Tom Harkin actually said...

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.

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...

Well, the ultimate goal is to get the very best devices we can to really help people like Mr. Mulvihill, like Mr. Roman, in ways that they'v...