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 (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.
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