Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I understand there is a time allocation; am I correct?

Mr. KENNEDY. Could the President tell us the time allocation remaining?

Mr. KENNEDY. I note that the Senator from Maine was on the floor before I came down, and I know there are other Senators, Senator Roberts being one, who wanted to speak, and I think Senator Burr. We also have a number on our side. My ranking member is here, and I imagine he will allocate the time on his side. I am glad to have the good Senator from Maine go ahead. I understand there are 9 minutes in total on her side. Mr. President, I ask unanimous consent that I be allowed to follow her.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, we will speak as in morning business for 10 minutes and if the Chair would let me know when I have a minute left.

Mr. KENNEDY. Mr. President, could I have the attention of Members. I understand the good Senator from Kansas wanted to make a brief statement about the terrible tragedies that have affected his State, and I see my friend from Vermont is here, so if he were to take 10 minutes, we would still have 10 minutes.

Mr. KENNEDY. I am wondering if Senator Sanders would be willing to take 6 minutes and let Senator Roberts have 4 to talk about the tragedies in his State. He mentioned this earlier to me, and I didn't think we would have this time dilemma. Would that be acceptable?

Mr. KENNEDY. We have the whole 30 minutes, but the Senator from Vermont has said that, of his 10 minutes, he would be glad to yield to you 4 minutes, and then he will take 6 minutes. Would that be agreeable?

Mr. KENNEDY. Mr. President, I will yield 1 minute of my time to Senator Sanders.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, hopefully during this afternoon we will have a chance to move irrevocably toward bringing the FDA into the 21st century, in terms of safety and security for American families. We do that with our primary focus making sure that in this time of the life sciences, the extraordinary breakthroughs we are seeing every single day, that the Food and Drug Administration is going to bring those new opportunities to American families but do it safely and do it efficaciously and do it in a way which is going to ensure that every family in America is going to have safe prescription drugs and safe products over which the FDA has jurisdiction. I thank my friend from Wyoming for all his good work. We are going to have a series of three votes, and then we may very well set a pathway, hopefully, toward a successful conclusion of this legislation. He and I are both eager to see this legislation in the conference to work out, with the House of Representatives, the points of difference with the House. We are also eager to work out the extremely important area of the follow-on biologics. It is an enormously important area of public health, and it is going to demand a great deal of time and careful attention to make sure we get that issue correct. It is important to not fail the American people but to see progress made in addressing this issue. The only way we can do it is make sure we get legislation that is going to pass the Senate, pass the House of Representatives, and move into conference. We are strongly committed to doing that. I commend our colleagues for all their good work and assistance. We had a rigorous markup in our committee for several hours. There were a number of different amendments. We have addressed the issue of food safety with the Durbin amendment. This issue has been on the front pages all over this country and all over the world, particularly with regard to pet food as well as food safety generally. This legislation will go a long way toward giving assurances to American families that all of our food products are going to be safe and secure. There are other provisions such as developing a nonprofit foundation so we can draw from the private sector and the public sector to make sure that agency is going to have the best of new techniques and new modalities, and to try to make sure the products that are before the Agency are going to be safe and secure and available as fast as possible. There will be a new emphasis in terms of science and also, as my friend from Wyoming points out, a toolbox that will be available to the FDA in order to ensure that we can get drugs more rapidly to the consumer but make sure they will be safer for American families, using the best of new technology, information technology, to make sure they are going to be more safe. I am enormously appreciative of the work of my friend from North Dakota, Senator Dorgan, on the issue of cost and price. Part of this is making sure we are going to have drugs that will be safe, but we also want to make them accessible and available. I commend him and all those who have been a part of this process. This is certainly an aspect of the prescription drug issue that we should constantly address. I thank Senator Roberts and Senator Harkin for working with Senator Enzi and me on the important issue of DTC, direct-to-consumer advertising. We have accomplished our common goal of a constitutionally sound, effective, workable way to make sure that DTC ads provide accurate information to patients about the drugs they are taking. This amendment strikes the moratorium on DTC ads that had given rise to Constitutional concerns, and I think we have a very solid resolution. I wish to thank Senators Stabenow, Brown, Lott, Thune, Coburn and Hatch for reaching agreement on the difficult issue of citizens petitions. Their amendment prohibits the abuse of the citizens petition process, a process that led to unwarranted delays in the approval process of FDA drugs, while making certain the FDA can review issues that have merit. The list also includes a novel proposal from Senator Brownback and Senator Brown to encourage the development of new therapies for neglected diseases. Under this innovative and thoughtful proposal, companies that have developed new treatments or vaccines for tropical diseases will receive a credit entitling them to a priority review at FDA for a product of their choosing. The proposal will not raise costs to consumers nor will it change safety standards. It is a very solid, imaginative, and creative approach. I commend Senator Hatch for his amendment on antibiotics, as well Senators Brown, Burr, Stabenow and others for contributing important proposals to this amendment. The amendment strikes the right balance between innovation and access, and closes a loophole that eliminated the incentives to bring old but never approved antibiotics to market. If there were more time, I would describe other amendments on the list, but I simply wish to thank all our colleagues. This issue is a matter of enormous importance and incredible consequence to the safety and security of the American consumer. This legislation brings the FDA into the 21st century. I commend my friend and colleague Senator Enzi for all his work. Most of all, I want to thank our staffs. They have been tireless, over this past week, on a variety of different amendments and prior to that time as we worked our way to the floor of the Senate. This is a very comprehensive bill. It is enormously important. We believe it will help in providing greater safety for American families, greater innovativeness in terms of breakthrough drugs and in terms of food safety, and greater opportunities for the FDA to have the best science there is. Mr. President, whatever remaining time that I have, I yield it to the Senator from Vermont. I yield the floor.

Mr. KENNEDY

Mr. KENNEDY. Madam President, if I could have the attention of the Senate, I was going to ask consent about a managers' amendment. Is it the intention of the Senator from North Dakota to object?

Mr. KENNEDY. I yield a minute to the Senator from North Dakota.

Mr. KENNEDY. I ask for the yeas and nays.

Mr. KENNEDY. Madam President, I request that the next vote be a 10- minute vote.

Mr. KENNEDY. Madam President, we yield back the remaining time, all time.

Mr. KENNEDY. I think we are ready to voice vote.

Mr. KENNEDY. Madam President, I ask unanimous consent that the managers' amendments be agreed to en bloc.

Mr. KENNEDY. Madam President, again, I thank all of the membership for their cooperation. We have been on this legislation for 1 week. We believe we have a managers' amendment which reflects the best judgment of Senator Enzi and myself and we will offer that at the appropriate time. I mentioned earlier during the debate and discussion, the essence of the managers' amendment. I think we probably have possibly two more votes that might require rollcall votes and then we would go to final passage. I think we have broad support for this legislation which is so essential if we are going to bring the FDA into the 21st century, and if we are going to assure safety for the prescription drugs our families take, insist on a safe food supply, and ensure that the FDA has the best in terms of science. I again thank my friend and colleague from Wyoming. I hope we can get a strong vote in favor of this bill.

Mr. KENNEDY. Madam President, 30 seconds. I was reminding the membership, as the Senator from West Virginia knows, this bill is going to ensure the safety of our pharmaceutical products. It is going to ensure the safety of our food products. It is going to insist that the FDA promote the latest in terms of science. We need to push the FDA into the 21st century, and this legislation will do it.

Mr. KENNEDY. Madam President, as far as I know, on this side, I think we have one amendment. We are inquiring of the Senator to see whether it will be offered. I think Senator Enzi can speak for the other side. We still have to work through the managers' amendment. I want to make it very clear that we are glad to get into the details of all that. I tried to summarize the managers' amendment. It involves a great many ideas from our side of the aisle. So, hopefully, we will be able to move that process. I know Members want to know how we are going to proceed now through the afternoon. We have good attendance, and we would like to at least give the membership an idea about how we are going to proceed. We have been on this legislation now for a week, and we have made very good progress. I think the vote on cloture demonstrates the strong support for this underlying legislation. We would like to move this legislation in a timely way and not delay it needlessly. So we will inquire of our colleagues further--if they have amendments, hopefully, they will let us know. Hopefully, we will have the opportunity to deal with the managers' amendment in a timely way. It would be unfortunate if we did not, since we have given assurance to Members on both sides of the aisle and worked long and hard with them to try to get this through. Obviously, any Senator is entitled to review the managers' amendment. We are getting very close to the point where we are prepared to move along with this legislation. This would seriously compromise a lot of colleagues who voted with the assurance that we were going to move ahead. We are more than delighted to get into the description of these various amendments and explain why we have recommended them. I hope we will not have delay for delay's sake, but that we will find a way to move forward.

Mr. KENNEDY. Madam President, I think it would be appropriate for the Senator to speak now. I thank him for his courtesy.

Mr. KENNEDY. I want to thank the Senator from Utah for introducing this important amendment. I am concerned with the alarming increase in the number of drug-resistant infections. Physicians from Massachusetts have written me in support of this amendment saying that patients are routinely lost to infections caused by resistant bacteria for which we have few to no options. I appreciate the efforts of infectious disease experts from the Infectious Diseases Society of America to raise these concerns and propose solutions.

Mr. KENNEDY. I appreciate the leadership of the Senator from West Virginia on this important issue. He has been a staunch advocate of consumer access to lower cost generic prescriptions, successfully working to include authorized generics in the Medicaid best price calculation. I support his efforts and believe that the bill before us includes significant provisions to lower prescription drug costs. While I know that our legislation does not directly address the Senator's concerns, I want to continue to work with him on this important issue and believe that we can reach consensus on authorized generics as part of the patent settlement debate.

Mr. KENNEDY

Mr. KENNEDY. Would the Senator from Wyoming yield me 3 minutes.

Mr. KENNEDY. Mr. President, we now have an agreement that we are going to vote on cloture on the Dorgan amendment. The Senator from North Dakota will be here to speak on that. He has a half hour. To bring our colleagues up to date, we have made very good progress during the evening, clearing matters with the Members. There are still a number of items that we will want to accept. We will indicate to the Members the topical areas so they will be familiar with the areas that we are moving ahead on. But we have narrowed the areas of controversy to probably four or five important areas where we may very well have votes during the day. The rest we will announce the agreements that have been made with the particular Senators on these issues. We want to thank all of our colleagues. This has been very constructive. A number of these suggestions and ideas are extremely valuable. We will tell our colleagues the areas and the content of these agreements as we move on through the day. We are in touch with a couple of Senators so we will be able to make a judgment decision at the conclusion of this vote on the cloture. We will be ready to go so we will not miss any opportunity to make progress on the bill. I thank the Senator. The Senate will now debate the underlying cloture motion.

Mr. KENNEDY. Mr. President, the Kohl amendment seeks to end abuse of the system for bringing generic drugs to the market. Under Hatch- Waxman, there is a sensible and balanced system for rewarding generic drug makers who enter the market first, but some companies have subverted this balanced system. Instead of allowing market forces to bring medicines to consumers at lower prices, companies collude to deny consumers the benefit of the lower cost drugs through ``reverse payments.'' Essentially, there is a payoff from the brand drug companies to the generic companies to split the benefits of the incentives provided under Hatch-Waxman. Everyone benefits under these arrangements, except consumers. Brand drug companies get further protection from competition, generics get payoffs and a guaranteed market. Only consumers get left behind, stuck with high prices and lesser competition. The Judiciary Committee reported legislation on this important issue. I commend Senator Kohl for his leadership. I know Senator Specter and Senator Hatch have important recommendations. I am sure we can work these matters out in a proposal to include the best ideas. We understand there are members of the Judiciary Committee who may want to speak to this amendment. I would hope the Senator would withhold further comments until we can see if there are members of the Judiciary Committee who want to address this amendment. I hope we will be able to include it and adopt it. I yield the floor.