TABLE OF
CONTENTS
ABSTRACT…
LIST OF TABLES..
LIST OF FIGURES….
ACKNOWLEDGEMENTS…
DEDICATION….
Chapter I. GENERAL PROBLEM
Introduction…. Background of the Problem… Problem Statement… Purpose of the
Study… Research Questions… List of Acronyms…Limitations of the Study… Significance
of the Study… Public Administration Problem… Six Ways to View the Public
Administration Problem… Efficiency vs.
Effectiveness… Responsibility… Legitimacy… Accountability… Representation… Politics/Administration Dichotomy…Chapter I Summary
Chapter
II. LITERATURE REVIEW
Introduction…Food and Drug Administration (FDA)…FDA’s Origins…FDA
Responsibilities…Modern FDA…History of Federal Drug Regulation
1902-Present…Biologics Act of 1902…Pure Food and Drugs Act of 1906…Harrison
Narcotics Act of 1914…Food, Drug and Cosmetic Act of 1938…Durham-Humphrey
Amendment 1951…Kefauver-Harris Amendment of 1962…Orphan Drug Act of
1983…Waxman-Hatch Act of 1984…The Federal Technology Transfer Act of
1986… Prescription Drug User Fee Act (PDUFA) 1992…The Uruguay Round Agreements
Act of 1994… FDA Modernization Act of 1997 (FDAMA) (aka PDUFA II)….PDUFA
III—2002…User Fees...User Fees General Information…. User Fees—Differences
Between Regulatory and Non-regulatory...Pro User Fees—FDA….Con User
Fees—FDA… Drug Testing…Step I—Preclinical Testing…Step II—New Drug Application (NDA)—Phase
I Clinical Trials...Phase II Clinical Trials...Phase III Clinical Trials…NDA
Review... Monitoring Drug Safety After FDA Approval... Brand-Name
Pharmaceutical Industry...History... Drug Costs... Drug Industry Profits...Drug
Industry Advertising... Advertising vs. R&D... Research and
Development (R&D)...Tax Breaks and Tax Credits...Patent Issues (Pharmaceutical
Monopoly)....Political Lobbying...Drug Safety Issues...Conflict of
Interest—FDA...Comparison of FDA to FAA... Ethics…Conclusion
Chapter III. THEORETICAL CONSIDERATIONS
Introduction...FDA General
Information...Theoretical Considerations to Explain FDA Changes Within the FDA
Since User Fees...Altering Principal-Agent Relationship...Capture
Theory...Unmasking Administrative Evil...Ethics...Conflict of Interest General
Information....Conflict of Interest Legislation...Bribery...Illegal
Gratuities...Unauthorized Compensation... Acts Affecting Financial
Interest...Post-employment Activities...Outside Salary of Federal
Employees...Research Model Based on Theory...Conclusion...Main Findings From the
Theoretical Review
Chapter IV.
RESEARCH METHODOLOGY
Introduction...Research
Questions...Baseline...Efficiency...Cost Shifting...FDA Function and Priority
Shift… Effectiveness
Chapter V. RESEARCH
RESULTS
User Fees' Significance to FDA Drug Approval
Process…Interpretation and Discussion...Efficiency—NDA Approvals...
Drug Review and Approval Time...Percentage of New Drug Approvals...New Drugs
Introduced in U.S. First... Medication Costs...Interpretation
and Discussion...FDA Organizational Changes Since User Fees...FDA Function and
Priority Shift...FDA Budgetary Shifts...NDA Priority vs. Standard Reviews...NDA
Division Workload Changes...Effectiveness—Consumer Safety...Reporting Adverse
Drug Reactions...NME Safety Related Withdraws...Limitations of Study…Suggestions
for Further Research…Chapter Summary…
Chapter VI. CONCLUSION
Research Results…Major Findings…Loss of
Public Trust...Public Agencies Held to a Higher Standard…Since User Fees, FDA
Has Shifted...Checks and Balances…Consumer Drug Protection Agency (CPDA)...Chapter
Summary
REFERENCE LIST
|