Tom Harkin

I beg you to look at ways that we can afford intensive behavioral therapy for all children.

I ask that you particularly look at this, particularly when you're confirming a new NIH director.

Can we afford not to put the money into research and treatment if these are the numbers that we're looking at?

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.

The problem is, we don't know. We don't know if 29 vaccinations--immunizations--by the age of 2 do have an effect.

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 given together, a lot of times, before the age of 2.

The vaccines that were there then that we're using now are----

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 of vaccines, because they're all getting the same number, before the age of 2?

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 you start that?

So, your group, this interagency group, is actively out there looking at different interventions and trying to find out which ones work best and--are you also promoting different types of--in other words, are you instigating different…

Our interest, obviously, is in research and finding causes, which hopefully will lead to prevention and cures.

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.

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 happen to be for innovation, I happen to be for new devices, I happen to think that these are good things, but I also believe in holding people accountable unto the strictest standards of safety and manufacture.

They could penalize the company. They could seize the offending illegal products.

Manufacturers who commit fraud on the FDA are not immune from lawsuits.

I must also say, regardless of the difference between drugs and devices, we're getting new drugs on the market all the time, and they are not preempted from tort claims.

Before Riegel was decided, the device manufacturers were subject to tort laws.

I think sometimes they do good things, other times they don't do what they should be doing.

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've got to be helped.

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 to get at these documents, then you will never know whether or not they committed fraud on the FDA…

The FDA does not have subpoena power, does it?

So, it doesn't go right back and go through the whole process again.