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Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA's

Anjali D Deshmukh1

  • 1GEORGIA STATE UNIVERSITY, ATLANTA, GA, USA.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|March 13, 2024
PubMed
Summary

Agency capture and political influence delay confirmatory trials for accelerated approval drugs. Dr. Herder proposes solutions but calls for more evidence and consideration of institutional limits for the US Food and Drug Administration (FDA).

Keywords:
Accelerated ApprovalDrug RegulationFood and Drug AdministrationNon-Delegation

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Area of Science:

  • Health Policy
  • Regulatory Science
  • Pharmaceutical Policy

Background:

  • The US Food and Drug Administration (FDA) faces scrutiny over drug approval processes.
  • The accelerated approval pathway allows earlier drug access but necessitates post-market confirmatory trials.
  • Concerns exist regarding potential agency capture and political influence on regulatory decisions.

Purpose of the Study:

  • To analyze the factors contributing to delays in confirmatory trials for accelerated approval drugs.
  • To examine the role of agency capture and politicized discretion within the FDA.
  • To propose solutions for improving the efficiency and integrity of the accelerated approval process.

Main Methods:

  • Qualitative analysis of the "Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency" paper.
  • Review of a three-drug case study.
  • Incorporation of insights from interviews with twenty-three unnamed FDA officials.

Main Results:

  • Agency capture and politicized discretion are identified as key drivers of delays in confirmatory trials.
  • The study highlights broader concerns regarding the FDA's internal workings and decision-making processes.
  • Two innovative policy solutions are proposed to address these issues.

Conclusions:

  • Dr. Herder's analysis provides nuanced insight into FDA operations and the challenges of the accelerated approval pathway.
  • The proposed solutions require further corroborative evidence and careful consideration of institutional and constitutional constraints.
  • Balancing agency expertise, data-driven decisions, and delegation remains a critical challenge in pharmaceutical regulation.