arrow_back Back to App

New Opioid Drug Approval Rules: Enhanced Patient Safety.

This bill aims to enhance patient safety by allowing the drug approval agency to reject new opioid drugs if they do not offer a significant advantage over existing ones. This means only drugs that genuinely improve treatment or are safer will reach the market, potentially reducing addiction and overdose risks.
Key points
The drug approval agency can reject new opioid drugs if they are not superior to existing ones.
The goal is to ensure new opioid drugs offer real benefits in terms of safety or effectiveness.
This could limit the availability of opioid drugs that offer no new benefits, potentially reducing misuse risks.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 118_HR_1375
Sponsor: Rep. Trone, David J. [D-MD-6]
Process start date: 2023-03-03
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

EFFECTIVE Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_HR_1375.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2023-03-03.

What are the main provisions?

Key points include:

  • The drug approval agency can reject new opioid drugs if they are not superior to existing ones.
  • The goal is to ensure new opioid drugs offer real benefits in terms of safety or effectiveness.
  • This could limit the availability of opioid drugs that offer no new benefits, potentially reducing misuse risks.
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 Rep. Trone, David J. [D-MD-6].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-24.

CATEGORIES

Health