118th Congress · SENATE BILLBILL

S. 2737FREED of Opioids Act

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.

Health
Introduced Sep 7, 2023
Last action Sep 7, 2023
Pipeline · Bill → Law
Step 1
Introduced
Sep 7, 2023
Step 2
Referred
Sep 7, 2023
HELP
Step 3
Committee
Step 4
Senate
Step 5
House floor
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS Summary

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...

Provisions · 2 sectionsIntroduced in Senate
Timeline · 2 actions
Sep 7, 2023
Introduced in Senate
Sep 7, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.