Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. I will yield.

Mr. KENNEDY. Mr. President, I thank my friend from New Mexico. I had the good opportunity to attend that service as well. I will include my comments about Jack Valenti. He was a dear and valued friend of the Kennedys. We went back a long time with Jack, to the 1960 campaign. It was a long friendship, that endured a lot of very glorious times and difficult and challenging ones as well. He was a person of great purpose, with a love for his country, devotion to his industry, which he represented so effectively, and a wonderful friend to many of us. I thank the Senator for his comments. Mr. President, for the benefit of our Members here, we are going to recess shortly and go over to 9:30 tomorrow morning. The hour before the cloture vote will run from 9:30 to 10:30, and we will yield a half hour on our side to the proponent of the amendment, Senator Dorgan. Then at 10:30 or just about 10:30 we expect we will have a roll call vote on the Dorgan amendment, or the motion to invoke cloture on the Dorgan amendment. Then, depending on how that comes out, we will move ahead to hopefully conclude work on some of the items we have had good discussions about today--the Stabenow amendment. I am grateful to Senator Stabenow. We spoke about this earlier in the day. We have worked with her and made some very important progress and are grateful to her for her cooperation. We indicated now to the membership how we are going to proceed on the extremely important item of biologics. We now have the drug safety. We have enhanced this bill with food safety. We are going to address in our conference the issue of biologics. This is going to be an extremely important pathway. We have been working with Senator Roberts and Senator Harkin on the direct consumer advertising issue. There are some very important constitutional issues. I am grateful to Senator Roberts for his cooperation and help. Senator Kohl has an amendment on reverse payments. There is Senator Vitter's amendment and potentially one or two others that Members have indicated they are giving thought to offering, but haven't decided whether they would. We are getting close to the end of this, but we still have important matters to do. We are going to try to work with our colleagues. We have made great strides in the evenings. I am very grateful to Senator Enzi and particularly to our staffs who have, each evening, including through the weekend, worked tirelessly to try and ease the differences on many of these amendments and have done a brilliant job. This legislation is extraordinarily important. We have had several amendments, important amendments, but we have also worked out some others that have strengthened the legislation. In a few moments, we will go into adjournment until tomorrow. But Senators should look forward to the debate at 9:30 and vote at 10:30 on the cloture petition relative to the Dorgan amendment. I suggest the absence of a quorum.

Mr. KENNEDY. I ask unanimous consent that the order for the quorum call be rescinded.

Mr. KENNEDY. Mr. President, for the information of the Members, there will be no further votes this evening.

Mr. KENNEDY. If the Senator would withhold, we have a pending amendment. I will have to object until we clarify exactly where we are. Would the Senator give us 30 seconds?

Mr. KENNEDY. I have no objection to that.

Mr. KENNEDY. I thank the Senator for his cooperation. I suggest the absence of a quorum.

Mr. KENNEDY. I ask unanimous consent that his amendment be at the desk and be subject to being called up.

Mr. KENNEDY. That is exactly the purpose of the Foundation, which was included in the drug safety legislation Senator Enzi and I introduced last year. The Foundation will be financially supported by industry and philanthropic donated funds. A chief scientist at FDA will promote intramural research and coordinate it with efforts at the Foundation.

Mr. KENNEDY. Let me make absolutely clear that the Reagan-Udall Foundation will in no way override, overturn or conflict with the Dietary Supplement Health and Education Act. Nothing in this bill would have that effect.

Mr. KENNEDY. Yes, that is the case.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent that Thomas Kraus, an intern on my staff, be granted floor privileges for the remainder of the debate on the Food and Drug Administration Revitalization Act of 2007.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. KENNEDY. Mr. President, on behalf of the HELP Committee, I send to the desk a modification to the committee substitute.

Mr. KENNEDY. Mr. President, this basically incorporates a number of the adjustments and changes that we had indicated during the course of our markup. We had a number of amendments that were offered. We indicated to the members we would try to work through some of the points that were raised. I commend our staffs on both sides who have been diligent in doing so. These are alterations, changes that are known to the majority and the minority and all the staff members. Later on in the discussion and debate we can go into some in greater detail. Most of them are clarifications. Some of them are simplifications. I think all of them are worthy and justified, and I think they help to strengthen the legislation. So we are very grateful to all of our colleagues on our committee who offered the amendments, and, most particularly, we are very grateful for their willingness to work with us to try to work through these alterations and changes. Mr. President, this legislation, as was pointed out in the excellent statement made by our friend and colleague from Rhode Island, Mr. Reed, and others, is complex, but it is incredibly important in terms of American families, most precisely with regard to drug safety. We have reviewed those provisions. Senator Enzi made an excellent presentation yesterday. We tried to go through those in some detail yesterday afternoon. I might go through some of those again this afternoon. But we want our Members to know we are ready to consider amendments. We know there are several that are just about ready to be offered. We urge those who are considering bringing them to the floor, let's begin the debate and discussion. We have one or two that are still being worked on. So even though it does not appear like we are making progress on this legislation at the moment, progress is being made in making sure we are going to have strong FDA reauthorization legislation. But we do hope we can get to the amendments very soon, and we expect to be able to do so.

Mr. KENNEDY. Mr. President, I am pleased to continue working with my colleague from Kansas, Senator Roberts, and my colleague from Iowa, Senator Harkin, on the important issue of direct-to-consumer advertising. We have to strike an important balance between seeing that consumers get accurate information on drug safety and seeing that we do not improperly restrain free speech. Senator Harkin has a proposal to add safety information to drug ads. Senator Roberts has an idea to allow FDA to impose fines for inaccurate ads. Our bill includes a moratorium--only to be used in rare cases--on DTC ads. The IOM went further and recommended a moratorium on DTC for all new drugs. We rejected that recommendation due to the first amendment concerns but included more limited authority that we believe meets the constitutional test. Still, some have raised concerns about our current proposal, and we take those concerns seriously. We will continue to work on this important issue with our colleagues and constitutional experts. I think we are making progress through the afternoon and, hopefully, by tomorrow we will have some recommendation. I suggest the absence of a quorum.

Mr. KENNEDY

Mr. KENNEDY. Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. KENNEDY. I want to let our Members know about the substitute that has been included, that is before us now. It essentially clarifies the FDA's authority to place restrictions on drugs with safety problems; applies only to drugs like Thalidomide that could not otherwise be approved. We can understand why it is important that the FDA probably would not have approved Thalidomide, for all of the dangers it has, but it has now approved it to deal with some of the problems of leprosy. We want to make sure it is not going to be out there and be utilized in terms of expectant mothers. So we have worked this out. I thank Senator Coburn for his help on this issue. We also make sure the FDA takes into account concerns of rural communities in setting safety policies. We have given enhanced authority to the FDA in terms of safety policies. We want to make sure in the implementation of those, particularly in rural areas, they are not going to be so restrictive as to limit the opportunities to get the necessary prescription drugs. I thank Senator Harkin and Senator Murkowski, who were enormously helpful in working through that issue. This also adds a Web portal for FDA so consumers will have a single point of access, via the Internet, to drug safety information. I thank Senator Gregg for that. That will be very important for consumers who are concerned about the safety issues. All of those changes and alterations are very helpful and valuable in terms of the legislation itself. I wish to speak for 3 minutes as in morning business and not under the time on the bill.

Mr. KENNEDY

Mr. KENNEDY. Madam President, the President is going to be making up his mind on the issue of the supplemental and making a judgment in the next several hours. President Bush stubbornly clings to the false hope that success is just around the corner and that the mission will be accomplished. We have heard it all before. Ending the rule of Saddam Hussein was supposed to lessen violence and bring a new wave of democracy into the Middle East. It has not. Saddam Hussein's capture was supposed to quell the violence. It didn't. Free elections and the drafting of the constitution were supposed to be a breakthrough. They weren't. The surge was supposed to bring stability, essential to political reconciliation and economic reconstruction. It has not and it will not. Only the Iraqi people can save Iraq and it is time for them to do so. American military force cannot solve the problems of the Iraqi people. It is time for the President to put the Iraqis on notice that our military will begin to withdraw. No one in the administration can honestly tell the American people we are making progress in Iraq. It is time the President listened to the Iraq Study Group, Congress, and the American people, and work with us to bring our troops home. The President is wrong to veto the Iraq spending bill and reject its needed timeline for the orderly, responsible, and safe withdrawal of our forces from Iraq. He was wrong to lead us into the war, wrong to conduct it so poorly, and wrong to refuse to change course. We cannot continue business as usual in Iraq. It is time for America to end its participation in the brutal civil war. The message from the American people couldn't be louder or clearer: Instead of defying the will of the American people, President Bush should listen to their plea and begin working with Congress to bring this tragic war to an end.

Mr. KENNEDY. Madam President, as we know, the supplemental passed last Thursday. It is Tuesday today. So the comments I made were directed to the fact that the President has announced he is going to veto it. I just wanted to comment about that issue. Although we differ on that issue, we are together in wanting to get the Senate to both debate and dispose of amendments. The afternoon is moving along. We had statements yesterday from Senator Enzi and myself on this legislation, spelling this out. We had an opportunity in our caucus today--I imagine the Senator did as well--to go through the details of the legislation. So we have addressed many of the concerns. But there are still some concerns that are out there, and this is an extremely important piece of legislation. So we are asking our colleagues to come to the floor to let us know their amendments, to see if we can work those out. If not, we would like to have the debate on those measures and let the Senate exercise its will. We are ready for those amendments, and we urge our colleagues to bring them to our attention at the earliest possible time.

Mr. KENNEDY. Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. KENNEDY. Madam President, we are still looking for amendments. It is true that there are probably four important areas where negotiations are going on with the principals in a bipartisan way, and progress is being made. It does seem to us that we ought to continue that progress. We will describe in greater detail those procedures tomorrow. We are urging our colleagues who have amendments to get in touch with us. We know this is complex legislation, but it is enormously important, and we have a lot of business in the Senate. Our leaders have indicated that they wanted us to be ready to move ahead on amendments. Senator Enzi and I are quite prepared to do so. I understand the Senator from Michigan, Ms. Stabenow, has an amendment she is going to speak to and offer later on. We will look forward to her presence. We want to again underline the importance that if Members have amendments, notify us as soon as possible, so we can work on them and accept them if we can. We want to be able to conclude this legislation in a timely way in the not-too-distant future. I yield the floor.

Mr. KENNEDY. Mr. President, I would add a note of thanks to the Senator as well. We are strongly committed to information technology, the use of information technology eventually. We have that on our list. We passed it unanimously through this body a couple of years ago, but the House didn't act and we are going to act further. But what we are talking about in the database, which the Senator from New Hampshire talked about, is using the information technology and database in terms of the postmarketing or approval surveillance. This makes a great deal of sense. That is a key aspect of safety in the legislation. The Senator from New Hampshire is very interested in shaping that. The second is to make sure we are going to bring the latest information on drug safety to the consumers; that is more scattered at the present time than it should be. We have accepted the recommendation of Senator Gregg to include one what they call portal in the Internet to make sure that that information will be collected and available to the consumers on safety, which is a useful addition. So these are important. I thank him for his strong support for this legislation. This is very helpful. Now we are beginning to see, we have got broad support on our side and on both sides of the aisle for this legislation. We are working hard to clear up some of the--still a few of the outstanding items, but we are moving ahead. We want to indicate to our colleagues again that we want to try and respond to many of their amendments, but we want to do it in a timely way. We were in here yesterday afternoon with the presentation. We welcomed suggestions during the course of the evening last night, and we have done so during the course of the day. We are moving along we hope that anyone who has any other further amendments would be in close touch with us because we are giving every opportunity to our colleagues to make any recommendations they have or would like to move along to conclusion at a reasonably swift time. I yield the floor.

Mr. KENNEDY. Mr. President, I thank the Senator. We are reviewing the proposal. I understand the State of Louisiana has had a very strong regulatory process in terms of safety, which has been recognized and commended for some period of time.

Mr. KENNEDY. Mr. President, I thank the Senator. We are reviewing the proposal. We will work very closely with the Senator, and we will be back in touch making a recommendation, working with her. We thank the Senator very much.