On the recordSeptember 23, 1997
I concur with the Senator's notion that the FDA could look at safety and effectiveness but the critical question is safety and effectiveness to do what? To do what the labeled use is or to do something else. And the language of the bill restricts the answer to that question, to do what, statutorily to simply say whatever the company puts into the label. And that seems to be the crux of this debate. Yes, they can look at safety and effectiveness; yes, they can look at technological change, but only in the context of what the company purports in the label to say is the intended use. They can't look beyond it.
Source
govinfo.gov
