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Clinical Trial Transparency: The FDA Should and Can Do More

Published online by Cambridge University Press:  01 January 2021

Amy Kapczynski  and
Jeanie Kim
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Abstract

The Blueprint for Transparency at the FDA recommends that the FDA proactively release more clinical trial data. We show that the FDA possesses the legal authority to act on this recommendation, and describe several reasons that the agency should do so. In particular, the primary existing route for researchers to obtain access to this data, the Freedom of Information Act (FOIA), has important limits, as our own recent experience shows.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue S2: Symposium - Blueprint for Transparency at the U.S. Food and Drug Administration , Winter 2017 , pp. 33 - 38
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

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