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Opioid Efficacy Review: New Clinical Trial Rules

This act requires the Food and Drug Administration (FDA) to evaluate and decide whether to permit a new clinical trial methodology (EERW) for drugs, including opioids. This aims to ensure that marketed drugs are safe and effective, directly impacting citizens' health and safety, especially those with chronic pain.
Key points
The FDA must convene an expert meeting within 2 years to decide on permitting a new drug testing method.
These studies aim to better assess the efficacy of drugs, including opioids, used for chronic pain treatment.
An independent body (National Academy of Sciences) will conduct a study and submit a report on this methodology, ensuring an objective evaluation.
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Status:
Expired
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Additional Information
FREED of Opioids Act
Print number: S 1634
Sponsor: Sen. Manchin, Joe, III [D-WV]
Process start date: 2021-05-13
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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Summary & Status

Key Questions about Opioid Efficacy Review: New Clinical Trial Rules

A structured overview of the legislative process, official sources, status and civic context.

What is the official ID of this bill?

The official print number for this legislation is S 1634.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2021-05-13.

What are the main provisions?

Key points include:

  • The FDA must convene an expert meeting within 2 years to decide on permitting a new drug testing method.
  • These studies aim to better assess the efficacy of drugs, including opioids, used for chronic pain treatment.
  • An independent body (National Academy of Sciences) will conduct a study and submit a report on this methodology, ensuring an objective evaluation.

What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Manchin, Joe, III [D-WV].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-29.

Analysis and Potential Impact of S 1634

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

CATEGORIES

Health