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Toward a Jurisprudence of Drug Regulation

Published online by Cambridge University Press:  01 January 2021

Matthew Herder
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Efforts to ensure greater transparency in the regulation of “drugs” (used here as a catch-all for pharmaceuticals, biologics, medical devices, and biomarker-based technologies such as genetic testing paired with a pharmaceutical or biologic) are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) —should also be open to outside scrutiny provided they are final in nature.

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Journal of Law, Medicine & Ethics , Volume 42 , Issue 2 , Summer 2014 , pp. 244 - 262
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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References

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