EFFECTIVE Act

3/13/2024, 11:23 AM

Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act

This bill specifies that the Food and Drug Administration may deny an application for a new opioid analgesic drug (i.e., opioid medication) upon a determination that the drug does not provide a significant advantage with respect to safety or effectiveness as compared to other drugs.

Congress
118
Number
S - 607
Introduced on
2023-03-01
# Amendments
0
Sponsors
+5
Cosponsors
+5

Variations and Revisions

3/1/2023
Text
PDF
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Status of Legislation

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

Purpose and Summary

Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act

This bill specifies that the Food and Drug Administration may deny an application for a new opioid analgesic drug (i.e., opioid medication) upon a determination that the drug does not provide a significant advantage with respect to safety or effectiveness as compared to other drugs.

Alternative Names
Official Title as IntroducedA bill to allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs.
Policy Areas
Health

Comments

Related

Bill Update Alert:  EFFECTIVE Act

Recent Activity

Latest Summary7/20/2023

Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act

This bill specifies that the Food and Drug Administration may deny an application for a new opioid analgesic drug (i.e.,...

Latest Action3/1/2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.