William H. Frist said "The amendment is unnecessary. The amendment we are going to be voting on right now is unnecessary, and a little bit worrisome because if it were to pass, there is a possibility that we hurt the system. In other words, we disallow improved devices which can benefit heart disease or lung disease, we put up barriers and push them off into the future. So if the amendment passes, it may be harmful. It clearly is unnecessary today. The bottom line is this. The Food and Drug Administration is required to deny premarket approval for a device if the proposed label is false or misleading--current law--and that is why it is unnecessary." @ PoliticalQuotes.com

On the recordSeptember 23, 1997

The amendment is unnecessary. The amendment we are going to be voting on right now is unnecessary, and a little bit worrisome because if it were to pass, there is a possibility that we hurt the system. In other words, we disallow improved devices which can benefit heart disease or lung disease, we put up barriers and push them off into the future. So if the amendment passes, it may be harmful. It clearly is unnecessary today. The bottom line is this. The Food and Drug Administration is required to deny premarket approval for a device if the proposed label is false or misleading--current law--and that is why it is unnecessary.

Said by

William H. Frist

Tennessee

Source

govinfo.gov

Editor's note · Context

Discussing an amendment related to FDA regulations during Senate floor debate.

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