FREED of Opioids Act

3/13/2024, 5:16 PM

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.

The FREED of Opioids Act, also known as Bill 118 s 2737, is a piece of legislation currently being considered by the US Congress. The main goal of this bill is to address the opioid crisis in the United States by implementing various measures to combat the misuse and overprescription of opioids.

One key provision of the FREED of Opioids Act is the establishment of a national prescription drug monitoring program. This program would require healthcare providers to check a centralized database before prescribing opioids to ensure that patients are not receiving multiple prescriptions from different doctors, a practice known as "doctor shopping."

Additionally, the bill includes provisions to increase funding for addiction treatment and recovery programs, as well as for law enforcement efforts to combat the illegal distribution of opioids. It also aims to improve access to non-opioid pain management alternatives for patients. Overall, the FREED of Opioids Act seeks to address the opioid crisis from multiple angles, including prevention, treatment, and enforcement. Supporters of the bill argue that it is a comprehensive approach to tackling this complex issue, while critics may raise concerns about the potential impact on healthcare providers and patients.
Congress
118

Number
S - 2737

Introduced on
2023-09-07

# Amendments
0

Sponsors
+5

Cosponsors
+5

Variations and Revisions

9/7/2023

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

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.

The FREED of Opioids Act, also known as Bill 118 s 2737, is a piece of legislation currently being considered by the US Congress. The main goal of this bill is to address the opioid crisis in the United States by implementing various measures to combat the misuse and overprescription of opioids.

One key provision of the FREED of Opioids Act is the establishment of a national prescription drug monitoring program. This program would require healthcare providers to check a centralized database before prescribing opioids to ensure that patients are not receiving multiple prescriptions from different doctors, a practice known as "doctor shopping."

Additionally, the bill includes provisions to increase funding for addiction treatment and recovery programs, as well as for law enforcement efforts to combat the illegal distribution of opioids. It also aims to improve access to non-opioid pain management alternatives for patients. Overall, the FREED of Opioids Act seeks to address the opioid crisis from multiple angles, including prevention, treatment, and enforcement. Supporters of the bill argue that it is a comprehensive approach to tackling this complex issue, while critics may raise concerns about the potential impact on healthcare providers and patients.
Alternative Names
Official Title as IntroducedA 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.

Policy Areas
Health

Comments

Recent Activity

Latest Summary10/26/2023

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 ...


Latest Action9/7/2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.