When Biomarkers Are Not Enough: FDA Evaluation of Effectiveness of Neuropsychiatric Devices for Disorders of Consciousness

34 Pages Posted: 16 Oct 2018

See all articles by Megan S. Wright

Megan S. Wright

The Pennsylvania State University (University Park) – Penn State Law

Keturah James

Yale University, Law School, Students

Adam Pan

Yale University, Law School, Students

Joseph Fins

Weill Cornell Medical College

Date Written: September 23, 2018

Abstract

Studies demonstrating the efficacy of interventions for neuropsychiatric disorders often rely on the assessment of a trained observer or patient reports, evidence that can be more subjective than biomarkers. The problem with relying upon subjective evidence of efficacy is that objective evidence is advantaged in the medical product approval process, notwithstanding the increase in submission of patient-reported outcomes in applications to the U.S. Food and Drug Administration (FDA). The FDA’s preference for biomarkers may thus adversely impact the approval process for interventions targeting neuropsychiatric conditions, for which there are no biomarkers or only emerging biomarkers (with limited sensitivity or specificity) associated with the disorders.

In this Article, we first review how the FDA evaluates different types of evidence of an intervention’s efficacy, focusing on Class III medical devices. We use the case of disorders of consciousness to analyze relevant regulations and guidance for the development of novel neurotechnologies when subjective data is used in an approval process. We then offer suggestions for reform, arguing for a more expansive approach to what constitutes evidence of efficacy en route to more objective and vetted biomarkers. Specifically, we argue that patient- provided information is valuable and should be included in applications to the FDA, yielding a more integrated and holistic approach, or what some scholars refer to as a “pluralistic way of knowing.” We also argue for greater transparency from the FDA about how patient-provided information is evaluated, valued, and weight as part of the application for approval of new drugs and devices. While our Article focuses on disorders of consciousness and neurotechnology, our arguments have broader implications for the evaluation of emerging drugs and devices designed to ameliorate other neuropsychiatric conditions where the subjective experience of patients has particular relevance.

Keywords: FDA, medical devices, neurotechnology, neuroethics, disorders of consciousness, biomarkers

Suggested Citation

Wright, Megan and James, Keturah and Pan, Adam and Fins, Joseph, When Biomarkers Are Not Enough: FDA Evaluation of Effectiveness of Neuropsychiatric Devices for Disorders of Consciousness (September 23, 2018). Stanford Technology Law Review, Vol. 21, No. 2, 2018, Available at SSRN: https://ssrn.com/abstract=3253927

Megan Wright (Contact Author)

The Pennsylvania State University (University Park) – Penn State Law ( email )

Lewis Katz Building
University Park, PA 16802
United States

Keturah James

Yale University, Law School, Students ( email )

127 Wall Street
New Haven, CT 06511
United States

Adam Pan

Yale University, Law School, Students ( email )

127 Wall Street
New Haven, CT 06511
United States

Joseph Fins

Weill Cornell Medical College ( email )

1300 York Avenue
New York, NY 10065
United States

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