Political Quotes

“let me say how proud I am of all of the members of the HELP Committee on this difficult and complicated issue they are bringing before us. Having been in business and under the control of the FDA as a medical device manufacturer, this is a very complicated area of law that, if done right, will have tremendous positive effects, and I think the Senators have put out a very good bill. I congratulate my colleagues and all the members on doing that. I have two amendments, and I am going to speak for a very short period of time on both of them. I will work with the ranking member and the chairman to see if we can't get to where we don't have to vote on them. I would like to give just a little history on PDUFA and MDUFA. The reason they were set up in the first place was to help fund the FDA, and the reason the manufacturers agreed to do that was to get more timeliness in terms of response to their applications. That was the whole basis for it. And what we have before us today is some improvement in terms of the FDA's response but really not everything we should have gotten. I, along with Senator Burr, asked for a GAO study to the FDA in terms of meeting stated performance goals, and we found out a whole lot about that, and that is my next amendment, but I say that to preface why I have this amendment.…”