Papers presented by Brice Bowrey since 2019

2022 Mexico City

"The Rise and Fall of Federal Regulation of the U.S. Medical Device Industry, 1960-2012"

Abstract:

Although the Federal Food, Drug, and Cosmetic Act gave the U.S. Food and Drug Administration (FDA) significant authority to regulate pharmaceuticals in 1938, the FDA was not granted substantial authority to regulate medical devices until 1976. This disparity and the subsequent shift in policy is a result of the unique economic and technological history of the medical device industry. Specifically, new technologies brought to market by medical device firms in the 1960s forced the courts to reconsider their definition and conception of medical devices. Later, once the FDA was granted the authority to regulate the industry, the vast number of small firms involved in the production of devices and the intimate relationships between medical experts and manufacturers stymied the FDA’s attempts to regulate the market. Considering these findings, this presentation proposes a four-phase interpretative framework of medical device regulation in late twentieth century America: In the first phase medical devices were largely unregulated. In the second phase the courts granted the FDA some authority to regulate devices, but the FDA did not fully exercise these powers. The third phase began with the passage of new legislation that failed to account for the brisk pace of innovation and rapidly changing structure of the nascent industry. The lack of support for this legislation within industry and the medical community precipitated the fourth phase, in which Congress deregulated the industry. This framework highlights the importance of industry-specific dynamics and technological innovation in the formation of regulatory regimes. It also strives to recognize the agency and influence of the regulators tasked with enforcing and interpreting the laws that bind businesses and shape markets.

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