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.
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 upon a determination that the drug does not provide a significant advantage or clinical superiority compared to other drugs.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.