Dan Coats: “I just urge--clearly, there is a differing point of view. We heard from Senator Dodd from Connecticut, who was involved…”

“I just urge--clearly, there is a differing point of view. We heard from Senator Dodd from Connecticut, who was involved in the drafting of the bill; and Senator Jeffords from Vermont, the committee chairman, explained this. This was someone who was directly involved in the 404 question and has been drafting the language and negotiating the language. This is clearly an issue we are going to have to address. The committee debated it. There has been negotiation subsequent to that. We are now in a position where we are going to have to agree to disagree. I just urge the Senator from Massachusetts, at the earliest possible time--I know it can't be done today given the problems we have with scheduling the Interior appropriations bill--to bring the amendment to the floor and then let us have the debate and then let the Senate work its will by vote and then go forward. Hopefully, this is not something that is going to further delay passage and then implementation of FDA reform. Every day we delay, many things happen, most of them bad. No. 1, we move ever closer to September 30, at which time the PDUFA, the drug prescription user fee which is used to provide the individuals with the resources necessary to expedite drug approval, expires.”