms, biotechnology firms, physicians, and researchers who have filed with the Food and Drug Administration as having an orphan product designation. Survey responses received serve as the basis of the data set examining orphan treatment development. A combination of product-specific and sponsor-specific characteristics retrieved from survey respondents are used as explanatory factors in the estimation of two probit models, one model testing for effective incentives in orphan drug development, the other model testing for effective incentives in orphan drug approval. The second essay concerns itself with the factors affecting the regulatory review efficiency of Food and Drug Administration personnel by examining the length of regulatory review time, from submission of an NDA application until FDA approval for marketing, for new drug products. While most existing pharmaceutical industry literature focuses on firm decisions to invest in the drug research and development process, this essay examines the role of the FDA in helping to provide the public with drug products that are safe and effective. This study, using a data set consisting of 889 drugs submitted to, and approved by, the Food and Drug Administration between January 1, 1980 and June 30, 1995 is estimated using a hazard modeling approach. Hazard estimation allows for the prediction of the probability that the drug will be approved in the next moment conditional on time already spent under review, while also controlling for drug-specific and firm-specific effects on the regulatory review process.

Notes

Director: Richard A. Jensen. Thesis (Ph.D.)--University of Kentucky, 1999. Electronic reproduction.Ann Arbor, MI :ProQuest Information and Learning Company,2003.System requirements: Adobe Acrobat Reader.Available via World Wide Web.Digital version of: Essays on the development and FDA approval of pharmaceutical drugs.

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