This bill asks the FDA to study a specific way of testing whether opioid medications actually work for chronic pain patients. Right now, when drug companies test opioids, they use traditional methods. This bill wants the FDA to hire the National Academy of Sciences to research an alternative testing approach called "enriched enrollment randomized withdrawal," which is a different way of measuring whether these drugs are truly effective. After the study is done, the FDA would hold a meeting with its advisory committees to decide whether to allow drug companies to use this new testing method in the future. The committees would also look at whether the warning labels on currently approved opioid drugs need to be updated based on what they learn. Essentially, this is about potentially changing how the government evaluates whether new opioid painkillers actually work before approving them for patients.

FREED of Opioids Act

Manchin, Joe, III

FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials. Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain. The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study, vote on whether to permit the use of this methodology in drug clinical trials, and review the appropriateness of labeling on approved opioid drugs in relation to this methodology.