Accelerated Drug Approval Program Holds Potential for Neurology Patients, New Paper Explains

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Clinical Neurological Society of America

Mar 01, 2023, 11:11 ET

Clinical awareness paper details the program's history and debunks popular misconceptions

TALLAHASSEE, Fla., March 1, 2023 /PRNewswire/ -- A new white paper from the Clinical Neurological Society of America explains how misconceptions about the FDA's Accelerated Drug Approval Program could undermine patients' timely access to novel medications – and why collaboration and greater awareness are necessary. The paper offers an overview of the program and its potential benefit to neurology patients, as well as insights on common myths and access challenges.

Dispelling Myths and Addressing Clinicians Concerns

In a recent survey of neurology clinicians, the Clinical Neurological Society of America found broad acceptance and support for accelerated approval, but also identified misconceptions. About one in four surveyed clinicians expressed reservations about the safety of drugs approved through the program and the extent to which the FDA balances safety and speed.

Considering those findings, the white paper highlights the many steps in place to ensure the safety of medications that undergo accelerated approval. The paper also outlines access challenges that patients who need accelerated approval medications may face. These include coverage barriers, high out-of-pocket costs and Medicaid coverage issues.

The paper calls for greater awareness and collaboration across stakeholders to help close the knowledge gap and improve access to treatment for neurology patients who stand to benefit from accelerated approval drugs.

About the FDA's Accelerated Drug Approval Program

The FDA's Accelerated Drug Approval Program can cut years off the traditional review timeline for medications that fill an unmet need for patients with serious or rare diseases that often have no other treatment. To expedite the approval process, these medications' efficacy is demonstrated by a surrogate endpoint – like the ability to shrink a tumor – as opposed to a clinical outcome. After approval, manufacturers are required to conduct confirmatory clinical trials to verify the indicated clinical benefits.

Learn more in "Accelerated Drug Approval: History, Misconceptions & Potential for Neurology Patients."

STATEMENT FROM DAVID CHARLES, MD, CNSA CLINICAL AWARENESS INITIATIVE PROJECT ADVISOR:
"Given the recent public interest and neurology clinicians' concerns about the FDA's Accelerated Approval Program, this paper offers an important reminder that collaboration among clinicians, policymakers and other stakeholders can increase awareness, combat myths and strengthen the program, particularly for patients living with debilitating neurological conditions."

The Clinical Neurological Society of America, a non-profit 501(c)(6), is a nationwide organization of neurology clinicians with a mission to improve clinical practice and patient care through education.

SOURCE Clinical Neurological Society of America