Testimony of Diana Zuckerman at the FDA Advisory Committee Meeting on Extended-Release/Long-Acting Opioid Analgesics Post-marketing Requirements

April 19, 2023: FDA has worked with industry to propose a clinical trial to determine safety and efficacy of extended release (ERLA) opioids for chronic pain. We criticized the proposed study due to bias, poor study design, and ethical considerations for patients who could be harmed by the study. We urge the FDA to revise the labels to restrict the use of these opioids for chronic pain, based on current data and not wait for what could be an inevitably flawed study to be completed.

Read More »