ABSTRACT

 Impact of User Fees on Changes within the
Food and Drug Administration (FDA)

 By Gary W. Lawson, DPA

 University of La Verne: 2005

Purpose: In 1992, Congress authorized the Food and Drug Administration (FDA) to collect funds directly from the brand name drug manufacturers.  In relation to the FDA’s primary mission of protecting and safeguarding U.S. citizens, the purpose of this study was to help interested parties better understand the impact of brand name drug industry fees paid directly to the FDA.

Theoretical Framework: The theoretical framework for this study was based on the public choice theory genre. Regulators (ie. FDA) receiving significant funds from organizations they regulate (ie. brand name drug companies) caused a shift in the principal-agent which over time progressed into the capture theory.

Methodology: The study used a research model based on eleven research questions.  Secondary data sources and descriptive statistics methodologies were used.

Findings and Conclusion: User fees paid directly to the FDA has made the FDA’s motives suspect. It is no longer clear whether the FDA is basing its brand name drug industry decisions on financial rather than safety, efficacy and humanitarian considerations. Four major findings were established: (1) continuation of user fees impedes the FDA’s ability to maintain the public trust: (2) public agencies are held to a higher moral, legal and ethical standard; (3) to secure the continuation of user fees, the FDA has made a dramatic shift that protects the drug industry and puts U.S. citizens at risk; and (4) to best protect the public and to ensure the public trust, the FDA needs a better system of checks and balances.

Recommendations: This funding method needs to be eliminated or changed to eliminate the potential for a Agency conflict-of-interest, and an FDA objective system of checks and balances needs to be initiated which includes but is not limited to creating an independent, post-marketing drug safety office.

© 2005 Gary W. Lawson, Ph.D., DPA.  Do not reproduce without permission.  **Note: The information, opinions and points of view expressed on this website are those of Gary W. Lawson, Ph.D., DPA, only. The content of this website is not meant to represent the opinion of any other organization, entity or individual.