Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA’s Accelerated Approval Program

Publication Title

Journal of Law, Medicine & Ethics

Authors

Anjali D. Deshmukh, Georgia State College of LawFollow

Document Type

Article

Publication Date

2023

Abstract

In “Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency,” Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.

Recommended Citation

Anjali D. Deshmukh, Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA’s Accelerated Approval Program, 51 J.L. Med. & Ethics 920 (2023).

Institutional Repository Citation

Anjali D. Deshmukh, Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA’s Accelerated Approval Program, Faculty Publications By Year 3564 (2023)
https://readingroom.law.gsu.edu/faculty_pub/3564

Volume

51

First Page

920