Last week, the US Food and Drug Administration (FDA) approved aducanumab as a treatment for Alzheimer’s disease — a historic decision not because it addresses the longstanding need for a safe and effective cure of a devastating disease that affects nearly 6 million Americans, but because of the unprecedented irregularities of the agency’s actions, undermining its mission to protect public health and ensure the “safety, efficacy, and security” of treatments made available in the United States.
Last week, the US Food and Drug Administration (FDA) approved aducanumab as a treatment for Alzheimer’s disease — a historic decision not because it addresses the longstanding need for a safe and effective cure of a devastating disease that affects nearly 6 million Americans, but because of the unprecedented irregularities of the agency’s actions, undermining its mission to protect public health and ensure the “safety, efficacy, and security” of treatments made available in the United States.