I ask that you particularly look at this, particularly when you're confirming a new NIH director.
Well, thank you very much, Dr. Insel.
Well, that is true. And that is why I say--we have got to do both--the research on the causes and the triggers, but also interventions.
Yes, I get confused when we get into this area, because I just wanted to focus on the number of vaccines, and the fact that they're all give...
Well, I guess what I don't understand is how you can have a study involving hundreds of thousands of children and all with the same number o...
What do we know works for treating autism--we talked about this applied behavior therapy, seems to be successful. But, how early an age can ...
Our interest, obviously, is in research and finding causes, which hopefully will lead to prevention and cures.
So, why are medical devices different than drugs?
You're saying that a device manufacturer, like this Medtronic defibrillator, when it went through the whole premarket approval and everythin...
Do I want safe products? Absolutely. For me, the question is who decides.
I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy.
But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'
I was just reminded by my staff that we change drugs all the time for kids--change them all the time--for dosages and recommended treatments...
So, it doesn't go right back and go through the whole process again.
To me, that choice is clear. We need safe products and we need innovation, and the best way to achieve both goals is not through litigation ...
If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and can't get discovery...
We should give them the resources. We've asked them to do a myriad of things, and yet we don't give them the resources to carry it out.
FDA needs adequate appropriations.
