There was no warning letter ever sent.

I would suggest to you that the jurisdictional question ought to be resolved very simply and starkly. If a company manufactures drugs, you regulate them now, do you not?

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I'm suggesting to you that the jurisdiction ought to be asserted as widely and effectively as possible and that there be no ambiguity in the law as there is now.

Your job--and it is uniquely and always the job of the Federal Government to establish standards that protect the public health and safety where there is a national impact.

Unfortunately, having reviewed many of these documents, having spoken to experts in the field, having reviewed the history here, the conclusion is inescapable that this tragedy could and should have been prevented by more effective…

I do think that we should know, and I would like to see that as part of new legislation if we would do it.

I think that a lot of the questioning that you're seeing here reflects a skepticism on the part of Congress and the public about whether the FDA will use this enhanced authority more effectively than it has used the authority that it has…

Those decisions that so swayed the FDA to avoid asserting its authority and jurisdiction were also unclear, limited, and contested.

I would just suggest that you be preventive with a capital P, and that you regard these renegade, outlier drug manufacturers as the threat to public health which, clearly, they are.

Thank you, Mr. Chairman. I'd like to pursue, Mr. Chairman, your questions at the very outset here about the Ameridose matter.

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So if I can sort of distill your answer into one sentence, the answer to the question depends on the plan document currently.

the expression of the community's intolerance for violence resulting from bigotry and bias and hatred is very much a proper and appropriate measure to take

So in effect, you're saying you don't have the authority that exists under the FDA Act that applies to a pharmaceutical drug manufacturer.

I think the reservation that you have expressed has been articulated, at least in my experience, in State legislatures when these issues arose.

I am sure that others have told you, you know yourselves, that service on the district court is crucially important to our justice system.

You will impact the lives, I would dare say, of more people directly than a lot of people in this body do.