A bill to require the Food and Drug Administration to determine whether to permit the use of enriched enrollment randomized withdrawal methodology with respect to clinical trials.
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.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 319.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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