This bill is really about real people who have been let down--let down, sometimes catastrophically.
I must also say, regardless of the difference between drugs and devices, we're getting new drugs on the market all the t...
I happen to be for innovation, I happen to be for new devices, I happen to think that these are good things, but I also ...
If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and...
But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'
I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy.
Well, the ultimate goal is to get the very best devices we can to really help people like Mr. Mulvihill, like Mr. Roman,...
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 t...
I think sometimes they do good things, other times they don't do what they should be doing.
Manufacturers who commit fraud on the FDA are not immune from lawsuits.
They could penalize the company. They could seize the offending illegal products.
So, it doesn't go right back and go through the whole process again.
I was just reminded by my staff that we change drugs all the time for kids--change them all the time--for dosages and re...
I don't know where they'd get the money to hire these high-price lawyers from these big law firms.
FDA needs adequate appropriations.
Before Riegel was decided, the device manufacturers were subject to tort laws.
So, the way I see it--before Riegel, the device manufacturers didn't know if they'd win or lose in a tort claim, right?
To me, that choice is clear. We need safe products and we need innovation, and the best way to achieve both goals is not...
