Student Scholarship

Document Type

Research Paper

Abstract

This research project, titled What Hath Goddard Wrought, examines the significant administrative and structural changes within the Food and Drug Administration (FDA) following the appointment of Dr. James L. Goddard as Commissioner in January 1966. The author contrasts Goddard's aggressive, science-oriented leadership style with the more informal, industry-friendly tenure of his predecessor, George P. Larrick. Under Goddard, the agency shifted its primary focus from traditional policing and food regulation toward sophisticated drug regulation and scientific research. 

A major portion of the study details the reorganization of the compliance bureaus and the decentralization of authority to eighteen district offices. This move aimed to reduce administrative layers and increase the autonomy of field offices in initiating legal actions, thereby speeding up the agency's response to public health hazards. However, the paper also highlights a critical failure in the reorganization of the Science Information Facility. This attempt to modernize data processing resulted in a loss of talented personnel and a near-total collapse of the facility's effectiveness due to mismanagement and internal power struggles. 

The analysis further explores the FDA's challenges in the legislative arena, specifically regarding the Child Safety Act of 1966. Despite the agency's goal to limit the quantity of children's aspirin per bottle to prevent accidental poisonings, powerful opposition from the pharmaceutical industry and poor presentation of statistics by the FDA led to a significantly weakened final bill. Ultimately, the project concludes that while Goddard successfully modernized the agency's institutional framework and emphasized sound scientific judgment, he struggled to reconcile the inherent conflict between the agency's roles as both a scientific research body and a regulatory police force.

Research Highlights

  • The Problem: The Food and Drug Administration (FDA) faced significant internal and external challenges during the transition from Commissioner George Larrick to Dr. James Goddard, including a need for organizational restructuring, increased scientific competence, and more rigorous enforcement of drug safety legislation. 

  • The Method: This research project utilizes interviews with FDA officials, legislative counsel, and industry representatives, supplemented by an analysis of secondary sources such as books, newspapers, and 1960s federal legislation including the Kefauver-Harris Amendments and the Drug Abuse Control Amendments. 

  • Quantitative Finding: In 1964, there were 26,000 cases of drug poisoning in children under five; nearly half involved aspirin overdoses resulting in 125 deaths; the FDA's 1966 budget exceeded $50 million and the agency employed approximately 4,000 people; the Bureau of Drug Abuse Control established nine field offices with 200 trained officers. 

  • Qualitative Finding: Dr. Goddard shifted the FDA toward a scientific research-oriented regulatory model while increasing district office autonomy; the reorganization of the Science Information Facility (SIF) resulted in a total loss of productivity and the departure of key technical personnel; the 1966 Child Safety Act was significantly weakened in Congress due to industry opposition and the FDA's failure to provide adequate statistical support during hearings. 

Publication Date

1-1967

Creative Commons License

Creative Commons Attribution-NonCommercial 4.0 International License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

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